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Launching an SPF range requires more planning than a standard skincare launch. Brands need to consider sunscreen regulation, SPF testing, claims, formulation complexity, packaging compatibility, manufacturing timelines and commercial positioning before moving from concept to market.

For beauty and skincare brands, SPF can be a powerful range extension. Daily sun protection is now a core part of modern skincare, and consumers are looking for sunscreen products that feel elegant, work under makeup, suit different skin types and align with their values.

But sunscreen is also one of the most technically demanding categories to launch. A successful SPF product needs to be more than appealing on shelf. It needs to perform reliably, meet relevant Australian requirements, remain stable in its packaging, support its claims and be manufacturable at commercial scale.

This guide explains what brands should know before launching an SPF range, including compliance, formulation, testing, manufacturing, branding and launch readiness considerations.

What Do Brands Need Before Launching Sunscreen?

Before launching sunscreen, brands need a clear product strategy, regulatory pathway, testing plan, packaging direction, manufacturing partner and commercial launch timeline.

An SPF launch should begin with a structured brief. This helps the formulation and manufacturing team understand what the brand wants to create and whether the concept is technically, commercially and regulatory feasible.

Before development begins, brands should define:

• The type of SPF product they want to launch
• The target SPF level
• The intended market and sales channels
• The desired claims and positioning
• The preferred formula type and skin feel
• The packaging format
• The target cost of goods
• The expected order volumes
• The launch date and retailer deadlines
• The level of regulatory and manufacturing support required

Brands that enter SPF development without a clear brief often lose time later. Claims may need to be revised, packaging may need to change, testing may take longer than expected, or the formula may need to be adjusted to achieve the desired performance.

How Are SPF Products Regulated in Australia?

In Australia, many sunscreen products are regulated as therapeutic goods when their primary purpose is UV protection.

This is one of the most important things brands need to understand before launching an SPF range. Sunscreen products are not always treated the same way as standard cosmetics. Depending on the product type, SPF level, intended purpose and claims, the product may need to meet therapeutic goods requirements before it can be supplied in Australia.

For brands, sunscreen compliance can influence:

• Which sunscreen actives can be used
• How the product is tested
• What claims can be made
• What must appear on the label
• Whether the product requires ARTG inclusion
• What manufacturing standards apply
• What documentation needs to be retained

Regulatory planning should happen early. A product concept that sounds simple from a marketing perspective may carry specific requirements once SPF, broad-spectrum or water-resistance claims are introduced.

Cosmetic SPF vs Therapeutic Sunscreen: What Is the Difference?

The difference between a cosmetic SPF product and a therapeutic sunscreen depends on the product’s purpose, claims and regulatory classification.

Some products may sit closer to cosmetic skincare, while others are clearly developed and marketed as sun protection products. Brands should confirm the likely pathway before investing heavily in formulation, packaging or campaign language.

This distinction matters because the product pathway affects the entire launch process. It can influence formulation decisions, testing requirements, documentation, label content, manufacturing controls and time to market.

What Testing Is Needed Before Selling Sunscreen?

SPF products need testing to support performance, quality, stability and claims before launch.

Testing should be planned into the project timeline from the beginning. It is not simply a final approval step after the product has been formulated. If testing identifies an issue, the formula, packaging or claims may need to be adjusted.

Depending on the product and claims, testing may include:

• SPF testing
• Broad-spectrum testing
• Water-resistance testing
• Stability testing
• Microbiological testing
• Preservative efficacy testing
• Packaging compatibility testing
• Claims substantiation

For SPF brands, testing timelines can be one of the biggest launch risks. A product that does not achieve its target SPF, broad-spectrum performance or stability requirements may need reformulation and retesting. This can affect retailer commitments, campaign timing and cash flow.

Why SPF Formulation Is More Complex Than Standard Skincare

SPF formulation is complex because the product must deliver measurable UV protection while still feeling pleasant on the skin.

Consumers expect modern sunscreens to be lightweight, non-greasy, easy to apply, compatible with makeup and suitable for daily use. At the same time, the formula needs to achieve its target SPF, remain stable, work with the selected packaging and be suitable for commercial manufacturing.

SPF formulation decisions may affect:

• SPF performance
• Broad-spectrum protection
• White cast
• Texture and spreadability
• Greasy or tacky after-feel
• Pilling under skincare or makeup
• Water resistance
• Stability over time
• Packaging compatibility
• Manufacturing efficiency

This is why SPF should not be treated as a simple skincare add-on. Adding sunscreen actives to an existing moisturiser concept may not create a product that performs, feels good and meets the required pathway. SPF products need to be designed as SPF products from the start.

How Can Brands Differentiate an SPF Range?

Brands can differentiate an SPF range through audience, texture, format, skin benefits, claims strategy, packaging and brand positioning.

The SPF category is competitive, so brands should avoid launching a generic sunscreen without a clear reason to exist. Differentiation should be built into the product strategy before formulation begins.

However, differentiation must still be realistic. Claims need to be supportable, the formula needs to be stable, packaging needs to work, and the product needs to be commercially viable at the intended price point.

What Claims Should SPF Brands Be Careful With?

SPF brands should be careful with any claim that relates to protection, duration, water resistance, skin safety, ingredient absence or therapeutic performance.

Claims are a common source of launch risk. Language that sounds appealing from a marketing perspective may create compliance concerns if it is inaccurate, unsupported or inconsistent with the product’s evidence.

Brands should take care with claims such as:

• Waterproof
• All-day protection
• Once-daily application
• Blocks all UV rays
• Chemical-free
• Non-toxic
• Safe for all skin types
• Dermatologist approved
• Reef safe
• Suitable for babies or children

This does not mean brands cannot make strong claims. It means claims should be planned, reviewed and supported by appropriate evidence. Packaging, website copy, advertising, social media and retailer descriptions should all align with the approved claims strategy.

What Manufacturing Logistics Should Brands Plan For?

SPF manufacturing requires planning around ingredients, packaging, testing, batch size, lead times, quality checks and production documentation.

Manufacturing is often where launch timelines become real. A brand may have a strong concept and approved formula, but production still depends on raw material availability, packaging supply, batch scheduling, filling requirements and quality release processes.

Brands should plan for:

• Raw material lead times
• Packaging procurement
• Packaging compatibility testing
• Manufacturing batch size
• Filling format
• Quality control checks
• Batch documentation
• Retain samples
• Finished goods release
• Freight and warehouse timing

For startup brands, it is important to understand minimum order quantities and cash flow implications. For established brands, the focus may be on scalability, retailer deadlines, repeat production and maintaining consistency across batches.

How Long Does an SPF Product Launch Take?

An SPF product launch usually takes longer than a standard skincare launch because it involves formulation, testing, compliance review, packaging and manufacturing stages.

Exact timing depends on the product complexity, regulatory pathway, claims, testing requirements and packaging. A simple product may move faster, while a highly customised SPF with specific sensory, water-resistance, tint, mineral-only or multi-market requirements may take longer.

The safest approach is to build contingency into the timeline. SPF launch delays often come from reformulation, failed testing, packaging changes, unsupported claims or late artwork revisions.

SPF Range Launch Checklist

A strong SPF launch plan should cover compliance, formulation, manufacturing, packaging and commercial readiness before production begins.

Before launching an SPF range, brands should ask:

• Have we confirmed the likely regulatory pathway?
• Are our SPF, broad-spectrum and water-resistance claims realistic?
• Have we selected a manufacturer with SPF experience?
• Is our formulation brief technically achievable?
• Have we allowed time for testing and possible reformulation?
• Has packaging been tested for compatibility?
• Are our claims supported by appropriate evidence?
• Has artwork been reviewed before printing?
• Have we planned raw material and packaging lead times?
• Do we understand minimum order quantities and production costs?
• Have we planned future production runs and replenishment?
• Do we have a clear launch position in the SPF category?

This checklist helps brands avoid treating SPF as a standard skincare launch. The earlier these questions are answered, the smoother the development and production process is likely to be.

Common Mistakes Brands Make When Launching SPF

The most common SPF launch mistakes happen when brands underestimate compliance, testing, formulation complexity or manufacturing timelines.

SPF can be commercially attractive, but it is not a category to rush. Mistakes made early in the process can lead to delays, additional costs, reformulation or claims changes close to launch.

Common mistakes include:

• Finalising packaging before confirming the formula
• Making claims before confirming the evidence required
• Assuming SPF is the same as standard skincare
• Underestimating testing timelines
• Choosing a manufacturer without SPF experience
• Ignoring packaging compatibility
• Setting unrealistic launch dates
• Trying to achieve too many product benefits in one formula
• Not planning for scale-up
• Leaving regulatory review too late

These issues are avoidable with the right development plan. A clear brief, experienced manufacturing partner and realistic timeline can help brands reduce risk before significant investment is committed.

How Delta Supports SPF Range Development

Delta supports beauty, skincare and sun care brands with SPF formulation, manufacturing and launch planning built around technical quality and commercial readiness.

Launching an SPF range requires decisions across formulation, compliance, testing, packaging, production and market positioning. Delta works with brands to help turn SPF concepts into manufacturable, market-ready products with the right planning in place from the beginning.

For SPF projects, Delta can support:

• Product concept development
• Custom SPF formulation
• Texture and sensory refinement
• Testing pathway planning
• Packaging compatibility considerations
• Manufacturing scale-up
• Quality-focused production
• Commercial production planning

With SPF, experience matters. The right manufacturing partner can help brands understand what is possible, what needs to be tested and where the biggest launch risks may appear.

FAQs About Launching an SPF Range

What Do Brands Need Before Launching Sunscreen?

Brands need a clear product concept, regulatory pathway, claims strategy, formulation brief, testing plan, packaging direction, manufacturing partner and commercial launch timeline. SPF products usually require more planning than standard skincare products.

How Are SPF Products Regulated in Australia?

In Australia, many sunscreen products are regulated as therapeutic goods when their primary purpose is UV protection. Depending on the product type and claims, brands may need to consider ARTG inclusion, permitted ingredients, sunscreen testing, labelling requirements and manufacturing standards.

What Testing Is Needed Before Selling Sunscreen?

Testing may include SPF testing, broad-spectrum testing, water-resistance testing, stability testing, microbiological testing, preservative efficacy testing, packaging compatibility testing and claims substantiation. The required testing depends on the product and claims.

How Do You Create a Sunscreen Brand?

Creating a sunscreen brand starts with a clear market position, target audience and product strategy. Brands then need to develop a compliant and commercially viable SPF formula, complete relevant testing, finalise packaging and manufacture the product with a suitable production partner.

Can an Existing Skincare Brand Add SPF to Its Range?

Yes, an existing skincare brand can add SPF to its range, but SPF development should be treated as a specialist project. The brand needs to consider sunscreen regulation, testing, claims, formulation complexity, packaging compatibility and manufacturing requirements.

Why Does SPF Development Take Longer Than Standard Skincare?

SPF development often takes longer because the product must achieve measurable sun protection performance, meet relevant regulatory and labelling expectations, remain stable and support claims with appropriate evidence. Reformulation or retesting can also add time.

What Should Brands Ask an SPF Manufacturer?

Brands should ask whether the manufacturer has SPF formulation experience, understands sunscreen compliance, can support testing pathways, can scale production, has suitable quality systems and can help identify technical risks before launch.

Launch Your SPF Range With the Right Foundations

Launching an SPF range can be a strong growth move for beauty and skincare brands, but it requires careful planning. The brands that succeed are the ones that treat SPF as a regulated, performance-led category from the beginning.

Before launch, brands should understand the regulatory pathway, formulate with testing in mind, choose packaging carefully, plan realistic timelines and work with a manufacturer that understands SPF development and production.

For skincare, sun care and health brands, entering a regulated category can be a valuable growth opportunity. Products such as therapeutic sunscreens can build consumer trust and create strong commercial differentiation, but they also come with higher expectations around compliance, quality systems and manufacturing controls.

This guide explains what brands should expect when working with a TGA-listed product manufacturer, including the difference between cosmetic and therapeutic products, what GMP manufacturing means, what documentation may be involved, and the questions to ask before choosing a manufacturing partner.

What Is a TGA-Listed Product?

A TGA-listed product is a therapeutic good that has been included in the Australian Register of Therapeutic Goods, commonly referred to as the ARTG.

In Australia, some products that sit close to skincare, sun care or personal care may be regulated as therapeutic goods depending on their ingredients, intended use, presentation and claims. For brands, this means the product development process may involve more than formulation and packaging. It may also require evidence, documentation, quality systems and appropriate manufacturing controls.

TGA-listed products are often identified by an AUST L number on the label. This number indicates that the product has been included in the ARTG as a listed therapeutic good. However, brands should not treat this as a simple labelling step. The regulatory pathway needs to be considered early, before claims, packaging and launch timelines are finalised.

Sunscreens as Therapeutic Goods in Australia

Many sunscreens in Australia are regulated as therapeutic goods because their primary purpose is to protect the skin from ultraviolet radiation.

This is especially relevant for brands developing SPF products such as facial sunscreens, body sunscreens, sport sunscreens, water-resistant sunscreens or high-SPF sun protection products. Depending on the product and its claims, sunscreen manufacturing may need to meet therapeutic goods requirements rather than standard cosmetic manufacturing expectations.

For brands, this can affect:

• Ingredient selection
• Permitted sunscreen actives
• SPF and broad-spectrum testing
• Water-resistance claims
• Artwork and labelling
• Manufacturing documentation
• Batch release requirements
• Product evidence and record keeping

Because sunscreen is a performance-led product, brands should work with a manufacturer that understands both formulation science and the compliance expectations surrounding therapeutic sunscreen production.

Differences Between Cosmetic and Therapeutic Claims

The difference between a cosmetic product and a therapeutic product often comes down to the product’s intended purpose and the claims made about it.

A cosmetic product may focus on appearance, cleansing, moisturising, fragrance or general skin feel. A therapeutic product, by contrast, may be presented as preventing, treating or protecting against a health-related condition or risk. In the case of sunscreens, UV protection and sunburn prevention can place products into a therapeutic framework.

Brands should be careful not to build their product concept around marketing claims before understanding whether those claims are suitable for the intended regulatory pathway.

What to Expect From a TGA-Compliant Manufacturer

A TGA-compliant manufacturer should provide structured quality systems, controlled production processes, clear documentation and experience working within regulated product categories.

For brands, the manufacturer is not just a production supplier. In regulated categories, the manufacturer is a critical partner in product quality, process control and evidence generation. The right partner can help brands understand what needs to be planned before production begins and what records must be maintained throughout the product lifecycle.

GMP Manufacturing Standards

GMP, or Good Manufacturing Practice, refers to the systems and controls used to ensure products are consistently manufactured to the required quality standard.

In the context of TGA-listed sunscreen manufacturing, GMP expectations can cover personnel, premises, equipment, documentation, production, quality control, outsourced activities, complaints, recall processes, validation and reference samples.

For brands, this means the manufacturing process is expected to be controlled and repeatable. Ingredients should be checked, equipment should be suitable, procedures should be documented, batches should be traceable and finished products should be assessed before release.

Documentation and Quality Systems

Documentation is one of the biggest differences between standard cosmetic development and TGA-listed product manufacturing.

Brands should expect more formal records at each stage of development, manufacturing and release. Documentation may vary depending on the product and pathway, but it commonly supports the product’s formulation, quality, testing, manufacturing process and finished specifications.

Common documentation may include:

• Approved formula records
• Raw material specifications
• Finished product specifications
• Manufacturing instructions
• Batch manufacturing records
• Quality control records
• SPF and performance testing reports
• Stability testing reports
• Microbiological testing records
• Packaging specifications
• Artwork and label review records
• Release documentation
• Retain sample records

Clear documentation helps protect both the brand and the manufacturer. It provides a record of what was made, how it was made, what was tested and whether the product met the required specifications.

Batch Traceability and Quality Assurance

Batch traceability allows a manufacturer to track the materials, process steps, testing and release status of each production batch.

This is particularly important for TGA-listed products because quality issues must be investigated in a structured way. If a question arises about a finished product, the manufacturer should be able to trace the batch back through raw materials, processing records, equipment, operators, testing results and packaging components.

Quality assurance may include checks such as:

• Raw material approval
• Supplier documentation review
• In-process checks
• Finished product testing
• Batch record review
• Deviation management
• Release approval
• Retain sample storage

For brands, this level of traceability gives greater confidence that the product can be manufactured consistently across future production runs.

The Role of Testing in TGA-Listed Products

Testing is central to TGA-listed product manufacturing because claims, quality and product performance need to be supported by appropriate evidence.

Testing should not be treated as a final administrative step. For regulated products, the testing pathway should be considered during formulation development, packaging selection and launch planning. If testing identifies an issue, the formula, packaging, claim or manufacturing process may need to be adjusted.

SPF Testing Requirements

For therapeutic sunscreens, SPF testing supports the sun protection claim made on the product label.

SPF testing is a critical part of sunscreen development because the claimed SPF level must be supported by suitable evidence. Depending on the product, testing may also be required to support broad-spectrum claims, water resistance claims or other performance-related statements.

Brands should allow enough time for testing, review and potential reformulation. If a product does not achieve the target SPF or claim profile, additional development work may be required before the product can proceed.

Stability and Microbiological Testing

Stability and microbiological testing help confirm that the product remains suitable, consistent and safe throughout its intended shelf life.

Stability testing may assess changes in appearance, odour, colour, viscosity, pH, separation, packaging compatibility and product performance under defined conditions. Microbiological testing helps assess product quality and preservative system performance.

For SPF products, stability is especially important because changes in the formulation can affect consumer experience, product quality and confidence in performance. Packaging should also be assessed because the wrong pack can create issues with leakage, dispensing, compatibility or product protection.

Questions Brands Should Ask Potential Manufacturers

Choosing a manufacturer for TGA-listed products should involve more than comparing pricing and minimum order quantities.

Brands should assess whether the manufacturer has the right experience, quality systems, technical capability and regulatory awareness to support the product from development through to production.

Experience With Sunscreen Formulation

SPF formulation is highly specialised, so brands should ask whether the manufacturer has experience developing and scaling sunscreen products.

Useful questions include:

• Have you developed therapeutic sunscreen products before?
• Do you support custom SPF formulation?
• Can you advise on UV filter strategy and formulation feasibility?
• Can you help identify risks before testing begins?
• Do you understand SPF, broad-spectrum and water-resistance claim requirements?

Regulatory Support Capabilities

A manufacturer should be clear about what regulatory support they can provide and where a separate regulatory consultant or sponsor responsibility may be required.

Brands should ask:

• What documentation can you provide to support the product record?
• Can you support artwork and label review from a manufacturing perspective?
• Can you guide testing requirements and timing?
• Do you have experience working with TGA-listed products?
• What information does the brand need to provide before production?

Production Scalability and Lead Times

The right manufacturer should be able to support both the first production run and future scale-up requirements.

Brands should ask:

• What batch sizes can you support?
• What are typical production lead times?
• How are raw material lead times managed?
• Can the formula be scaled without compromising quality?
• What quality checks happen before batch release?

Manufacturer Selection Checklist

Before choosing a TGA-listed product manufacturer, brands should confirm that the partner can support the technical, quality and documentation needs of the product.

Common Challenges in TGA-Listed Product Manufacturing

The most common challenges in TGA-listed product manufacturing come from underestimating the time, evidence and documentation required.

Brands often encounter issues when they finalise claims too early, choose packaging before compatibility testing, underestimate testing timelines or assume a sunscreen can be treated like a standard cosmetic moisturiser.

Common challenges include:

• Unclear regulatory pathway
• Unsupported marketing claims
• SPF results below the target claim
• Stability failures
• Packaging compatibility issues
• Incomplete documentation
• Raw material supply delays
• Scale-up changes between lab and production
• Artwork revisions close to launch
• Unrealistic production timelines

These challenges can usually be managed with early planning. Brands should involve their manufacturer before finalising claims, artwork, packaging or retailer launch dates.

Why Experience Matters in SPF Manufacturing

Experience matters because SPF manufacturing requires a combination of formulation skill, process control, testing awareness and quality discipline.

Sunscreen products need to perform reliably while still meeting consumer expectations for texture, finish, packaging and usability. This makes formulation and manufacturing more complex than many standard skincare products.

An experienced SPF manufacturer can help brands understand what is technically achievable, what needs to be tested, what documentation may be required and where development risks may appear. This can help reduce avoidable delays and support a more confident path to market.

How Delta Supports TGA-Listed Product Manufacturing

Delta supports brands developing regulated sunscreen and therapeutic-style products with formulation, manufacturing and quality-focused production capability.

For brands entering TGA-listed product categories, Delta provides a structured manufacturing partnership built around technical knowledge, quality systems and commercial production experience. This includes support across product development, formulation feasibility, testing pathways, documentation, scale-up and production planning.

Delta’s role is to help brands move through the manufacturing process with greater clarity, from early product development through to finished goods production. For SPF and regulated topical products, this means considering performance, stability, packaging, documentation and manufacturing controls from the beginning.

FAQs About TGA-Listed Manufacturing

What Is a TGA-Listed Sunscreen?

A TGA-listed sunscreen is a sunscreen product that has been included in the Australian Register of Therapeutic Goods as a listed therapeutic good. These products commonly carry an AUST L number and must meet applicable requirements for ingredients, claims, evidence, labelling and manufacturing.

What Does GMP Manufacturing Mean?

GMP stands for Good Manufacturing Practice. It refers to the systems, processes and controls used to ensure products are manufactured consistently and meet defined quality standards. For therapeutic sunscreens, GMP can apply to areas such as documentation, production, quality control, premises, equipment, complaints and batch release.

How Do Manufacturers Support TGA Compliance?

Manufacturers can support TGA compliance by producing products under appropriate quality systems, maintaining batch documentation, following controlled manufacturing processes, supporting testing requirements and helping brands understand manufacturing-related documentation. Regulatory responsibilities can vary, so brands should confirm roles clearly at the start of the project.

What Documentation Is Needed for TGA-Listed Products?

Documentation may include approved formulas, specifications, raw material records, batch manufacturing records, quality control results, testing reports, packaging specifications, artwork records, release documentation and retain sample records. The exact requirements depend on the product and regulatory pathway.

Is TGA-Listed Sunscreen Manufacturing Different From Cosmetic Manufacturing?

Yes. TGA-listed sunscreen manufacturing generally involves higher expectations around evidence, documentation, quality systems and manufacturing controls than standard cosmetic manufacturing. Brands should work with a manufacturer that understands the requirements of regulated sunscreen production.

When Should a Brand Speak to a Manufacturer?

Brands should speak to a manufacturer as early as possible, ideally before finalising the formula brief, claims, packaging or launch date. Early manufacturing input can help identify technical, testing and documentation requirements before they become costly delays.

Work With the Right Manufacturer From the Start

Working with a manufacturer for TGA-listed products requires planning, structure and trust. The right partner should help brands understand what to expect across formulation, testing, documentation, quality control and production.

For sunscreen and regulated topical products, early decisions can have a major impact on compliance, performance and launch timing. Choosing an experienced manufacturing partner can help brands reduce uncertainty and move through the process with greater confidence.

Developing an SPF product requires more than choosing UV filters and creating a pleasant texture. Brands need to consider regulatory classification, formulation strategy, SPF and broad-spectrum testing, stability, packaging compatibility, manufacturing scale-up and launch timelines.

A typical SPF development process includes:

1. Defining the product concept and market positioning
2. Confirming the regulatory pathway
3. Building the sunscreen formulation strategy
4. Developing and refining prototypes
5. Conducting stability and compatibility testing
6. Completing SPF, broad-spectrum and claims testing
7. Finalising packaging and artwork
8. Scaling up to manufacturing
9. Completing quality checks and release requirements
10. Launching with compliant claims and supporting evidence

For Australian brands, working with an experienced SPF manufacturer can help reduce risk, improve development efficiency and ensure technical requirements are considered from the beginning.

What Is SPF Product Development?

SPF product development is the end-to-end process of creating a sunscreen or SPF-containing product that is formulated, tested, manufactured and prepared for market.

At a simple level, it involves turning a product idea into a finished sunscreen that consumers can buy and use. In practice, it is a highly technical process involving formulation science, regulatory planning, ingredient selection, performance testing, packaging decisions and commercial scale manufacturing.

An SPF product may be developed as a standalone sunscreen, a daily facial SPF, a tinted sunscreen, an SPF moisturiser, an after-sun adjacent range extension, or a specialist product for sport, family, sensitive skin or outdoor use. Each product type comes with different formulation and compliance considerations.

The most successful SPF projects start with a clear brief. A manufacturer or formulation partner needs to understand what the product is intended to do, who it is for, what claims the brand wants to make, the desired texture and finish, the target price point, packaging preferences and the expected launch timeline.

Step 1: Define the SPF Product Concept

The first stage is to clearly define what the sunscreen product should be and where it will sit in the market.

Before formulation begins, brands should clarify the product’s role in the range. Is it a daily facial sunscreen? A body SPF? A sport sunscreen? A mineral-only formula? A tinted SPF? A moisturiser with SPF? These decisions shape the formulation, testing requirements, packaging choices and commercial strategy.

A strong SPF brief should include:

• Product type and format
• Target SPF level
• Desired texture and finish
• Skin type or consumer segment
• Preferred active ingredient approach
• Claims the brand wants to make
• Packaging format
• Target cost of goods
• Expected order volumes
• Launch timing
• Retail or distribution channel

This stage is also where brands should assess whether their concept is technically realistic. For example, a high SPF, ultra-light, mineral-only, water-resistant, fragrance-free, low-cost product may be possible in some form, but it may require trade-offs across skin feel, whiteness, cost, packaging or development time.

The clearer the concept, the easier it is to develop a formula that balances brand vision with technical reality.

Step 2: Confirm the Regulatory Pathway

In Australia, many sunscreen products are regulated as therapeutic goods, which means compliance needs to be considered before formulation starts.

This is one of the most important steps in SPF product development. Sunscreens are not always treated like standard cosmetics, especially when their primary purpose is UV protection. Depending on the product type, claims, SPF level and intended use, the sunscreen may need to meet specific therapeutic goods requirements before it can be supplied in Australia.

Brands should consider:

• Whether the product is a primary or secondary sunscreen
• Whether it requires inclusion in the Australian Register of Therapeutic Goods
• Which active sunscreen ingredients are permitted
• What claims can and cannot be made
• What evidence is required to support performance claims
• What labelling requirements apply
• Whether the manufacturer has the right capabilities and quality systems

This is where early regulatory guidance is critical. A concept that sounds simple from a marketing perspective may carry specific compliance obligations once SPF claims are introduced.

For brands planning to sell in multiple markets, regulatory planning becomes even more important. Australia, the United States and the European Union do not treat sunscreen products in exactly the same way. A formula or claim strategy that works in one market may need adjustment for another.

Step 3: Build the Sunscreen Formulation Strategy

Sunscreen formulation is highly specialised because the formula must deliver both protection and a desirable user experience.

The formulation strategy determines how the product will achieve its SPF performance, texture, stability and sensory profile. It includes decisions around UV filters, emulsifier systems, preservatives, moisturising ingredients, film formers, thickeners, antioxidants, fragrance, colourants and supporting skin-benefit ingredients.

A custom SPF formulation may need to balance:

• UV protection
• Broad-spectrum performance
• Water resistance
• Skin feel
• Spreadability
• White cast
• Greasiness
• Pilling
• Eye sting
• Stability
• Packaging compatibility
• Cost
• Manufacturing efficiency

One of the biggest challenges in sunscreen formulation is that every ingredient can affect performance. The UV filters may determine the protection profile, but the emulsion structure, oil phase, film formation, viscosity and packaging can all influence how the product behaves.

This is why SPF products are rarely simple “add SPF to skincare” projects. A moisturiser with SPF still needs to be developed as an SPF product, not just a moisturiser with sunscreen actives added at the end.

Step 4: Choose the Right UV Filter Approach

The UV filter system is central to how a sunscreen performs, feels and is positioned.

UV filters are ingredients that help protect the skin from ultraviolet radiation. Sunscreen products may use chemical filters, mineral filters or a combination of both. Each approach has advantages and challenges.

The best UV filter strategy depends on the product goal. A lightweight daily facial SPF may need a different approach from a water-resistant body sunscreen or a mineral-only baby-positioned product.

Brands should avoid choosing filters based on marketing preference alone. The filter system needs to be considered alongside target SPF, skin feel, regulatory status, supply chain availability, manufacturing process and testing pathway.

Step 5: Develop and Refine Prototypes

Prototype development turns the concept and formulation strategy into sample products that can be evaluated and improved.

The first prototype is rarely the final formula. SPF product development usually requires several rounds of formulation adjustment to balance performance, aesthetics, stability and manufacturability.

During prototype refinement, the formulation team may assess:

• Texture and spreadability
• Absorption and finish
• White cast or transparency
• Pilling under skincare or makeup
• Fragrance profile
• Viscosity
• Water resistance potential
• Compatibility with packaging
• Early stability indicators
• Manufacturing practicality

Feedback at this stage should be structured. Rather than simply saying a sample feels “too heavy” or “not premium enough”, brands should describe the desired direction. For example: lighter after-feel, faster rub-in, less shine, more cushion, softer finish, lower tack, better makeup compatibility or less visible residue.

This helps the formulation team make targeted adjustments instead of guessing.

Step 6: Conduct Stability and Compatibility Testing

Stability testing helps confirm whether the formula remains safe, consistent and suitable over time.

For SPF products, stability is especially important because product performance depends on the formula remaining physically and chemically consistent. Changes in viscosity, separation, odour, colour, pH, microbial quality or packaging interaction can affect consumer experience and potentially compromise product quality.

Stability testing may assess the product under different conditions, such as elevated temperature, room temperature, light exposure or freeze-thaw cycles. Packaging compatibility testing assesses how the formula behaves in the intended pack.

Common issues found during SPF stability work include:

• Formula separation
• Viscosity drift
• Grittiness or crystallisation
• Colour or odour change
• Preservative system issues
• Packaging swelling, leakage or staining
• Pump or closure performance problems
• Changes in application feel

Packaging should not be finalised too late in the process. A formula may behave well in a lab jar but perform differently in a tube, pump, airless pack or spray format. Testing the formula in the intended packaging helps reduce the risk of launch issues.

Step 7: Complete SPF and Performance Testing

SPF testing verifies whether the product achieves the level of sun protection it intends to claim.

Testing is a critical milestone in sunscreen product development. Brands need evidence to support SPF, broad-spectrum, water resistance and other performance claims where relevant.

The testing pathway depends on the product type and claims, but may include:

• SPF testing
• Broad-spectrum testing
• Water resistance testing
• Stability testing
• Microbiological testing
• Preservative efficacy testing
• Compatibility testing
• Claims substantiation

SPF testing is not just a box to tick at the end. If a product does not achieve the intended SPF or claim profile, reformulation may be required, followed by further testing. This can add time and cost to the development process.

This is why experienced SPF formulators often build testing considerations into the formula from the start. Early technical decisions can influence the likelihood of achieving the desired SPF, skin feel and stability profile.

Step 8: Finalise Packaging and Artwork

Packaging and artwork need to support both product performance and regulatory compliance.

For SPF products, packaging is not only a branding decision. The packaging format can affect stability, usability, dosing, product protection and consumer experience. It also needs to accommodate the required labelling information.

Packaging decisions may include:

• Tube, pump, airless, bottle, jar or spray format
• Fill volume
• Closure system
• Barrier properties
• Dispensing behaviour
• Decoration method
• Label space
• Retail presentation
• Transport durability
• Compatibility with the formula

Artwork should be reviewed carefully before printing. SPF products may require specific information on pack, including SPF level, usage directions, active ingredients, warnings, storage instructions, AUST L details where relevant, and compliant claims language.

Brands should be particularly careful with marketing claims. Words such as “waterproof”, “all-day protection” or “chemical-free” can create compliance concerns. Claims should be accurate, supportable and aligned with applicable requirements.

Step 9: Scale Up to Manufacturing

Manufacturing scale-up ensures the product can be made consistently beyond the lab bench.

A formula that works in a small laboratory batch still needs to be translated into a commercial manufacturing process. This involves confirming mixing order, processing temperatures, equipment requirements, batch size, filling parameters, quality checks and production documentation.

Scale-up considerations may include:

• Ingredient sourcing and lead times
• Manufacturing method
• Batch size
• Mixing and homogenisation requirements
• Heating and cooling controls
• Filling process
• In-process quality checks
• Finished product specifications
• Retain samples
• Documentation and release procedures

For SPF products, consistency is especially important. The manufacturing process must support uniform distribution of UV filters and maintain the intended product structure. Poor scale-up can affect texture, stability, fill performance or product quality.

Working with a manufacturer experienced in sunscreen product development can help brands identify scale-up risks early and avoid delays close to launch.

Step 10: Prepare for Commercial Launch

A successful SPF launch depends on having the right product evidence, compliant claims and supply planning in place.

By the time the product is ready for launch, the brand should have confirmed the formula, packaging, testing, regulatory pathway, manufacturing process and launch claims. Commercial planning should also account for production lead times, packaging supply, stock forecasts, retail deadlines and marketing approvals.

Before launch, brands should check:

• Is the final formula approved?
• Has testing been completed and documented?
• Are claims supported by evidence?
• Has artwork been reviewed?
• Is packaging compatible with the formula?
• Are manufacturing and release specifications confirmed?
• Are regulatory obligations understood?
• Is the launch timeline realistic?
• Is there a plan for future production runs?

SPF products often require longer development timelines than standard skincare products. Brands should allow enough time for formulation, testing, regulatory review, packaging procurement and manufacturing.

How Long Does SPF Product Development Take?

SPF development timelines vary depending on complexity, testing requirements, packaging and regulatory pathway.

As a general guide, brands should expect an SPF product to take longer than a standard cosmetic formulation. Simple line extensions may move faster if the formulation pathway is clear, while custom SPF products with specific sensory, claims or packaging requirements may take significantly longer.

The biggest causes of delay are unclear briefs, late packaging changes, failed stability tests, SPF results below the target claim, ingredient supply issues and artwork or compliance revisions.

A realistic timeline should include room for reformulation and retesting. Building contingency into the development plan is usually more effective than trying to rush testing at the end.

Can Cosmetic Brands Create Custom Sunscreen Formulas?

Yes, cosmetic and skincare brands can create custom sunscreen formulas, but SPF development requires specialist formulation and regulatory expertise.

A custom SPF formulation can help a brand create a differentiated product with a specific texture, finish, claim profile or skin-benefit positioning. This may be valuable for brands that want to move beyond generic sunscreen formats and create a product that fits their range identity.

Custom SPF development can support:

• Daily facial sunscreen
• Mineral sunscreen
• Tinted SPF
• Moisturising SPF
• Sensitive skin SPF
• Sport or outdoor SPF
• Premium skincare-led SPF
• Water-resistant sunscreen
• Hybrid sunscreen formulas

However, custom does not mean unlimited flexibility. Sunscreen formulas must still meet technical, testing and compliance requirements. A strong development partner will help identify where the brand can differentiate and where the formula must stay within proven performance boundaries.

Common SPF Development Challenges

Most SPF development challenges come from trying to balance performance, feel, compliance and commercial requirements at the same time.

Common challenges include:

• Achieving the target SPF without compromising skin feel
• Reducing white cast in mineral or hybrid formulas
• Preventing pilling under makeup
• Managing greasiness or tack
• Maintaining stability over time
• Supporting broad-spectrum or water-resistance claims
• Selecting compliant and available ingredients
• Choosing packaging that protects the product
• Managing testing timelines
• Keeping cost of goods commercially viable

These challenges are manageable when they are considered early. Problems become more expensive when they are discovered after packaging is ordered, artwork is printed or launch commitments have been made.

Choosing an SPF Manufacturer in Australia

Choosing the right SPF manufacturer is one of the most important decisions in the development process.

SPF products require a manufacturer with the technical capability, quality systems and regulatory understanding to support sunscreen development from concept through to production. Brands should look for a partner that understands formulation, testing, compliance, scale-up and commercial realities.

When assessing an SPF manufacturer, ask:

• Do they have experience developing sunscreen products?
• Can they support custom SPF formulation?
• Do they understand Australian sunscreen requirements?
• Can they guide testing and evidence requirements?
• Do they have appropriate quality systems?
• Can they manufacture at the required scale?
• Can they support packaging and compatibility considerations?
• Can they help identify risks early?
• Do they understand both formulation and commercialisation?

For emerging brands, the right manufacturer can provide clarity and structure. For established brands, they can support innovation, scale, quality and speed to market.

How Delta Supports SPF Product Development

Delta supports brands through the technical and commercial stages of SPF product development, from formulation strategy through to manufacturing.

As an Australian formulation and manufacturing partner, Delta works with skincare and personal care brands to develop products that are commercially viable, technically robust and aligned with the brand’s market goals.

For SPF projects, this can include support across:

• Product concept development
• Custom SPF formulation
• Prototype development
• Ingredient and texture strategy
• Stability and compatibility planning
• Testing pathway guidance
• Packaging considerations
• Manufacturing scale-up
• Quality processes
• Commercial production

Developing sunscreen requires confidence at every stage. With the right formulation and manufacturing partner, brands can move through the process with greater clarity, fewer avoidable delays and a stronger foundation for launch.

FAQ: SPF Product Development

How do you develop an SPF product?

Developing an SPF product starts with a clear product brief, followed by regulatory pathway review, formulation strategy, prototype development, stability and compatibility testing, SPF and claims testing, packaging finalisation, manufacturing scale-up and commercial launch.

What testing is required for sunscreen in Australia?

Testing requirements depend on the product type and claims, but sunscreen products commonly require SPF testing, broad-spectrum testing, stability testing, microbiological testing, preservative efficacy testing, packaging compatibility testing and evidence to support any performance or marketing claims.

How long does SPF development take?

SPF development timelines vary depending on the formula complexity, packaging, testing pathway and regulatory requirements. Brands should allow more time than they would for a standard cosmetic product because sunscreen development often involves specialist testing, compliance review and potential reformulation.

Can cosmetic brands create custom sunscreen formulas?

Yes. Cosmetic and skincare brands can create custom sunscreen formulas with the right formulation and manufacturing partner. However, custom SPF products still need to meet relevant performance, testing, labelling and regulatory requirements.

What is required for TGA-listed sunscreen products?

TGA-listed sunscreen products need to meet applicable Australian requirements, including permitted ingredient rules, relevant sunscreen standards, evidence for claims, compliant labelling and inclusion in the Australian Register of Therapeutic Goods where required.

What makes SPF formulation difficult?

SPF formulation is difficult because the product must deliver reliable UV protection while still feeling pleasant on the skin. The formula must also remain stable, work with the chosen packaging, support claims and be suitable for commercial manufacturing.

When should brands speak to an SPF manufacturer?

Brands should speak to an SPF manufacturer as early as possible, ideally before finalising claims, packaging or launch timelines. Early technical input can help avoid unrealistic briefs, unsuitable packaging choices and compliance issues later in the process.

Developing an SPF Product Starts With the Right Partner

SPF product development is a technical journey that requires planning, testing and specialist expertise. From the first concept through to final manufacturing, every decision can influence the product’s performance, compliance, stability and commercial success.

For brands developing sunscreen in Australia, the best results come from building the right foundations early: a clear brief, a realistic development plan, a compliant claims strategy, suitable packaging and an experienced formulation and manufacturing partner.

Delta helps skincare and personal care brands navigate the SPF product development process with confidence, from concept and formulation through to testing, scale-up and commercial production.

For sunscreen brands, formulators and regulatory teams, understanding these differences is essential for avoiding delays, failed compliance checks or costly reformulations.

This guide provides a practical overview of sunscreen regulations in Australia, the United States and the European Union, helping brands understand key compliance requirements and prepare products for international markets.

Why Sunscreen Regulations Differ Globally

Sunscreens are regulated under different frameworks depending on the country or region.

Some markets classify sunscreens as:

• Therapeutic goods
• Over-the-counter drugs
• Cosmetic products

These classifications influence:

• Approved UV filters
• SPF testing requirements
• Broad-spectrum standards
• Product claims
• Packaging and labelling rules

As a result, a sunscreen that is compliant in one market may require additional testing, documentation or reformulation to be sold elsewhere.

Understanding SPF regulatory requirements early in development can help brands streamline launches and reduce compliance risks.

Sunscreen Regulations in Australia

Australia has some of the strictest sunscreen regulations globally due to the country’s high UV exposure and skin cancer rates. Sunscreens are regulated by the Therapeutic Goods Administration, commonly known as the TGA.

TGA Classification of Sunscreens

Australian sunscreens are generally classified as either primary sunscreens or secondary sunscreens.

Primary sunscreens are regulated as therapeutic goods and must comply with TGA requirements. Secondary sunscreens may be exempt from some therapeutic regulations depending on SPF level, product type and intended use, but claims still need to be appropriately supported.

Required Testing and Labelling

Australian sunscreen products must comply with recognised standards and may require:

• SPF testing
• Broad-spectrum UVA protection testing
• Water resistance testing, if claimed
• Stability and microbiological assessments
• Compliant labelling and claim substantiation

Products are commonly assessed according to Australian and New Zealand sunscreen standards, as well as internationally recognised ISO methods where applicable.

Key Labelling Requirements

Australian sunscreen labels generally include:

• SPF value
• Broad-spectrum claim, where supported by testing
• Water resistance duration, where claimed
• Directions for use
• Active ingredients

Australia commonly uses SPF 50+ as the highest labelled SPF category, even where test results exceed that value.

Because the Australian framework is highly regulated, brands entering the market often require careful testing, documentation and compliance planning.

Sunscreen Regulations in the United States

In the United States, sunscreens are regulated by the Food and Drug Administration, known as the FDA, as over-the-counter drug products.

This makes the US one of the most structured sunscreen markets globally.

FDA OTC Sunscreen Framework

The FDA sunscreen framework outlines requirements relating to:

• Approved UV filters
• Permitted active ingredient concentrations
• Testing methods
• Label requirements
• Acceptable marketing claims

Compared with some other regions, the US has a more limited list of permitted sunscreen actives, which can create formulation challenges for global brands.

Broad-Spectrum and SPF Requirements

To market sunscreen products in the US, brands must perform testing aligned with FDA requirements.

This typically includes:

• SPF testing
• Broad-spectrum UVA testing
• Water resistance testing, if claimed

Broad-Spectrum Claims

Products must pass FDA broad-spectrum testing to claim protection against both UVA and UVB radiation.

If a product does not pass broad-spectrum testing:

• It may still display an SPF value
• It cannot claim broad-spectrum protection
• It may face additional claim limitations

Water Resistance Claims

The FDA does not allow sunscreen claims such as:

• Waterproof
• Sweatproof
• Sunblock

Instead, products may only claim validated water resistance durations such as:

• Water resistant, 40 minutes
• Water resistant, 80 minutes

Drug Facts Panel

US sunscreen labels must also include a standardised Drug Facts panel outlining key product information such as:

• Active ingredients
• Warnings
• Directions
• Usage information

This differs significantly from EU cosmetic labelling requirements and is one of the most important packaging considerations for brands entering the US sunscreen market.

Sunscreen Regulations in the European Union

In the European Union, sunscreens are regulated as cosmetic products under the EU Cosmetics Regulation framework. Unlike Australia and the US, sunscreens are not classified as therapeutic goods or drug products.

Cosmetics Regulation Framework

EU sunscreen products must comply with requirements relating to:

• EU Cosmetics Regulation requirements
• European Commission sunscreen recommendations
• Product safety assessment
• Ingredient safety rules
• Responsible claims and substantiation

Manufacturers are responsible for ensuring products are safe, effective and supported by appropriate testing and documentation.

The EU framework focuses strongly on:

• Consumer safety
• Responsible marketing claims
• Scientific substantiation
• Product information and safety documentation

UVA Protection Factor Requirements

The EU expects sunscreens to provide balanced UVA protection alongside SPF performance.

To support UVA protection claims, the UVA protection factor should be at least one-third of the labelled SPF value.

Products meeting these expectations may display the recognised UVA logo on packaging, where relevant requirements are met.

EU sunscreen testing commonly uses:

• ISO 24444 for SPF testing
• ISO 24443 for UVA testing

The EU also restricts misleading or exaggerated sunscreen claims, helping ensure consumers receive clear and accurate information about product protection.

Key Differences Between Australia, the EU and US

Although sunscreen regulations share similar goals, each region applies different compliance pathways.

Regulatory Classification Comparison

These classifications affect registration requirements, documentation, permitted ingredients and the types of claims brands can make.

Testing Standards

While ISO standards are widely recognised internationally, the FDA maintains some market-specific requirements that brands need to consider early in development.

Labelling Rules

Because labelling rules differ, many global sunscreen brands require region-specific packaging, claims and compliance documentation.

Preparing Your Sunscreen for Global Compliance

Developing sunscreen products for multiple international markets requires early regulatory planning.

Review Ingredient and Claim Requirements Early

Brands should confirm:

• Approved UV filters in target markets
• Maximum ingredient concentrations
• Broad-spectrum requirements
• SPF claim expectations
• Water resistance claim requirements

This helps reduce the risk of reformulation later in development.

Validate Product Performance

Global sunscreen products commonly require:

• SPF testing
• UVA testing
• Stability testing
• Water resistance validation
• Microbiological testing where relevant

Early-stage in vitro testing can help identify formulation weaknesses before final validation testing begins.

Work With Experienced Testing Partners

Global sunscreen compliance involves more than achieving a target SPF number.

Brands also need support with:

• Regulatory expectations
• Test selection
• Claim substantiation
• Documentation requirements
• Market-specific interpretation

Working with experienced laboratories helps streamline compliance and reduce delays during launch preparation.

FAQ: Sunscreen Regulations

Are sunscreens regulated differently in each country?

Yes. Sunscreens may be classified as therapeutic goods, over-the-counter drugs or cosmetic products depending on the region.

What are the TGA sunscreen requirements?

The TGA requires recognised SPF and broad-spectrum testing, compliant labelling and adherence to Australian sunscreen standards for regulated therapeutic sunscreen products.

What are FDA sunscreen regulations?

The FDA regulates sunscreens as over-the-counter drugs and requires approved active ingredients, SPF testing, broad-spectrum validation where claimed and Drug Facts labelling.

What are EU sunscreen regulations?

The EU regulates sunscreens as cosmetic products and requires product safety substantiation, SPF validation, UVA protection standards and responsible claims.

Why is international sunscreen compliance challenging?

Different testing standards, ingredient approvals, product classifications and labelling rules across regions make global sunscreen compliance complex.

Support Global Sunscreen Compliance With Delta

Navigating international sunscreen regulations requires strong testing, clear documentation and an understanding of market-specific compliance expectations.

Delta supports sunscreen brands with SPF testing, UVA validation and regulatory-aware testing programs aligned with Australian, US and EU requirements.

Launching sunscreen products internationally? Delta can help ensure your products meet global testing and regulatory standards.

What Is Product Stability Testing?

Product stability testing evaluates how a product’s physical, chemical and microbiological properties change over time under different environmental conditions. The goal is to determine whether a formulation remains stable and safe throughout its intended shelf life.

For manufacturers, stability testing provides the scientific data needed to support:

• Shelf-life claims
• Packaging compatibility
• Regulatory compliance
• Product quality and safety

Without a structured stability testing protocol, it’s difficult to confirm that a product will remain effective during storage, transport and everyday use.

Purpose and Importance

Stability testing helps answer critical questions during product development and regulatory review:

• How long will the product remain safe and effective?
• Will the formulation separate, degrade or change colour?
• Does the packaging protect the product adequately?
• How do temperature, humidity and light exposure affect performance?

For cosmetic and pharmaceutical brands alike, stability testing is a key step in reducing risk before launch. It ensures consumers receive products that perform consistently from the first use to the last.

Types of Stability Testing

A comprehensive product stability testing program typically evaluates several characteristics.

Physical Stability

Physical testing looks at visible and structural changes in the product, such as:

• Colour changes
• Phase separation
• Texture or viscosity changes
• Sedimentation or crystallisation

These factors can affect both product performance and consumer perception.

Chemical Stability

Chemical testing monitors whether active ingredients and other components degrade over time. This ensures:

• Active ingredient potency remains within acceptable limits
• No harmful degradation products form
• The formulation remains chemically balanced

Microbiological Stability

Microbiological testing assesses whether microorganisms grow within the product during storage or use. This is particularly important for water-based cosmetic formulations.

Testing may include:

• Microbial counts
• Preservative effectiveness
• Contamination monitoring

How Delta Performs Stability Testing

At Delta, stability testing services are designed to provide reliable data that supports both product development and regulatory submissions.

Protocol Development

Every stability study begins with a carefully designed stability testing protocol tailored to the product type and intended market.

This protocol typically defines:

• Testing duration
• Storage conditions
• Sampling intervals
• Analytical tests to be performed
• Acceptance criteria

By aligning protocols with regulatory expectations and product characteristics, Delta helps manufacturers generate meaningful and compliant stability data.

Temperature and Humidity Conditions

Environmental conditions play a major role in product stability. Testing commonly evaluates how formulations respond to different temperature and humidity levels over time.

Accelerated stability testing exposes products to elevated conditions to simulate the effects of time more quickly. This allows manufacturers to estimate shelf life before a full long-term study is complete.

In addition to temperature and humidity, Delta may also evaluate:

• Light exposure
• Freeze-thaw cycles
• Transport simulation

Stability Testing for Cosmetics and Pharmaceuticals

Different industries have specific regulatory expectations when it comes to stability testing.

Key Industry Standards

Cosmetic and pharmaceutical stability programs often follow internationally recognised guidelines such as:

• ICH stability guidelines for pharmaceuticals
• ISO cosmetic standards
• Regional regulatory frameworks for safety and labelling

While cosmetic regulations may not always mandate formal stability testing, most regulators expect brands to demonstrate that products remain safe and stable throughout their stated shelf life.

For pharmaceutical products, stability studies are typically required to support:

• Expiry dating
• Storage conditions
• Product registration

Working with an experienced laboratory helps ensure that testing programs meet relevant regulatory expectations.

Example Stability Considerations

Different product types can present unique stability challenges.

For example:

• Skincare emulsions may separate under heat stress.
• Active serums can lose potency over time if not stabilised properly.
• Pharmaceutical formulations may degrade chemically when exposed to humidity.

Stability testing helps identify these risks early so that formulations, packaging or storage instructions can be adjusted before market release.

Interpreting Stability Test Results

Collecting stability data is only part of the process. The results must be carefully analysed to determine whether a product meets its intended shelf life and quality specifications.

Data Reporting and Actions

At scheduled intervals during a stability study, samples are tested and the results are recorded. These data points help identify trends such as:

• Gradual ingredient degradation
• Changes in pH or viscosity
• Microbial growth
• Packaging interactions

Based on the results, manufacturers may take actions such as:

• Adjusting the formulation
• Modifying preservatives
• Selecting more suitable packaging
• Updating shelf-life claims

Clear and structured reporting helps R&D teams and regulatory professionals make informed decisions quickly.

Using both approaches together allows manufacturers to balance speed and scientific confidence when bringing products to market.

Why Choose Delta

Choosing the right laboratory partner is essential for reliable stability testing services.

Delta supports cosmetic, personal care and pharmaceutical manufacturers through:

• Accredited laboratory testing that meets recognised industry standards
• Tailored stability testing protocols aligned with product and regulatory requirements
• Accelerated and long-term stability studies to support product development timelines
• Clear reporting and expert guidance for interpreting results
• Responsive customer support to help teams move efficiently through testing and regulatory milestones

By combining scientific expertise with practical industry experience, Delta helps brands confidently validate product stability, protect consumer safety and support successful market launches.