Base formulation may be linked to 20 sunscreens falling short of SPF claims, drug regulator finds | Health

The same base formulation has been identified in 20 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.

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 didn’t 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.

Sign up: AU Breaking News email

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 Sunscreen 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

Some of the sunscreen brands have already voluntarily paused supply of their products. The Naked Sundays said in August sales of the Collagen Glow Mineral Sunscreen were “paused” while it awaited further testing to determine if its SPF claims were accurate.

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.

skip past newsletter promotion

Choice chief executive officer 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 has contacted PCR Corp and the 17 brands identified by the TGA for comment.

Continue Reading