Sunscreens are subject to specific regulations that cover the approved ingredients they can contain and testing requirements.
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.
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.
- TGA publishes updated guidelines for sunscreensThe TGA has updated the Australian Regulatory Guidelines for Sunscreens (ARGS) to align with the data requirements for all ingredients proposed to be included in the Therapeutic Goods (Permissible Ingredients) Determination
- Update to the Manufacturing Principles for medicines, APIs & sunscreensUpdate to the manufacturing principles for medicinal products
- About sunscreensInformation about how sunscreens are approved for supply in Australia and what you will see on sunscreen labels.
- Sunscreen manufacturingSunscreen manufacturing guidance updated to reflect recent changes to TGA guidance material
- Findings from TGA’s compliance review of sunscreensFindings from our recent desktop review of listed sunscreen products
- Literature review on the safety of titanium dioxide and zinc oxide nanoparticles in sunscreensThe TGA's scientific review on the safety of nanoparticles in sunscreens has been updated.
- Consultation: Clarification and updates to the regulation of sunscreensThe TGA is seeking feedback on proposed clarification and updates to the regulation of sunscreens. Closing date: 31 May 2023