Author: Stephanie Varchione

Cosmetic products are regulated differently depending on where they are sold. A product developed for Australia may need changes before it can be sold in the European Union or United States.

For brands planning to enter more than one market, it helps to understand these differences while the product is still being developed. Ingredients, claims, testing, labelling and documentation can all be affected by the intended market.

This guide looks at some of the main regulatory considerations for cosmetic products in Australia, the European Union and the United States.

Cosmetic Regulation in Australia

Australia does not have one regulator responsible for every aspect of a cosmetic product.

For many cosmetics, the Australian Industrial Chemicals Introduction Scheme, known as AICIS, regulates the industrial chemicals used as ingredients. Other requirements apply to areas such as ingredient labelling and products that fall within the therapeutic goods framework.

Whether a product is considered a cosmetic or therapeutic good can depend on what the product does, the ingredients it contains and the claims being made.

AICIS and Cosmetic Ingredients

AICIS regulates the importation and manufacture of industrial chemicals in Australia. Almost all ingredients used in skincare, personal care, make-up and other cosmetic products are considered industrial chemicals for these purposes.

AICIS does not approve finished cosmetic products. Instead, businesses importing or manufacturing relevant chemicals need to understand how those chemical introductions are authorised.

Depending on the ingredient and how it is introduced, this may involve checking its status on the Australian Inventory of Industrial Chemicals, determining the relevant introduction category and meeting any applicable reporting or record-keeping requirements.

For brands, the key point is that ingredient requirements need to be considered as part of product development, particularly when new or imported ingredients are involved.

Cosmetic or Therapeutic?

The claims made about a product can also affect how it is regulated.

A moisturiser positioned around hydration and maintaining the skin in good condition may be treated differently from a product making therapeutic claims.

This is important to consider before claims and marketing language are finalised. Changing how a product is presented can change the regulatory requirements that apply to it.

What Should Brands Consider in Australia?

For a cosmetic product intended for the Australian market, brands may need to consider:

• The AICIS status of relevant ingredients
• Whether registration or other AICIS obligations apply
• Product classification
• Ingredient labelling
• Claims and intended use
• Record-keeping requirements
• Whether another Australian regulatory framework applies

The pathway should be considered for the individual product rather than assuming all cosmetics follow exactly the same process.

Cosmetic Regulation in the European Union

Cosmetics sold in the European Union are regulated under Regulation (EC) No 1223/2009.

The EU framework places specific responsibilities on the person or business responsible for placing the product on the market. It also requires safety documentation to be completed before the product is sold.

The Responsible Person

Every cosmetic product placed on the EU market needs a designated Responsible Person based within the European Union.

The Responsible Person has defined responsibilities under the EU Cosmetics Regulation and is responsible for ensuring the relevant requirements for the product are met.

For an Australian brand entering the EU, identifying who will take on this role is an important part of planning the launch.

Cosmetic Product Safety Report

Before a cosmetic product is placed on the EU market, it needs to undergo a safety assessment and have a Cosmetic Product Safety Report, commonly called a CPSR.

The safety assessment must be completed by someone with the appropriate qualifications.

This means the safety assessment is not simply a document produced by the manufacturer at the end of development. The appropriate specialist needs to be involved as part of the EU market-entry process.

Product Information File

Each cosmetic product also requires a Product Information File, or PIF.

The PIF brings together information relating to the product, including its safety report, manufacturing information and other documentation required under the EU Cosmetics Regulation.

The Responsible Person is responsible for keeping the PIF available for the required period.

CPNP Notification

Before the product is placed on the EU market, it must also be notified through the Cosmetic Products Notification Portal, known as the CPNP.

The CPNP is a notification system. Notification does not mean that the product has been individually approved by the European Commission.

Planning for the EU

An Australian brand preparing a cosmetic product for the European Union will generally need to consider:

• Who will act as the EU Responsible Person
• Whether the formulation meets EU ingredient requirements
• The required safety assessment and CPSR
• The Product Information File
• Labelling and claims
• CPNP notification

These requirements are easier to address before the formulation and artwork have been completely finalised.

Cosmetic Regulation in the United States

Cosmetics in the United States are regulated by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act.

The Modernization of Cosmetics Regulation Act of 2022, known as MoCRA, also introduced additional requirements for the cosmetics industry.

The responsibilities that apply depend on the product and the businesses involved.

Facility Registration

Cosmetic manufacturing and processing facilities that fall within the MoCRA registration requirements need to register with the FDA and renew their registration every two years.

There are exemptions for some businesses and products, so the requirement should be confirmed for the individual situation.

Facility registration is not the same as FDA approval of the products manufactured at that facility.

Cosmetic Product Listing

MoCRA also introduced cosmetic product listing requirements.

The responsible person, generally the manufacturer, packer or distributor whose name appears on the product label, is responsible for listing marketed cosmetic products with the FDA where the requirement applies.

These listings need to contain specified information about the product and be updated as required.

Like facility registration, product listing should not be described as FDA product approval.

Safety Substantiation

The responsible person also needs to maintain records supporting adequate safety substantiation for the cosmetic products they market.

What is appropriate will depend on the product and the information available to support its safety.

This is one reason product documentation should be considered throughout development rather than assembled only when a product is ready to launch.

Other US Considerations

Brands planning to sell cosmetics in the United States may also need to consider:

• Ingredient requirements
• Colour additive requirements
• Labelling and claims
• Adverse event reporting obligations
• Facility registration, where applicable
• Cosmetic product listing, where applicable
• Safety substantiation records

The brand, manufacturer and any regulatory partners should be clear about who is responsible for each requirement.

How Do Australia, the EU and US Differ?

The three markets regulate cosmetics in different ways.

In Australia, AICIS regulates the introduction of many of the industrial chemicals used in cosmetics. Product classification and labelling also need to be considered separately.

In the European Union, cosmetic products need an EU-based Responsible Person, a safety assessment, a CPSR, a PIF and CPNP notification before being placed on the market.

In the United States, brands need to consider the requirements of the Federal Food, Drug, and Cosmetic Act and MoCRA. Depending on the product and business, this can include facility registration, product listing, safety substantiation and adverse event reporting.

These differences matter when a brand wants to use the same formulation in several markets.

An ingredient that can be used in one region may have different requirements in another. Claims and labelling may also need to change.

Can the Same Cosmetic Formula Be Sold in Multiple Markets?

Potentially, but it should not be assumed.

The formulation needs to be considered against the requirements of each intended market. This is particularly important for ingredients that are restricted, used at specific levels or treated differently between regions.

The claims made about the finished product also matter. A claim that is appropriate for a cosmetic in one market may create different regulatory considerations somewhere else.

Brands considering international expansion should make their intended markets clear while the product is still being developed.

This gives the formulation and manufacturing team more opportunity to identify requirements that could affect the finished product.

What About Product Testing?

Testing requirements depend on the type of cosmetic, the formulation and where the product will be sold.

Depending on the product, development may include:

• Stability testing
• Bacterial, yeast and mould testing
• Preservative efficacy testing

Other testing, documentation or specialist assessments may be needed for particular products or markets.

There is no single testing program that applies to every cosmetic product, so the appropriate requirements should be considered on a product-by-product basis.

When Should Regulatory Requirements Be Considered?

Ideally, brands should start thinking about their intended markets before the formulation, packaging and claims are locked in.

This does not mean every regulatory detail needs to be resolved before development begins.

It does mean the formulation and manufacturing team should know where the brand plans to sell the product.

For example, if a brand knows from the beginning that it wants to launch in Australia and later expand into the EU, that information can be considered when ingredients and product claims are being discussed.

It is much easier to review these areas while the product is still in development than once packaging has been ordered and artwork approved.

Delta’s Role in Product Development

Delta works with cosmetic and personal care brands from formulation development through to commercial manufacturing.

When the intended market is known, requirements that may affect the formulation, testing, packaging or manufacturing process can be considered during development.

Depending on the project, this may involve discussions around:

• Ingredient requirements
• Product classification
• Testing
• Claims
• Packaging and artwork
• Manufacturing requirements

Some regulatory activities require specialist regulatory providers or other parties outside Delta’s role as manufacturer.

For example, an EU safety assessment, Responsible Person services or market-specific regulatory submissions may need to be managed by the brand or an external regulatory specialist.

Establishing these responsibilities early helps everyone involved understand what needs to happen as the product progresses towards market.

FAQ: Cosmetic Regulatory Compliance

Are cosmetics regulated differently in Australia, the EU and US?

Yes. Each market has its own framework for cosmetics, with different requirements around ingredients, product documentation, labelling and market entry.

Does AICIS approve cosmetic products in Australia?

No. AICIS regulates the importation and manufacture of industrial chemicals, including almost all ingredients used in cosmetics. Finished cosmetic products are not approved by AICIS.

What does an Australian brand need to sell cosmetics in the EU?

EU cosmetics need to meet the requirements of the EU Cosmetics Regulation. This includes having an EU-based Responsible Person, completing the required safety assessment and CPSR, maintaining a PIF and notifying the product through the CPNP before it is placed on the market.

Does the FDA approve cosmetic products?

Cosmetic facility registration and product listing under MoCRA are not FDA product approval. Businesses still need to understand and meet the requirements that apply to their cosmetic products.

What is MoCRA?

MoCRA is the Modernization of Cosmetics Regulation Act of 2022. It introduced new requirements for the US cosmetics industry, including areas such as facility registration, product listing, safety substantiation and adverse event reporting.

When should brands start thinking about international requirements?

As early as practical. If a brand intends to enter several markets, sharing those plans during product development can help identify requirements that may affect the formulation, claims or packaging.

Planning a Product for More Than One Market?

Different markets can require different approaches to formulation, documentation, claims and labelling.

Knowing where you plan to sell your product early gives your formulation and manufacturing team useful context during development.

Delta works with cosmetic and personal care brands from initial formulation development through to commercial manufacturing.

Speak to Delta

Talk to Delta about your product, intended markets and manufacturing requirements.

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A cosmetic formulation lab is where product ideas are developed into formulas that can be sampled, tested and prepared for commercial manufacturing.

At Delta, formulation is considered as part of the wider product development and manufacturing process, alongside testing, scale-up and production requirements.

For founders and product developers in the early stages of creation, working with an experienced formulation and manufacturing partner can make the development process easier to navigate and help identify potential issues earlier.

What Is a Cosmetic Formulation Lab?

A cosmetic formulation lab is an R&D environment where cosmetic and personal care formulas are developed, sampled and refined before moving towards manufacturing.

This is where the product brief starts becoming a real formula that a brand can review and refine. In practical terms, a formulation lab helps answer some of the most important early-stage product questions:

• Which ingredients will deliver the desired benefit?
• Will the formula remain stable over time?
• Can the product be manufactured consistently at scale?
• Are there ingredient, claim or market requirements that need to be considered during development?

Put simply, formulation development takes a product idea and turns it into something that can be sampled, tested, refined and eventually manufactured at scale.

Why Formulation Matters to Product Success

Formulation is one of the most important stages in the product development lifecycle.

Good formulation work creates a stronger starting point for testing, scale-up and manufacturing. It allows areas such as product performance, consistency, stability and manufacturing requirements to be considered during development.

Inside the Delta Formulation Process

At Delta, formulation development is a collaborative process that takes both the product brief and future manufacturing requirements into account.

The aim is not just to create a good lab sample. The formula also needs to be suitable for testing, scale-up and eventual production.

Step 1: Understanding the Product Brief

Every successful formulation begins with a clear understanding of the product vision.

This early stage typically includes:

• Product type and format
• Performance goals and intended claims
• Texture and sensory targets
• Ingredient preferences or exclusions
• Packaging considerations
• Intended market and compliance requirements

A clear brief gives the formulation team a better understanding of what the finished product needs to achieve.

Step 2: Ingredient Research and Selection

Ingredient selection needs to consider more than what looks good on a product concept. Ingredients need to work together within the formula and also suit the product brief, intended claims, cost expectations and manufacturing process.

At this stage, formulation teams consider:

• The ingredients the brand wants to include or avoid
• The intended product benefits and claims
• Texture and sensory preferences
• Raw material availability and cost
• How the ingredients work together in the complete formula
• Requirements that may apply in the intended market

Ingredient decisions are made as part of the complete formulation rather than one ingredient at a time, taking into account the intended product experience and future testing requirements.

Step 3: Prototype Development

Once the initial ingredient direction is defined, the formulation team begins prototype development.

The formulation team then prepares an initial lab sample for the brand to review. Depending on the product and the feedback received, the formula may be adjusted several times before it is ready to move forward, adjustments may be to:

• Texture
• Appearance
• Fragrance
• Absorption or spreadability
• Overall product feel

Prototype development is rarely a one-step process. It usually involves several iterations, each informed by technical observations and client feedback.

At Delta, prototype work is approached with the end goal in mind: a product that not only performs well in the lab, but can also move successfully through testing and into production.

Testing, Stability and Compliance

Once a formulation has been approved at lab-sample stage, testing can provide more information about how it performs over time and whether any further adjustments are needed.

A lab sample can look and feel right when it is first made, but further testing is needed to understand how the product performs over time.

Performance and Shelf-Life Testing

Testing can provide information about how a formulation performs over time and whether further development work may be required.

The testing program will depend on the product. It may include stability testing and, where relevant:

• Bacterial, yeast and mould testing
• Preservative efficacy testing

The results can help determine whether the formulation can progress or whether further development work is required.

Considering Regulatory Requirements During Development

Regulatory requirements are best considered during development rather than after the formula has already been finalised.

What needs to be considered will depend on the type of product, its ingredients, the claims being made and where the brand intends to sell it.

This is particularly important because different products can follow different regulatory pathways. A standard cosmetic product and a product making therapeutic claims, for example, may not be treated in the same way.

From Lab to Manufacturing Scale

Moving from a small lab sample to a commercial manufacturing batch is an important stage of product development.

A common challenge in product development is that a formula performs well in a small laboratory batch but behaves differently during larger-scale manufacturing. A formulation produced at lab scale may need adjustments to the manufacturing process when it is produced using larger equipment and at higher volumes.

Transitioning from R&D to Production

Once the lab sample has been approved, the manufacturing process can be developed. Where required, a pilot-scale batch can also be used before the product progresses to commercial production.

Considering manufacturing requirements during development can make the transition from lab-scale formulation to commercial production more straightforward.

This is one of the advantages of working with a formulation and manufacturing partner that can consider commercial production during development.

How Delta Supports Cosmetic Formulation

Delta works with cosmetic and skincare brands across formulation development and commercial manufacturing, helping connect the early development stages with the requirements of production.

Having formulation and manufacturing capabilities connected within the same process means production requirements can be considered earlier in development.

Delta’s formulation support can include:

• Product brief and formulation development
• Lab samples and formulation refinement
• Testing planning
• Scale-up where required
• Commercial manufacturing, filling and packing

Strong Products Begin with the Right Formulation Partner

Creating a good lab sample is only one part of developing a commercial product. The formulation also needs to progress through the appropriate testing and be successfully transferred into manufacturing.

Considering manufacturing requirements during formulation can make the transition from development to production more straightforward.

Delta works with cosmetic and skincare brands from early formulation development through to commercial manufacturing.

Launching an SPF product introduces some considerations that brands may not encounter with a standard cosmetic product.

Before committing to a launch, brands need to understand the type of SPF product they want to create, the regulatory pathway that may apply, the claims they want to make and what will be involved in formulation, testing and commercial manufacturing.

Making these decisions early can give both the brand and manufacturing team a clearer direction for development.

This guide covers the key questions worth considering before starting an SPF project in Australia.

What Do Brands Need Before Launching Sunscreen?

A good SPF project starts with a clear brief and an understanding of what the brand wants to bring to market.

Before development begins, it helps to agree on the key commercial and product requirements so the formulation team has a clear starting point.

Brands should consider:

• The type of SPF product
• Target SPF
• Intended use and audience
• Desired texture and finish
• Intended claims
• Packaging direction
• Target cost
• Expected order volumes
• Intended launch timing

Not every detail needs to be finalised before speaking with a manufacturer. In fact, involving the formulation and manufacturing team early can help determine which parts of the original concept are practical and which may need further discussion.

How Are SPF Products Regulated in Australia?

In Australia, the regulatory pathway depends on the type of sunscreen, its intended purpose and how it is presented to consumers.

Primary sunscreens (products represented primarily as providing protection from UV radiation) are regulated by the Therapeutic Goods Administration (TGA) as therapeutic goods.

Some secondary sunscreen products are also regulated as therapeutic goods, while certain secondary sunscreens are excluded from therapeutic-goods legislation.

For a brand, understanding the likely pathway early is important because it can influence areas such as:

• Formulation
• Ingredients
• Testing
• Claims
• Labelling
• Manufacturing requirements

Brands should confirm the requirements that apply to their specific product rather than assuming all SPF products follow the same pathway.

Do All SPF Products Follow the Same Regulatory Pathway?

No. The regulatory pathway depends on how the product is intended to be used and marketed.

In Australia, primary sunscreens are regulated as therapeutic goods. Some secondary sunscreens are also regulated by the TGA, while certain secondary sunscreen products are excluded from therapeutic-goods legislation.

For example, the regulatory considerations for a product whose primary purpose is sun protection may differ from those for a cosmetic product that provides a secondary sunscreen benefit.

This is why brands should establish the intended use, SPF and claims early in development and confirm which requirements apply to the individual product.

What Testing Is Needed Before Selling Sunscreen?

The testing required will depend on the product, regulatory pathway and claims being made.

For SPF products, this may include testing to support the intended SPF and, where relevant, broad-spectrum or water-resistance claims.

Product development may also involve stability testing and, where relevant:

• Bacterial, yeast and mould testing
• Preservative efficacy testing

The appropriate testing pathway should be determined for the individual product rather than assuming every SPF product requires the same program.

Testing should also be allowed for in the development timeline, as results may identify that further formulation work is required.

The TGA specifically requires therapeutic sunscreen sponsors to hold evidence supporting their product and applicable claims.

Why Does SPF Need Its Own Development Process?

An SPF product needs to be developed with its intended protection, use and regulatory requirements in mind from the beginning.

The formulation team is not only considering how the product feels on the skin. They also need to work towards the intended SPF and other relevant product requirements while developing a formula that can progress through testing and commercial manufacturing.

For the brand, this can mean making trade-offs during development. A particular texture, finish, ingredient preference, claim or price point may need to be reconsidered as the formulation progresses.

This is why adding SPF to a range should be treated as its own product development project rather than simply adapting an existing skincare formula.

How Can Brands Differentiate an SPF Range?

Before developing an SPF product, brands should be clear on the role it will play within their range.

Differentiation does not necessarily need to come from adding more claims or ingredients. It may come from who the product is designed for, how it feels, when it is used or how it fits into the wider brand.

Brands might consider:

• Who the product is for
• Whether it is designed for face, body or a particular use
• Desired texture and finish
• Tinted or untinted formats
• How it fits into an existing skincare routine
• Price and retail positioning
• Packaging and overall brand experience

The key is to give the product a clear reason to exist while allowing the formulation team enough flexibility to develop it appropriately.

What Claims Should SPF Brands Be Careful With?

Claims should be considered early because they can affect both the product development and regulatory pathway.

For SPF products, particular care should be taken with claims relating to areas such as:

• SPF and UV protection
• Water resistance
• Duration of protection
• Intended users
• Product performance
• Therapeutic benefits

Brands should also avoid finalising packaging or campaign language before understanding what evidence may be required to support the claims being made.

Claims used across packaging, websites, advertising and retailer materials should accurately reflect the finished product and the evidence held to support it.

What Should Brands Plan for Before Manufacturing?

An approved formulation is not the final step before launch. Brands also need to plan for commercial production.

This can include:

• Raw material availability
• Packaging supply
• Order quantities
• Manufacturing lead times
• Filling requirements
• Production scheduling
• Finished goods and freight planning

These considerations become particularly important when a brand is working towards retailer deadlines or coordinating a product launch across marketing, warehousing and distribution.

Discussing commercial requirements with the manufacturer early gives the brand a more realistic view of what needs to happen before production can begin.

How Long Does an SPF Product Launch Take?

There is no single timeline for developing and launching an SPF product.

Timing can depend on:

• The formulation
• Regulatory pathway
• Required testing
• Packaging
• Availability of raw materials and components
• Manufacturing requirements
• Whether further development or testing is needed

For brands working towards a particular launch or retail date, these stages should be factored into planning before committing to campaign or stock deadlines.

It is also sensible to allow some flexibility in the timeline rather than assuming the first formulation or testing round will be the final one.

SPF Range Launch Checklist

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

Before progressing with an SPF range, ask:

• Have we clearly defined the product?
• Do we understand the likely regulatory pathway?
• Are our intended claims clear?
• Have we allowed for the required testing?
• Have we involved our manufacturer early enough?
• Is our packaging direction suitable for the product?
• Is our target cost realistic?
• Have we considered production volumes and lead times?
• Is our launch timeline flexible enough to accommodate development?
• Does the product have a clear role within our range?

You don’t need to have every answer before approaching a manufacturer. These questions are intended to help identify what has been decided and where further guidance may be needed.

Decisions Worth Making Early

Some decisions become much harder or more expensive to change later in development.

Before committing to packaging, artwork or launch dates, it is useful to have clarity around:

• The intended product and claims
• The regulatory pathway
• What testing may be required
• Packaging direction
• Target cost and order volumes
• Manufacturing requirements
• A realistic development timeline

Not all of these decisions need to be made by the brand alone. An experienced formulation and manufacturing partner can help identify what needs to be decided early and what can remain flexible as the product develops.

How Delta Supports SPF Range Development

Delta works with skincare and personal care brands across SPF formulation development and commercial manufacturing.

Delta operates TGA-licensed manufacturing facilities in Australia, supporting the manufacture of sunscreen and SPF products within regulated manufacturing environments.

Depending on the project, Delta can support brands through formulation development and refinement, stability testing, planning for required SPF testing, manufacturing scale-up and commercial production.

Working with the manufacturing team early also means commercial considerations such as production volumes, packaging, timelines and future scale can be discussed while the product is still being developed.

FAQs About Launching an SPF Range

What Do Brands Need Before Launching Sunscreen?

A useful starting point is a clear product brief covering the type of SPF product, intended claims, desired product experience, packaging direction, commercial requirements and launch goals. The regulatory and testing pathway can then be determined as the project develops.

How Are SPF Products Regulated in Australia?

Primary sunscreens and some secondary sunscreens are regulated by the TGA as therapeutic goods. Certain secondary sunscreen products are excluded from therapeutic-goods legislation. The pathway depends on the individual product, its intended use and how it is presented.

What Testing Is Needed Before Selling Sunscreen?

Testing depends on the product and claims. It may include testing to support SPF, broad-spectrum or water-resistance claims where relevant, alongside stability and other product testing appropriate to the formulation.

Can an Existing Skincare Brand Add SPF to Its Range?

Yes. An existing skincare brand can develop an SPF product, but it should be treated as its own development project. The regulatory pathway, formulation, testing, claims and manufacturing requirements need to be considered for the individual product.

Why should brands allow flexibility in an SPF development timeline?

SPF development can involve formulation refinement, testing, regulatory requirements, packaging and manufacturing stages. If further formulation work or testing is needed, the original timeline may need to change.

What Should Brands Ask an SPF Manufacturer?

Ask about their experience with SPF products, formulation capabilities, manufacturing licences and quality systems, how required testing is coordinated, commercial production capability and when they recommend involving packaging.

Planning an SPF Range?

Launching an SPF product involves decisions across formulation, regulation, testing, packaging and commercial manufacturing.

Understanding these requirements early can help brands develop a clearer brief and make more informed decisions before committing to packaging, claims or launch timing.

Delta works with skincare and personal care brands across SPF formulation development and commercial manufacturing in Australia.

Planning an SPF product?

Speak to Delta about your product brief and the next steps towards commercial manufacturing.

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Developing a therapeutic product in Australia involves different manufacturing requirements from developing a standard cosmetic product.

For brands entering categories such as therapeutic sunscreen, this can mean working within Good Manufacturing Practice (GMP) requirements, maintaining appropriate documentation and understanding the responsibilities of the brand, sponsor and manufacturer.

Working with a TGA-licensed manufacturer gives brands access to manufacturing systems and processes designed for regulated therapeutic goods.

This guide explains what that means in practice and what brands should understand before moving into production.

What Is a TGA-Listed Product?

A listed therapeutic good is a product included in the Australian Register of Therapeutic Goods (ARTG) through the listed medicines pathway.

Listed medicines carry an AUST L number on their label. Some sunscreens are supplied through this pathway, alongside other types of listed medicines.

Being listed is not simply a labelling step. The sponsor of the product has responsibilities relating to areas such as ingredients, claims, evidence, manufacturing and ongoing compliance.

For brands considering a therapeutic product, the regulatory pathway should therefore be understood before formulation, claims, packaging and launch plans are finalised.

Sunscreens as Therapeutic Goods in Australia

In Australia, primary sunscreens and some secondary sunscreens are regulated by the TGA as therapeutic goods.

Primary sunscreens are products represented as being primarily for protection from UV radiation. Some secondary sunscreens are also therapeutic goods, while certain secondary sunscreen products are excluded from therapeutic-goods legislation.

Therapeutic sunscreens generally need to be included in the ARTG before they can be legally supplied in Australia.

For listed therapeutic sunscreens, requirements apply to areas such as permitted ingredients and indications, testing, labelling and manufacture in an appropriate TGA-approved facility.

Brands should confirm which pathway applies to their specific product rather than assuming all SPF products are regulated in the same way.

Why Product Classification Matters

Whether a product is regulated as a cosmetic or therapeutic good depends on factors including its intended purpose, ingredients, presentation and claims.

This distinction is important because therapeutic goods can have different requirements around manufacture, evidence, labelling and supply.

For brands, this means claims should not be developed in isolation from the product itself. A marketing direction that changes how a product is represented may also affect the regulatory considerations that need to be addressed.

Understanding the intended product and its regulatory pathway early gives the brand and manufacturing team a clearer basis for development.

What to Expect From a TGA-Licensed Manufacturer

Australian manufacturers of therapeutic goods may need to hold a TGA manufacturing licence for the relevant manufacturing activities.

For brands, working with a licensed manufacturer means production takes place within defined manufacturing and quality systems applicable to the therapeutic goods being made.

The manufacturer’s role and the sponsor’s role are not the same, so responsibilities should be understood at the beginning of the project.

What Does GMP Mean?

GMP stands for Good Manufacturing Practice.

For therapeutic sunscreens, manufacturers must operate in accordance with applicable GMP requirements. These requirements cover how therapeutic goods are manufactured, controlled, documented and released.

For a brand, the important point is that manufacturing is carried out within documented systems designed to support consistent production and product quality.

Documentation and Quality Systems

Documentation is an important part of regulated manufacturing because it provides a record of the product and how it was manufactured.

The exact documentation will depend on the product, regulatory pathway and responsibilities of the manufacturer and sponsor.

Depending on the project, manufacturing records may include areas such as:

• Approved formulation and specifications
• Raw material information
• Manufacturing instructions
• Batch manufacturing records
• Quality control records
• Relevant testing documentation
• Packaging specifications
• Batch release documentation

Brands should discuss documentation requirements with their manufacturer early so there is a clear understanding of what each party is responsible for maintaining.

Batch Traceability and Quality Assurance

Batch traceability creates a record of the materials and manufacturing activities associated with each production batch.

In a regulated manufacturing environment, batch documentation allows relevant information to be reviewed if a question or quality issue arises.

Quality systems also support the review and release of manufactured batches against the applicable requirements and finished product specifications.

For brands, this is one of the practical differences they may notice when moving from standard cosmetic production into a regulated therapeutic category.

The Role of Testing

Testing requirements depend on the product, regulatory pathway and claims being made.

For therapeutic sunscreens, evidence is required to support the SPF and other applicable sunscreen claims.

Depending on the product, this may include:

• SPF testing
• Broad-spectrum testing
• Water-resistance testing, where relevant

The sponsor of a listed therapeutic sunscreen is responsible for holding evidence demonstrating that the product meets applicable requirements.

Testing requirements should be considered during development so the brand understands what needs to be completed before the product can progress to market.

Stability and Microbiological Testing

Stability testing provides information about how a formulation performs over time under defined storage conditions.

The testing program will depend on the product and stage of development.

Testing may also include:

• Bacterial, yeast and mould testing
• Preservative efficacy testing

The results can help identify whether further formulation work may be required before the product progresses through development.

Packaging should also be considered during product development so the intended pack can be assessed alongside the formulation.

Questions Brands Should Ask Potential Manufacturers

When speaking with a potential manufacturing partner, brands may want to ask:

• Does your TGA licence cover the type of product we want to manufacture?
• What experience do you have with this product category?
• Can you support formulation development where required?
• What manufacturing documentation will be provided?
• How are testing requirements coordinated?
• What responsibilities sit with the manufacturer and what sits with the sponsor?
• What batch sizes can you manufacture?
• What should we understand about scale-up and production planning?
• When should packaging be introduced into the development process?

What Should Brands Resolve Early?

Entering a regulated product category can introduce requirements that a brand may not have encountered with standard cosmetic manufacturing.

Before committing to packaging, artwork or launch dates, brands should have a clear understanding of:

• The regulatory pathway
• Intended claims
• Testing requirements
• Manufacturing responsibilities
• Packaging direction
• Production quantities
• Development and manufacturing timelines

Not every decision needs to be made by the brand alone. Speaking with the manufacturer early can help clarify what needs to be resolved before production and what can continue to develop as the project progresses.

TGA-Licensed Manufacturing at Delta

Delta operates TGA-licensed manufacturing facilities in Australia, supporting the manufacture of regulated therapeutic products including listed sunscreen products.

Delta’s manufacturing licence supports relevant manufacturing activities for liquids and semi-solids, including listed therapeutic sunscreen products.

For brands, Delta can support the manufacturing journey from formulation development and scale-up through to commercial production within its licensed manufacturing environment.

Where regulatory or testing requirements sit outside Delta’s role as manufacturer, responsibilities should be established with the brand or product sponsor as part of the development process.

FAQs

What Is a TGA-Listed Sunscreen?

A listed therapeutic sunscreen is a sunscreen included in the Australian Register of Therapeutic Goods through the listed medicines pathway. Listed medicines carry an AUST L number on their label.

What Does GMP Manufacturing Mean?

GMP stands for Good Manufacturing Practice. Therapeutic sunscreens must be manufactured in accordance with applicable GMP requirements, which govern how therapeutic goods are manufactured and controlled.

What Is the Manufacturer Responsible For?

The manufacturer’s responsibilities depend on the manufacturing activities they perform and the applicable product requirements. These can include manufacturing within an appropriate licensed environment, following documented processes and maintaining required manufacturing and quality records. The sponsor also has separate regulatory responsibilities.

What Documentation Is Needed?

Documentation requirements depend on the product and regulatory pathway. Manufacturing records may include approved specifications, manufacturing instructions, batch records, quality records and relevant testing and release documentation.

Is TGA-Listed Sunscreen Manufacturing Different From Cosmetic Manufacturing?

Yes. Therapeutic sunscreens are manufactured within the regulatory framework for therapeutic goods and must meet applicable GMP requirements.

When Should a Brand Speak to a Manufacturer?

Ideally, before the product brief, packaging, claims and launch timing have been completely locked in. Early discussions can help clarify manufacturing requirements and responsibilities.

Planning a TGA-Regulated Product?

Working with a TGA-licensed manufacturer introduces manufacturing and documentation requirements that brands may not encounter with standard cosmetic production.

Understanding the product’s regulatory pathway and involving the appropriate manufacturing team early can help clarify what will be required as the project moves from development into commercial production.

Delta operates TGA-licensed manufacturing facilities in Australia and supports brands across regulated sunscreen and therapeutic product manufacturing.

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Developing an SPF product involves more than creating a formula that feels good on the skin. Brands also need to consider how the product will be regulated, what claims they want to make, the testing required to support those claims, packaging and how the formula will move into commercial manufacturing.

The process generally starts with a clear product brief, followed by formulation development and refinement. From there, the product progresses through the appropriate testing and regulatory requirements before packaging is finalised and manufacturing begins.

A typical SPF development process includes:

1. Defining the product concept, target SPF and intended claims
2. Understanding the regulatory pathway
3. Developing and refining the formulation
4. Reviewing lab samples and making adjustments
5. Completing the required stability and product testing
6. Completing SPF, broad-spectrum and other relevant claims testing
7. Finalising packaging and artwork
8. Scaling the formulation for commercial manufacturing
9. Completing manufacturing and quality requirements
10. Preparing the finished product for market

For brands developing SPF products in Australia, involving an experienced formulation and manufacturing partner early can make the process easier to navigate. It allows formulation, testing, regulatory and manufacturing considerations to be addressed before decisions around packaging, claims or launch timing become difficult to change.

What Is SPF Product Development?

SPF product development is the process of taking a sunscreen idea from an initial brief through formulation, testing and commercial manufacturing.

For a brand, this means working through what the product should be, how it should feel, the claims it will make, the regulatory pathway it falls under and what is required to manufacture it commercially.

The process starts with a clear brief. Before formulation begins, the development team needs to understand the type of SPF product the brand wants to create, who it is for, the desired texture and finish, intended claims, packaging direction and commercial goals.

Step 1: Define the SPF Product Concept

The first step is deciding what you are actually trying to create.

A daily facial SPF will have a different brief from a water-resistant body sunscreen or tinted SPF. Before formulation begins, the brand and development team should be clear on the product type, target SPF, desired texture and finish, intended claims, packaging direction, target cost and launch goals.

A strong SPF brief should include:

• Product type and format
• Target SPF
• Desired texture and finish
• Intended claims
• Packaging direction
• Target cost
• Expected order volume
• Launch timing

A clear brief gives the formulation team a better starting point for development.

Step 2: Confirm the Regulatory Pathway

In Australia, the regulatory pathway depends on the type of sunscreen and how the product is intended to be used and marketed.

Sunscreen products do not all follow the same pathway. Depending on the product, its intended use and the claims being made, different regulatory requirements may apply.

Understanding this early can help inform decisions around formulation, testing, claims and artwork before those elements are finalised.

Brands should consider:

• How the product will be classified
• What requirements apply to the intended product
• What claims the brand intends to make
• What testing or evidence may be required
• What labelling requirements apply

For brands planning to sell in more than one market, requirements should also be considered for each intended region. A product developed for Australia may not necessarily follow the same pathway in another market.

Step 3: Build the Sunscreen Formulation Strategy

SPF formulation involves balancing the protection target with how the product needs to feel and perform in use.

The formulation team works from the product brief to develop a formula that takes into account the intended SPF, product format, texture and finish, ingredient requirements, stability, cost and future manufacturing.

These decisions need to be considered together. Changing one part of a formulation can affect other aspects of the finished product, which is why SPF development often involves testing and refinement rather than a single formulation attempt.

For brands, the focus should be on clearly communicating what the finished product needs to achieve rather than trying to specify every technical element of the formulation.

Step 4: Choose the Right UV Filter Approach

UV filters are the active ingredients responsible for a sunscreen’s UV protection.

The appropriate filter system will depend on the product being developed, the intended SPF, the desired product format and the regulatory requirements that apply.

Rather than selecting UV filters based on marketing preference alone, brands are generally better placed to start by defining the type of product they want to create, including its intended use, texture, finish and claims.

The formulation team can then determine an appropriate approach within the technical and regulatory requirements of the product.

Step 5: Develop and Refine Prototypes

Once the formulation direction has been established, the formulation team can prepare an initial lab sample for review.

The brand can then assess the sample and provide feedback before the formulation moves forward.

Feedback may relate to:

• Texture
• Spreadability
• Finish
• Fragrance
• White cast or transparency
• How the product feels on the skin

Several rounds of refinement may be required before the formulation is approved to move into the next stage of development.

Clear feedback helps the formulation team understand what needs to change between samples and keeps the development process moving in the right direction.

Step 6: Complete Stability Testing

Stability testing provides information about how a formulation performs over time under defined storage conditions.

Once a formulation reaches the appropriate stage of development, stability testing can be used to monitor changes in the product and identify whether further development work may be required.

The testing program will depend on the product and stage of development.

Testing may also include:

• Bacterial, yeast and mould testing
• Preservative efficacy testing

Packaging should also be considered during development so the intended pack can be assessed alongside the formulation before commercial production.

The results from testing can help determine whether the product is ready to continue through development or whether adjustments are required.

Step 7: Complete SPF and Performance Testing

SPF testing is used to determine whether the product supports the SPF it is intended to claim.

Depending on the product and its intended claims, additional testing may also be required.

This may include:

• SPF testing
• Broad-spectrum testing
• Water-resistance testing, where relevant

The testing pathway will depend on the product and claims being made.

If testing shows that the product does not support the intended SPF or claim, further formulation work and testing may be required. This is one reason testing requirements should be considered during development rather than only at the end of the project.

Step 8: Finalise Packaging and Artwork

Packaging needs to be considered alongside the formulation rather than as a purely visual decision.

The chosen packaging format needs to suit the product, filling process and intended use while also providing enough space for the required product information.

Packaging considerations may include:

• Packaging format
• Fill volume
• Dispensing method
• Compatibility with the formulation
• Decoration and artwork requirements
• Space for required labelling

Artwork should also be reviewed before printing to make sure the required product information and claims are presented appropriately.

For SPF products, brands should take particular care with claims and on-pack wording, as these need to align with the requirements that apply to the product.

Step 9: Scale Up to Manufacturing

Once the formulation is ready to move beyond the lab, it needs to be translated into a commercial manufacturing process.

A small lab sample and a commercial batch are produced using different equipment and at very different volumes.

During scale-up, the manufacturing team establishes how the formulation will be produced consistently at commercial scale. The manufacturing process may need to be refined before the product moves into routine production.

Depending on the project, this may include reviewing the manufacturing method, batch size, processing requirements, filling process and finished product specifications.

Planning for scale-up during development helps make the transition from formulation into commercial manufacturing more straightforward.

Step 10: Prepare for Commercial Launch

Before commercial production and launch, the key product requirements should be resolved.

This includes the formulation, required testing, regulatory pathway, packaging, artwork and manufacturing requirements.

Before launch, brands should confirm:

• The final formulation is approved
• Required testing has been completed
• Claims are supported
• Packaging and artwork are finalised
• Manufacturing requirements are confirmed
• Regulatory obligations have been addressed

Brands should also allow enough time for production planning, packaging supply and any development or testing work that remains outstanding.

How Long Does SPF Product Development Take?

There is no single development timeline for an SPF product.

Timing will depend on the formulation, regulatory pathway, required testing, packaging and whether further development work is required following testing.

SPF projects can involve additional development, testing and regulatory stages compared with some cosmetic products, so brands should factor these into launch planning from the beginning.

It is also useful to allow some flexibility in the development timeline in case a formulation needs further refinement or testing needs to be repeated.

Can Cosmetic Brands Create Custom Sunscreen Formulas?

Yes. Brands can develop custom SPF formulations, although the available options will depend on the product brief, regulatory pathway and testing requirements.

Custom development can give brands greater control over areas such as the product format, texture, finish and positioning.

However, some elements of the original brief may need to change as technical and regulatory requirements become clearer during development.

A good development process helps the brand understand where there is flexibility and where technical or regulatory requirements need to take priority.

Common SPF Development Challenges

SPF development often involves balancing several priorities at once.

A brand may want a high level of protection, a particular skin feel, specific claims, preferred ingredients, certain packaging and a target cost.

Not every requirement will necessarily work together exactly as originally imagined.

Discussing priorities early helps the formulation team understand which parts of the brief are essential and where there may be room to adjust.

It can also prevent important product decisions from being made too late in the development process.

Choosing an SPF Manufacturer in Australia

For an SPF project, it is important to work with a manufacturer that understands both sunscreen development and commercial manufacturing.

Brands should understand the manufacturer’s experience with SPF products, manufacturing capabilities, quality systems and how the development and testing process will be managed.

When speaking with a potential SPF manufacturer, consider asking:

• What experience do you have manufacturing SPF products?
• Can you support formulation development?
• How is required testing coordinated?
• What quality systems apply to SPF manufacturing?
• Can you support scale-up and commercial production?
• At what stage should packaging be introduced?

These conversations can help a brand understand the development process before committing to packaging, claims or launch dates.

How Delta Supports SPF Product Development

Delta works with skincare and personal care brands across SPF formulation development and commercial manufacturing.

Depending on the project, Delta can support brands through formulation development and refinement, stability testing, planning for required SPF testing, manufacturing scale-up and commercial production.

Connecting formulation and manufacturing within the same development process also means commercial production requirements can be considered earlier rather than being introduced only after the formula has been completed.

For brands, this creates a clearer path from the initial product brief through to manufacturing.

FAQ: SPF Product Development

How do you develop an SPF product?

SPF development generally starts with a clear product brief, followed by understanding the regulatory pathway, formulation development, testing, scale-up and commercial manufacturing.

What testing is required for sunscreen in Australia?

Testing requirements depend on the type of sunscreen and the claims being made. This may include SPF, broad-spectrum and water-resistance testing where relevant, alongside other testing required for the individual formulation.

How long does SPF development take?

There is no standard development timeline. Timing depends on the formulation, testing requirements, regulatory pathway, packaging and whether further development work is required.

Can cosmetic brands create custom sunscreen formulas?

Yes. Custom SPF development is possible, although the formulation needs to work within the technical, testing and regulatory requirements that apply to the product.

What is a TGA-listed sunscreen?

A TGA-listed sunscreen is a therapeutic sunscreen included in the Australian Register of Therapeutic Goods and identified by an AUST L number. Specific requirements apply to the ingredients, claims, evidence and labelling of listed sunscreen products.

What makes SPF formulation difficult?

SPF formulation involves balancing the required protection with factors such as product format, texture, finish, stability and manufacturing requirements. Changes made to one part of the formulation can also affect other aspects of the product.

When should brands speak to an SPF manufacturer?

Ideally, early in the development process, before claims, packaging and launch dates have been finalised.

Developing an SPF Product Starts With the Right Partner

Developing an SPF product involves formulation, testing, regulatory and manufacturing decisions that are best considered together.

For brands developing sunscreen in Australia, involving an experienced SPF manufacturer early can make it easier to understand the process and plan the path from the initial product brief through to commercial production.

Delta works with skincare and personal care brands across SPF formulation development, scale-up and manufacturing.