The TGA regulates sunscreens in Australia that are classified as therapeutic goods to make sure they are safe, efficacious, and of high quality. Understanding the regulation of therapeutic sunscreens explains which sunscreens are regulated by TGA (therapeutic sunscreens) and which, providing they meet certain requirements, are not regulated by us (e.g., cosmetic sunscreens). This guidance also provides:

• Information on the Australian regulatory requirements for therapeutic sunscreens

• Requirements for new sunscreen ingredients

• Guidance on how to change an entry in the Australian Register of Therapeutic Goods (ARTG) for a listed sunscreen