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We regulate sunscreens in Australia that are classified as therapeutic goods (therapeutic sunscreens) to make sure they are safe, efficacious and high quality. This means that therapeutic sunscreens need to meet all the legal requirements for therapeutic goods before they can be supplied in Australia. Sunscreens in our Australian Register of Therapeutic Goods (ARTG) are approved for supply in Australia. Most sunscreens in the ARTG are listed (lower risk) medicines.
Therapeutic sunscreens include:
- Primary sunscreens: Products that are used primarily for protection from UV radiation.
- Some secondary sunscreens: Products with a primary purpose other than sun protection, that also contain sun screening agents and are not excluded from therapeutic goods legislation. E.g. sunbathing and moisturising skin care products with an SPF of over 15.
Many secondary sunscreen products, such as cosmetic sunscreens, are not considered to be therapeutic goods and are 'excluded' from therapeutic goods legislation. These product types are outlined under the Therapeutic Goods (Excluded Goods) Determination 2018.
Sunscreen use
Sunscreens provide one of the best ways to protect yourself from the sun’s ultraviolet (UV) rays, which can cause skin cancer. Australia has one of the highest rates of skin cancer in the world.
Sunscreens contain substances that either absorb or reflect UV rays. They prevent most UV rays from penetrating the skin and damaging skin cells. Many Australians use sunscreens daily. This is why sunscreens need to be regulated in Australia to ensure they are safe, efficacious and of good quality.
Only approved ingredients can be included in sunscreens, and each of these ingredients has been assessed for safety and quality.
Sunscreen products come in many forms including creams and aerosol sprays. The amount of a sunscreen you need to use is explained on the label and when used as intended should provide the appropriate protection.
The TGA requires the efficacy of each sunscreen product to be tested to determine the sun protection factor (SPF). The SPF value for the product is printed on the label.
Sunscreen labels
We regulate the information on sunscreen labels to ensure that people know such things as:
- how much sunscreen to use for full protection
- how often to reapply a sunscreen
- the SPF of a sunscreen.
Information about additional sun protection methods must also be included on sunscreen labels. This includes advice to:
- avoid excessive exposure to the sun
- use protective clothing, hats and sunglasses.
Use sunscreens as directed on the label to maintain sun protection.
Ingredients on labels
All active ingredients must be declared on the labels of therapeutic sunscreen in Australia.
Nanoparticles
A nanoparticle ranges from one to 100 nanometres in size (a nanometre is one-millionth of a millimetre) and is invisible to the human eye. Humans are exposed to nanoparticles through the air and water in the form of smoke, dust, ash and fine clays. Nanoparticles are also found in some foods and cosmetics
Nanoparticles are used in some sunscreens. Ingredients may be used in nanoparticle form in therapeutic sunscreens if they have been evaluated and approved by us. Sunscreen labels do not have to declare the particle size of the active ingredients.
There is no evidence suggesting that nanoparticles in sunscreen are unsafe. Evidence shows nanoparticles in sunscreens are highly unlikely to cause harm because they remain on the surface of the skin.
Broad spectrum and Sun protection factor (SPF)
The SPF indicates how effective the sunscreen is against sunburn. The term broad spectrum means that sunscreen protects against the sun’s ultraviolet A (UVA) and ultraviolet B (UVB) rays. UVA is the radiation that is believed to be the main cause of long-term damage. Sunscreens that are not broad spectrum only protect against UVB radiation.
SPF is measured on human skin in a laboratory. Scientists measure how long it takes for intense ultraviolet radiation (specifically UVB) to burn skin with the sunscreen liberally applied compared to bare skin. For example, if skin protected with a sunscreen takes 300 seconds to burn, but bare skin burns in 10 seconds, the sunscreen’s SPF is 30 (300 divided by 10).
SPF30, 40 and 50 sunscreens give a ‘high’ level of protection.
The + (plus) sign associated with the SPF number means that the SPF rating is higher than the number. The + sign can only be used for sunscreen products with SPF 50. Products labelled SPF 50+ have an SPF of 60 or more and provide a ‘very high’ level of protection.
Requirements for therapeutic sunscreens supplied in Australia
Sunscreens must be manufactured by a TGA approved manufacturing facility to be supplied in Australia.
The sponsor of a therapeutic sunscreen must ensure:
- for therapeutic sunscreens that are listed medicines, the product includes only pre-approved ingredients and pre-approved indications
- the product meets the testing and labelling requirements provided in The Australian/New Zealand Sunscreen Standard (AS/NZS) 2604 Sunscreen products — Evaluation and classification (the Australian Sunscreen Standard)
- the product meets manufacturing quality standards
- the product meets all other therapeutic good legislative requirements, such as labelling and advertising
If a sunscreen includes ingredients or indications that are not on our pre-approved list for listed medicines, more steps are required. These sunscreens need to be evaluated by us before going to market, and are entered in the ARTG as registered therapeutic goods.
Sunscreens approved for sale or supply in Australia are entered in the ARTG. To find out if a sunscreen is approved for sale you can search the ARTG.
Monitoring of sunscreens once they are on the market
The TGA can conduct random or targeted post-market reviews to make sure that therapeutic sunscreens supplied in the market comply with our regulatory requirements. Post-market reviews happen after a sunscreen is available for people to buy. Our review program aims to ensure the safety, quality and efficacy of sunscreen products.
Reporting sunscreen issues
The sponsor of a therapeutic sunscreen is required to report any adverse reactions experienced by users of their product to us.
People are also encouraged to report any side effects or problems they experience with sunscreens. We use these reports to monitor possible issues with products available in Australia.
If we get complaints about a particular sunscreen, we may run tests in our laboratories. TGA laboratories are approved to check the level of active ingredients and microbiological quality using samples from retail outlets.
