Australian recalls reignite debate over sunscreen regulation and trust.
Confidence in sunscreen labelling was seriously challenged in 2025 when Australian authorities recalled multiple products after repeat testing revealed that labelled SPF 50+ protection could not be reliably reproduced.
In a perspective published in the British Journal of Dermatology, Australian experts say the recalls have exposed critical weaknesses in sun protection factor testing and regulatory oversight, raising questions that extend well beyond national borders.
“Australia, which has among the highest rates of skin cancer globally, has traditionally been regarded as having rigorous sunscreen regulation,” the authors wrote.
“Recent sunscreen recalls in Australia, however, highlight important shortcomings in SPF testing and regulatory oversight that are relevant to dermatologists worldwide.
“These events prompt a broader question: should sunscreens continue to be viewed primarily as consumer products, or as preventive therapeutics with corresponding expectations of accuracy and accountability?”
More than 20 sunscreens were last year added to the list of recalled products as part of a sweeping Therapeutic Goods Administration investigation.
The ongoing investigation followed a report published in January 2025 by consumer watchdog CHOICE which revealed the results of its testing of 20 sunscreens showing only four products lived up to their claims of SPF ratings.
Using 10 adult volunteers and a calibrated “solar simulator”, CHOICE applied incremental doses of light to both protected and unprotected skin and compared the pair, including against a control sunscreen with a known SPF.
“Of the 20 sunscreens we tested, only four managed to match their SPF claims. Sixteen of the 20 sunscreens we tested failed,” said CHOICE.
“Those failures ranged from a claimed SPF 50+ that actually tested at an SPF of just four, all the way through to results in the 20s, 30s and 40s.”
Co-author and Queensland dermatologist Dr David Lim, told Dermatology Republic that he believed there was a need to look at much more than simply SPF numbers when choosing and using sunscreen.
“There’s so much for consumers to understand and all they look at is a figure,” he said.
“You can have one sunscreen that can be applied in the recommended dose to give you the SPF 50. For example, you apply 3ml. It blends nicely that will give you an SPF 50.
“You try to use 3ml of something else, but because of the tinted consistency, especially in darker skin, doesn’t blend as well.
“Then they use 1.5ml, which gives them a theoretical SPF of 25.”
He said the effectiveness of sunscreens depended on more than just the SPF number – skin type, how much needs to be applied, and how often were also vital.
The fact that sunscreens were regulated also made it difficult for specialists to openly recommend different brands accordingly.
“The TGA blocks the voices that try to do good but doesn’t regulate the fundamentals of sunscreen,” he said.
In their perspective, Dr Lim and his co-author Dr Xiaozhun Hang wrote that sunscreen remained one of the most effective preventive interventions in dermatology, with robust evidence demonstrating reductions in keratinocyte carcinoma and melanoma risk.
They questioned whether the sunscreen recall of 2025 should prompt a broader reconsideration of whether sunscreens should continue to be framed primarily as consumer products, or more appropriately recognised as preventive therapeutics requiring heightened standards of accuracy and accountability.
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They noted that in the CHOICE investigation, one widely used mineral sunscreen demonstrated marked inconsistency on repeat testing, with reported SPF values ranging from approximately SPF 4 to greater than SPF 60.
Following review by the TGA, this product was recalled, along with several other sunscreens sharing a common base formulation. Further investigation indicated that many of these products relied on SPF testing conducted by the same overseas laboratory, raising concerns regarding test reproducibility and laboratory quality control.
“From a clinical perspective, these discrepancies are significant,” they wrote.
“Patients are routinely counselled that SPF 50+ sunscreens provide approximately 98% UVB attenuation under standardised conditions, whereas an SPF 4 product provides substantially less protection, closer to 75%.
“For patients at high risk of skin cancers or with photosensitive dermatoses, this difference may meaningfully alter ultraviolet exposure.
“Sunscreens, although topical, function as preventive therapeutics at a population level, and misclassification of this magnitude undermines both patient safety and trust in dermatologic recommendations.”
In Australia, sunscreens are regulated as therapeutic goods, requiring manufacturers to substantiate SPF claims using internationally recognised methods, most commonly ISO 24444 in-vivo testing.
While familiar to dermatologists, this method is not without well-recognised limitations, the authors said.
“It relies on visual assessment of erythema endpoints and minimal erythema dose determination in human volunteers, using discrete geometric dose series. As a result, SPF is not a continuous variable, and subjective judgement is inherently embedded within the testing process,” they wrote.
“Laboratories must preselect exposure ranges around an anticipated SPF value, creating unavoidable expectation bias and pressure to identify a minimal erythemal response within the mid-range of doses.”
The fallout from the Australian recalls extended beyond the affected products themselves, Dr Lim and Dr Hang wrote.
Dermatologists increasingly report being asked whether sunscreen labels can be trusted at all, placing clinicians in the difficult position of acknowledging the limitations of SPF testing while reinforcing that sunscreen remains a cornerstone of effective photoprotection.
“Public discussion risks drifting toward the mistaken conclusion that sunscreen protection is fundamentally unreliable, rather than imperfect but beneficial,” they wrote.
“Reduced sunscreen use, particularly in high-UV environments, would be an unfortunate and unintended outcome.
“Acknowledging these limitations does not negate the clinical significance of gross SPF misclassification.
“These limitations are intrinsic to erythema-based in-vivo SPF testing and cannot be fully resolved through laboratory auditing alone. While all SPF testing contains variability, a product labelled SPF 50+ but repeatedly testing near SPF 4 represents what can reasonably be attributed to expected methodological variability.
“However, such discrepancies have undermined clinician confidence, patient trust, and public health messaging.
“Regulatory auditing, inter-laboratory comparison, and post-market surveillance therefore remain essential, not to eliminate subjectivity entirely, but to ensure results remain within clinically acceptable bounds.”
Dr Lim told Dermatology Republic that numerical SPF values should be interpreted as relative indicators rather than exact measures of protection.
The central message remained clear, however – consistent and generous sunscreen application was critical, and maintaining confidence in sunscreen labelling was essential to support effective photoprotection at both individual and population levels.
“I think TGA has got to look at the better way of regulation,” said Dr Lim.
“It’s not an easy way, but a better way. The big picture is that have a look at how SPF is tested. The big picture is that we need to have a really good understanding of real-world SPF versus tested SPF.”
