The same base formulation has been identified in 21 sunscreens that Australia’s medicines regulator has warned are unlikely to have a sun protection factor (SPF) rating of more than 21, with some products as low as SPF 4.
The Therapeutic Goods Administration (TGA) on Tuesday identified sunscreens sold by 17 different companies using a base formulation made by manufacturer Wild Child Laboratories as likely to fall far short of their sun protection factor claims.
Of these, eight sunscreens have been voluntarily recalled and another 10 have had their sales voluntarily “paused” while they are reviewed by the TGA.
The TGA published the list of sunscreens as part of an investigation it launched in June after the consumer advocacy group Choice released its own testing that found several leading Australian sunscreens did not provide the protection that they claimed.
The worst of the sunscreens Choice tested was the Ultra Violette Lean Screen SPF 50+ – a mineral sunscreen which returned a result of only SPF 4 in the tests ordered by the consumer organisation.
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Ultra Violette initially publicly disputed Choice’s methodology and findings before pulling the product from shelves after confirming the brand’s own testing showed inconsistent SPF results.
The TGA on Tuesday said it was concerned test results from its own investigation relating to Lean Screen and its base formulation suggest that similar sunscreens may not provide the SPF the brands claim.
The regulator said preliminary testing of these specific sunscreens showed their protection rating was unlikely to be higher than SPF 21. For at least some of the products, their rating may be as low as SPF 4, the regulator said.
“The TGA has not identified any manufacturing issue that would give rise to this result. The manufacturer has ceased manufacture and supply of the base formulation,” the TGA said.
The 20 sunscreen products identified by the TGA as using the same base formulation as the Ultra Violette Lean Screen SPF 50+ are:
Aspect Sun SPF50+ Physical Sun Protection
Aspect Sun SPF50+ Tinted Physical Sun Protection
Aesthetics Rx Ultra Protection Sunscreen Cream
New Day Skin Good Vibes Sunscreen SPF50+
New Day Skin Happy Days Sunscreen SPF50+
Allganics Light Sunscreen SPF50+
Beauti-FLTR Lustre Mineral SPF50+
Found My Skin SPF 50+ Tinted Face/Body Cream
Ethical Zinc Daily Wear Light Sunscreen
Ethical Zinc Daily Wear Tinted Facial Sunscreen (Dark)
Ethical Zinc Daily Wear Tinted Facial Sunscreen (Light)
Endota Mineral Protect SPF50 Sunscreen
We are Feel Good Inc Mineral Sunscreen SPF50+
GlindaWand The Fountain of Youth Environmental Defence Cream SPF50+
Ultra Violette Velvet Screen SPF50 (product export only – not available in Australia)
People4Ocean SPF 50+ Mineral Bioactive Shield Lightly Tinted Cream
McoBeauty SPF50+ Mineral Mattifying Sunscreen
Naked Sundays Collagen Glow Mineral Sunscreen
Outside Beauty & Skincare SPF 50+ Mineral Primer
Salus SPF50+ Daily Facial Sunscreen Broad Spectrum
The TGA said that, as a part of its investigation, it had “come to our attention” that some testing laboratories may be more reliable than others.
The regulator said it had “significant concerns” about the reliability of SPF testing undertaken by Princeton Consumer Research Corp (PCR Corp), a laboratory based in the UK.
The TGA said it was aware many companies responsible for sunscreens manufactured using the base formulation in question relied on testing by PCR Corp to support their SPF claims.
PCR Corp defended its testing regime when contacted for comment.
“Princeton Consumer Research conducts sunscreen testing in good faith, to recognised industry standards, on the specific samples provided to us by sponsors at the time of testing,” the company said as part of a longer statement sent via email on Wednesday.
“We can only speak to the data we generated on the samples we tested; we cannot opine on any subsequently manufactured or sold product that we did not test.”
The Choice chief executive, Ashley De Silva, said consumers would now be expecting companies to provide reassurance their favourite sunscreen was backed by strong testing practices.
“Today’s announcement highlights, yet again, the importance of the TGA’s investigation and the need for changes to how sunscreens are regulated and tested in Australia,” he said.
The TGA on Tuesday said it had notified all companies responsible for affected sunscreens of this testing and its concerns about the reliability of testing performed by PCR Corp.
The TGA said it was considering whether to take regulatory action with respect to those sunscreens but each company was given the opportunity to respond to any proposed regulatory action before it made a decision.
Wild Child Laboratories said in a statement the TGA confirmed no manufacturing issues were identified at its facility that could explain variability in SPF testing results.
“The discrepancies reported in recent testing are part of a broader industry-wide issue,” it said. “The Choice investigation showed that 16 out of 20 sunscreens tested returned results lower than their label claim. These outcomes highlight the well-recognised limitations of in vivo SPF testing methods – a challenge publicly acknowledged by the TGA.
“Wild Child has ceased using PCR and initiated confirmatory testing with other accredited, independent laboratories to validate the SPF performance of our products.”
Guardian Australia on Tuesday contacted the 17 brands identified by the TGA for comment.
Four of those brands responded on Wednesday. Advanced Skin Technology and Aesthetics Rx both said they were investigating and that they had recalled their products named by the TGA.
Jacqueline Hutton, the owner and director of GlindaWand, said it was “extremely distressing” to see her company named given the product was “currently under review”.
Hutton said she wanted to clarify that the product “has not been recalled” but said it had been “removed from sale” on 26 September as a “voluntary precaution” while the company worked with the TGA.
Ultra Violette said it stopped working with the PCR Corp labs earlier this year and had retested the rest of its range at new independent labs with the results “reinforcing our confidence in the rest of our line”.
