Sunscreen products are regulated differently depending on where they are sold.
A product developed for Australia may not meet the requirements of the United States or European Union without further review. Each market has its own rules around sunscreen ingredients, testing, claims, labelling and market entry.
For brands considering more than one market, it is worth understanding these differences early. Decisions made during formulation can affect where the finished product can be sold and what changes may be needed later.
This guide covers some of the main SPF regulatory considerations in Australia, the United States and European Union.
Why Do Sunscreen Regulations Differ Between Markets?
Sunscreens do not fall into the same regulatory category around the world.
In Australia, primary sunscreens and some secondary sunscreens are regulated as therapeutic goods.
In the United States, sunscreens are regulated as over-the-counter drug products.
In the European Union, sunscreens are regulated as cosmetic products.
The way a sunscreen is classified affects areas such as the UV filters that can be used, testing, claims, labelling and manufacturing requirements.
A sunscreen developed for one country should therefore be reviewed before it is introduced into another market.
Sunscreen Regulations in Australia
In Australia, the regulatory pathway depends on the type of sunscreen, what the product is intended to do and how it is presented to consumers.
The Therapeutic Goods Administration, or TGA, regulates sunscreens that fall within the therapeutic goods framework.
Primary and Secondary Sunscreens
A primary sunscreen is a product whose main purpose is protection from UV radiation.
A secondary sunscreen has another main purpose but also provides sun protection. Depending on the product, SPF and claims, some secondary sunscreens are regulated as therapeutic goods while others are excluded from therapeutic goods legislation.
For brands, this distinction matters because the requirements are not the same for every product containing SPF.
The regulatory pathway should be confirmed for the individual product before claims, artwork or launch plans are finalised.
Therapeutic Sunscreens and the ARTG
Therapeutic sunscreens generally need to be included in the Australian Register of Therapeutic Goods, known as the ARTG, before they can be legally supplied in Australia.
Most therapeutic sunscreens are listed medicines and carry an AUST L number on the label.
Listed therapeutic sunscreens need to meet the requirements that apply to the product. These may relate to:
- Permitted ingredients
- Claims and indications
- Manufacturing
- Testing
- Labelling
- Supporting evidence
The sponsor of a listed sunscreen is responsible for ensuring the product meets the relevant requirements and for holding the evidence needed to support it.
Australian Sunscreen Testing
The testing required will depend on the product and the claims being made.
For therapeutic sunscreens, this may include:
- SPF testing
- Broad-spectrum testing
- Water-resistance testing, where relevant
The sponsor needs to hold appropriate evidence for the SPF and other applicable claims made for the product.
Australian Sunscreen Labelling
Therapeutic sunscreen labels also need to meet applicable Australian requirements.
Depending on the product, the label may need to include information relating to:
- SPF
- Broad-spectrum protection
- Active ingredients
- Directions for use
- Required warnings
- Storage conditions
- Expiry
- ARTG identification
Packaging and artwork should be considered alongside the regulatory pathway so required information can be incorporated before printing.
Sunscreen Regulations in the United States
In the United States, sunscreens are regulated by the Food and Drug Administration, or FDA, as over-the-counter drug products.
Sunscreen products marketed under the applicable over-the-counter framework need to meet FDA requirements relating to areas such as active ingredients, testing, claims and labelling.
UV Filters in the United States
The FDA specifies which sunscreen active ingredients can be used under the applicable over-the-counter framework and the conditions that apply to their use.
These requirements are not the same as those in Australia or the European Union.
If a brand intends to sell the same product in several markets, the proposed UV filter system should be reviewed for each region during formulation development.
SPF and Broad-Spectrum Claims
Sunscreen products sold in the United States need testing to support the SPF being claimed.
Products using a Broad Spectrum claim also need to meet the applicable FDA broad-spectrum requirements.
The claims available to the brand will depend on the product and the testing results.
Water-Resistance Claims
The FDA sets specific requirements for water-resistance claims.
Where supported by the required testing, products may use claims such as:
- Water resistant (40 minutes)
- Water resistant (80 minutes)
Claims such as waterproof, sweatproof and sunblock are not permitted under the FDA sunscreen framework.
Drug Facts Labelling
US sunscreen products use the Drug Facts format required for applicable over-the-counter medicines.
This includes information such as:
- Active ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other required product information
For Australian brands entering the US market, this can have a significant impact on packaging and artwork because the label format differs from what is used for cosmetic products in other regions.
Sunscreen Regulations in the European Union
In the European Union, sunscreen products are regulated as cosmetics under Regulation (EC) No 1223/2009.
The regulatory pathway is different from Australia and the United States, but sunscreen products still need to meet requirements relating to formulation, safety, documentation, claims and labelling.
UV Filters in the EU
The EU Cosmetics Regulation sets out which UV filters can be used in cosmetic products and the conditions that apply to their use.
A UV filter system developed for another market should therefore be checked against EU requirements before the product is finalised.
This is particularly relevant for brands hoping to use one formulation across several regions.
EU Cosmetic Product Requirements
Sunscreens sold in the European Union are also subject to the broader requirements that apply to cosmetic products.
These include:
- An EU-based Responsible Person
- A cosmetic product safety assessment
- A Cosmetic Product Safety Report
- A Product Information File
- Appropriate labelling
- Notification through the Cosmetic Products Notification Portal before the product is placed on the market
Brands based outside the EU will need to establish who will act as the Responsible Person as part of their market-entry planning.
UVA and UVB Protection
European Commission guidance recommends that sunscreen products provide protection against both UVB and UVA radiation.
The recommended minimum UVA protection factor is at least one-third of the claimed SPF. A critical wavelength of at least 370 nm is also part of the recommended approach.
For brands, this means the SPF number is only one part of the overall protection profile that needs to be considered.
Sunscreen Claims in the EU
Sunscreen claims need to reflect the protection provided by the product and the evidence available to support them.
European guidance advises against claims that suggest complete protection from UV radiation or imply that sunscreen does not need to be reapplied.
Claims, directions and warnings should be reviewed as part of product development rather than added once the formulation is complete.
How Do Australia, the US and EU Differ?
The biggest difference between these markets is how sunscreen is regulated.
In Australia, primary sunscreens and some secondary sunscreens fall within the therapeutic goods framework. Therapeutic sunscreens generally require ARTG inclusion and need to meet applicable requirements for ingredients, manufacture, testing, evidence and labelling.
In the United States, sunscreens are regulated as over-the-counter drugs. Products need to meet applicable FDA requirements for active ingredients, testing, claims and Drug Facts labelling.
In the European Union, sunscreens are regulated as cosmetic products. Brands need to consider permitted UV filters, safety assessment, product documentation, Responsible Person obligations, notification and labelling.
A formulation that works in one market may need to be reviewed or changed before it can be supplied in another.
Can the Same SPF Formula Be Sold in Multiple Markets?
It may be possible, but it should be considered during development.
Markets can differ in the UV filters and concentrations they allow, how sunscreens are classified, the testing required and the claims that can be made.
Labelling and documentation requirements can also vary.
If international expansion is part of the plan, brands should tell their formulation and manufacturing team which markets are being considered at the beginning of the project.
This gives the team an opportunity to identify potential differences while the formulation is still being developed.
What Testing Should Brands Consider?
There is no single testing program that applies to every sunscreen in every market.
Testing depends on the product, the claims being made and where it will be sold.
Depending on those requirements, testing may include:
- SPF testing
- Broad-spectrum or UVA testing
- Water-resistance testing, where relevant
- Stability testing
Product development may also include:
- Bacterial, yeast and mould testing
- Preservative efficacy testing
Brands should confirm the testing requirements for their individual product and intended market rather than assuming one testing pathway will cover every region.
Planning an SPF Product for More Than One Market
Brands considering more than one country should start by being clear about where the product is likely to be sold.
Useful questions to discuss early include:
- Which markets are being considered?
- What type of SPF product is being developed?
- What SPF does the brand want to achieve?
- What claims are planned?
- Are the proposed UV filters suitable for each market?
- What testing will be required?
- Will different packaging or artwork be needed?
- Who will manage regulatory submissions or notifications?
- What manufacturing requirements apply?
A brand does not need to have every answer before formulation begins. What matters is making the intended markets known early enough for them to be considered during development.
SPF Product Development at Delta
Delta works with skincare and personal care brands across SPF formulation development and commercial manufacturing in Australia.
When the intended markets are known early, the formulation and manufacturing teams can consider requirements that may affect the product as it develops.
Depending on the project, Delta can support:
- SPF formulation development and refinement
- Lab samples and product development
- Stability testing
- Planning for required external SPF testing
- Manufacturing scale-up
- Commercial manufacturing
Some regulatory activities and specialised testing may sit outside Delta’s role as manufacturer. Where this is the case, responsibilities should be agreed between the brand, sponsor and relevant regulatory or testing partners during development.
FAQ: SPF Regulations
Are sunscreens regulated differently in Australia, the US and EU?
Yes. Australia regulates primary sunscreens and some secondary sunscreens as therapeutic goods. The United States regulates sunscreens as over-the-counter drug products. The European Union regulates sunscreens as cosmetic products.
Do all Australian SPF products need to be listed with the TGA?
No. Primary sunscreens and some secondary sunscreens are therapeutic goods, while certain secondary sunscreen products are excluded from therapeutic goods legislation. The pathway depends on the individual product, its SPF, intended use and claims.
What testing is required for sunscreen in Australia?
The testing required depends on the product and claims being made. For therapeutic sunscreens, this may include SPF and broad-spectrum testing and water-resistance testing where relevant. The sponsor needs to hold appropriate evidence for the claims made.
How are sunscreens regulated in the United States?
Sunscreens are regulated by the FDA as over-the-counter drug products. Products marketed under the applicable sunscreen framework need to meet requirements relating to active ingredients, testing, claims and labelling.
How are sunscreens regulated in the European Union?
Sunscreens are regulated as cosmetic products under the EU Cosmetics Regulation. Requirements include permitted UV filters, product safety assessment and documentation, an EU Responsible Person, product notification and appropriate labelling and claims.
Can the same sunscreen formula be launched in several countries?
Potentially. However, ingredients, testing, claims, documentation and labelling requirements differ between markets. The intended regions should be considered during formulation development.
Developing SPF for More Than One Market?
Selling sunscreen internationally involves more than changing the label for a different country.
The formulation, testing, claims, packaging and regulatory pathway may all need to be reviewed for each market.
For brands considering Australia and future international expansion, discussing intended markets early gives the formulation and manufacturing team a clearer picture of the product being developed.
Planning an SPF Product?
Speak to Delta about your product brief, intended markets and commercial manufacturing requirements.