The Therapeutic Goods Administration (TGA) of Australia has launched an extensive review of sunscreen products after a consumer report revealed discrepancies in SPF (sun protection factor) claims among various brands. This move comes in response to findings from an independent study conducted by CHOICE, a consumer advocacy group, which highlighted inaccuracies in the SPF ratings of 16 out of 20 tested sunscreens.
Inconsistent SPF Claims Spark Action
In June 2025, CHOICE’s report revealed that several sunscreens failed to meet their advertised SPF 50+ levels. Among the products tested, seven registered SPF values above 20, eight exceeded SPF 30, and one product, Ultra Violette’s Lean Screen SPF 50+, displayed a shocking range of SPF results from as low as 4 to as high as 64.32.
Following these findings, the TGA announced in August 2025 that Ultra Violette, owned by Grace & Fire Pty Ltd, would recall all batches of its Lean Screen SPF 50+ sunscreen due to the inconsistencies. The company has also voluntarily canceled the registration of the product in the Australian Register of Therapeutic Goods (ARTG).
In a statement, the TGA emphasized that while no serious adverse effects have been reported to date, individuals using the affected sunscreen might face a heightened risk of sunburn and diminished long-term protection against skin cancer.
Expanded Investigations and Manufacturing Scrutiny
The investigation into Ultra Violette’s Lean Screen has broadened to include other sunscreens with similar formulations. According to the TGA, sunscreens in Australia are regulated as either therapeutic goods or cosmetics, depending on their composition and claims. For products listed as therapeutic goods, it is a legislative requirement that SPF claims are accurate and supported by evidence.
The base formulation of Lean Screen, produced by Wild Child Laboratories Pty Ltd, was found to have preliminary SPF testing results indicating that its SPF was unlikely to exceed 21. Alarmingly, some products using this formulation exhibited SPF levels as low as 4. The TGA conducted a Good Manufacturing Practice (GMP) inspection of Wild Child Laboratories and found no production issues that could explain the inconsistencies.
The TGA’s review also raised concerns about the reliability of SPF testing conducted by Princeton Consumer Research Corp (PCR Corp), a UK-based laboratory. "As a part of our investigations, it has come to our attention that some testing laboratories may be more reliable than others. In particular, the TGA has significant concerns about the reliability of SPF testing undertaken by Princeton Consumer Research Corp (PCR Corp), a testing laboratory based in the UK", the TGA stated.
The agency noted that many companies using the base formulation relied on testing by PCR Corp before being made aware of the TGA’s concerns. Despite being notified, PCR Corp has yet to respond to the TGA’s inquiries.
Adding complexity, the TGA acknowledged that variations in excipients such as fragrances and color tints, which individual companies add to the base formula, could potentially impact a product’s SPF level.
Next Steps in the Review Process
The TGA is actively assessing sunscreens listed in the ARTG that may share formulas with Ultra Violette’s Lean Screen. Affected companies have been notified and given an opportunity to provide supporting evidence for their SPF claims before regulatory actions are taken. The TGA has also published a list of products using the same base formulation on its website, which will be updated as investigations progress.
Current standards mandate SPF testing to be conducted on at least 10 individuals, with additional tests required if any results are deemed invalid. To classify as SPF 50+, the average SPF from valid tests must be at least 60.
"The TGA is aware that at least some companies are likely to have obtained preliminary or incomplete test results from an independent laboratory other than PCR Corp that may or may not support the SPF claim of their sunscreen. All affected companies are free to publish their SPF testing", the TGA stated.
In the meantime, the TGA is also providing support to companies that have opted to either cancel or recall affected products. Consumers who purchased any of the identified sunscreens are encouraged to consider alternative options until the review is finalized.
This comprehensive review underscores the importance of ensuring that sunscreen products meet their advertised claims, as deviations can have serious implications for public health and safety.
