Most sunscreens are regulated by the TGA.
Using sunscreens helps protect you from the sun’s ultraviolet (UV) rays, which cause skin cancer. Sunscreens contain substances that either absorb or reflect UV rays. They prevent most UV rays from penetrating the skin and damaging skin cells however, they do not block 100% of harmful UV radiation.
Sunscreens considered to be therapeutic goods are regulated in Australia to ensure their safety, quality and efficacy. The majority are listed medicines with an 'AUST L' identification number.
For information on supplying or selling a sunscreen in Australia, see Supply a non-prescription medicine.
Sunscreens we regulate
Sunscreens regulated by the TGA and approved for supply in Australia can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Products that are used primarily to protect the skin from ultraviolet (UV) radiation.
Some secondary sunscreens
Products that contain sun screening agents but:
- have a primary purpose other than sun protection. For example, moisturising skin care products with a SPF of over 15.
- are considered to be therapeutic goods. For example, they are not deliberately 'excluded' from being regulated as a therapeutic good by legislation. These excluded products are outlined in the Therapeutic Goods (Excluded Goods) Determination 2018.
Reporting sunscreen issues
You are encouraged to report a problem or side effect with a sunscreen to the TGA.
Reports contribute to our ongoing monitoring of sunscreens.
How we monitor sunscreens on the market
We actively monitor therapeutic sunscreens in the market through both laboratory testing and compliance reviews to ensure they comply with our safety, quality and efficacy requirements.
If we identify a potential safety concern, we investigate it and take action if needed.
This may include:
- publishing safety alerts
- recalling products that do not meet Australian standards.
The results of these investigations are published on our website as alerts.
- If you've purchased this sunscreen, do not spray it directly on your face. Spray the sunscreen onto your hands and then apply on your face.
- Mentholatum Australasia Pty Ltd is recalling two batches of Natural Instinct Kids SPF50+ Clean Sunscreen 200mL topical cream and 50mL rollerball products after receiving reports that the sunscreen fluid is splitting into layers.
- The 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 medicinal products
- Sunscreen SPF testing by AMA Laboratories - Regulatory update. Possible fraudulent testing of sunscreens and TGA efforts to mitigate effect on Australian consumers.