Australia's TGA Issues Guidance on Sunscreen Labelling Practices to Address Misuse of ARTG Listings

On January 23, 2026, the Therapeutic Goods Administration (TGA) of Australia issued a statement addressing concerns about sunscreen labelling practices after reports that some companies were using a single Australian Register of Therapeutic Goods (ARTG) AUST number on multiple sunscreen products with different names or intended uses than those recorded in the ARTG, potentially putting products outside legal registration requirements. Under the Therapeutic Goods Act 1989, sunscreens represented as primarily protecting against UV radiation must be included in the ARTG, and the name and indications on the product label must match the ARTG entry. If they do not, the product is considered not listed, and manufacturing, advertising, or supplying it can amount to criminal offences with potential civil penalties. The TGA’s statement provides guidance to sponsors on how to ensure compliance, including applying for new ARTG listings with accurate product details and certifying evidence supporting claims. The TGA has contacted known non-compliant suppliers and will continue reviewing manufacturing, labelling, and supply practices, with possible enforcement actions including quarantine, relabelling, infringement notices, civil penalties, or criminal prosecution where warranted