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We’ve updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 32 listed medicines, including:
- 19 sunscreens:
- These sunscreens were targeted for review because they used the same base formulation as Ultra Violette Lean Screen SPF 50+ sunscreen (formerly AUST L 332788) that showed lower than claimed Sun Protection Factor (SPF) testing results, following the 2025 CHOICE report on SPF testing of a range of sunscreens on the Australian market.
- Following the review, all 19 sunscreens have been cancelled from the Australian Register of Therapeutic Goods (ARTG) and recalled.
- 13 other products, including:
- Medicines containing phenylalanine
- Medicines reviewed to check whether they meet stability requirements
- Medicines with non-permitted health claims about:
- cardiovascular, neurodegenerative, and metabolic diseases,
- iron deficiency,
- mycosis, vaginosis, intimate discomfort or regeneration of vaginal microbiota,
- nicotinamide adenine dinucleotide (NAD, NAD+, NADH) or nicotinamide mononucleotide (NMN), and
- weight loss.
- Following the review, 9 of these products have been cancelled from the ARTG and 2 have been recalled.
For more information, refer to the database and listed medicine compliance reviews.
To view the compliance reports for the reviewed sunscreens, search for 'lower than claimed SPF' in the search bar in the database. Refer to our website for additional information on Sunscreen SPF testing - information for consumers and Sunscreens using the same base formulation as Ultra Violette Lean Screen SPF 50+ sunscreen.
We are continuing to investigate the concerns arising from the CHOICE report, and will publish the results of compliance reviews of more sunscreens in due course.
What are listed medicines and how are they regulated?
Listed medicines have an 'AUST L' number on the label and packaging, and include products such as vitamins and minerals, traditional Chinese medicines, herbal medicines and some therapeutic sunscreens. Therapeutic sunscreens are products that protect skin from ultraviolet (UV) damage and prevent sunburn. Examples include lotions with a SPF rating of 30 or 50 plus.
These medicines are included in the Australian Register of Therapeutic Goods (ARTG) and can be sold without being checked by the TGA for safety, quality and effectiveness. Instead, sponsors of listed medicines certify that their medicine meets all the relevant legal requirements prior to selling them.
Listed medicines can only contain ingredients that we have assessed to be of low risk. Their indications (therapeutic uses) can only be selected from a pre-approved list. The indications of a listed medicine on its label, packaging or other advertising material must be included in the ARTG entry of the medicine and must be supported by evidence.
We regularly conduct post-market compliance reviews of selected listed medicines to check for compliance. If a medicine is found to not comply with the legal requirements, we take risk-based and proportionate regulatory actions to address the non-compliance.
We publish the outcomes of these compliance reviews on the Listed Medicine Compliance Reports database on a quarterly basis to allow timely public access to safety or efficacy information of reviewed listed medicines. This assists consumers to make informed decisions when self-selecting listed medicines and avoid purchasing a product that may not be appropriate for them.