Testing flaws prompt a wave of voluntary product 'pauses' while the TGA investigates.
More sunscreens have been “paused” from sale as the Therapeutic Goods Administration continues its active investigation into sunscreen formulations.
The investigation has also seen the voluntary recall of one brand – Ultra Violette Lean Screen.
The TGA is scrutinising both the reliability of sun protection factor (SPF) testing and the adequacy of evidence to support labelling claims.
This means future regulation may tighten around how sunscreen efficacy is proven.
If products are found to lack sufficient evidence, the TGA may mandate recalls, require reformulation or relabelling of SPF claims and introduce stricter testing requirements.
The TGA’s investigation followed a report by consumer watchdog CHOICE which found a number of sunscreens did not meet their claimed SPF.
“The TGA’s investigation is ongoing and is currently focused on a comprehensive review and analysis of the high volume of data received from sponsors. Given the complexity and scale of the material involved, this process will take time,” the TGA said in a statement.
“Variability in Sun Protection Factor (SPF) testing results associated with the ISO 24444:2019, Cosmetics — Sun protection test methods — In vivo determination of the sun protection factor (SPF) is a known issue.
“This is due, in part, because it relies on human subjects and a visual estimation of individual skin responses.
“The TGA is currently reviewing existing SPF testing requirements. In doing so, the TGA is exploring alternative test methods that may be more reliable, including in vitro test methods.
“Through its risk-based approach to the regulation of therapeutic goods, the TGA will take regulatory action as appropriate.”
In the meantime, the regulator warned against abandoning the use of sunscreen.
“Given Australia’s high incidence of skin cancer, the TGA reiterates that using sunscreen is an important measure to prevent the harmful effects of ultraviolet radiation,” it said.
“This should be combined with seeking shade, wearing a wide-brimmed hat, wearing protective clothing and using sunglasses.”
However, a handful of companies have moved to “pause” sales of some products.
In a statement on its website, Outside Beauty & Skincare said it had “momentarily removed” its SPF50+ Mineral Primer from its website.
“With the utmost safety and concern for our customers, we have momentarily removed the SPF 50+ Mineral Primer from our website while we investigate the efficacy and stability of this product,” the company statement said.
“In light of recent events, it has come to our attention that this formula has similar active ingredient concentrations as another brand that has had variable SPF testing results. We have received no information or evidence to suggest these formulas are identical or the same and are not privy to discuss our manufacturing processes.
“Your skin protection is our #1 priority, so while we get to the bottom of this to see if there is an issue, we have decided to be extra cautious and stop selling this product voluntarily.”
The company also sought to clarify a recall notice sent out on 25 August by Adore Beauty “in error”.
“We would like to ensure that the product has not be recalled at this time, and we have not received any notification from the TGA to initiate a recall,” the company statement said.
“To protect our customers, we decided to stop the sale of the SPF 50+ Mineral Primer, a decision that was done voluntarily and as a complete precaution. We apologise for any alarm Adore Beauty’s notification may have caused while we wait for more information from efficacy and stability testing.”
Found My Skin also paused sales of its SPF50+ and made a statement on its website.
“In light of the evolving discrepancies and uncertainty around varied results and testing of SPF, Found My Skin have made the decision to pause sales of the SPF50+ as a precautionary measure while we await more results,” the company said.
“We understand the uncertainty caused by these discrepancies and thank you for your patience and understanding while our investigations continue. We will work with the TGA to seek clarity and be guided by TGA advice moving forward.”
Endota said it was placing a temporary hold on the sale of Mineral Protect SPF50 and Natural Clear Zinc SPF50+ while “we undertake additional independent re-testing of the formulations”.
“Given the evolving landscape and our duty of care, we believe this temporary pause is the responsible course of action,” the company’s statement said.
However, the company stopped short of suggesting customers stop using the product or offered refunds.
“While we have chosen to place a temporary pause on sales of our SPF products, it is entirely your choice if you wish to continue using them. Both have been developed with great care and have consistently met the standards set by the Therapeutic Goods Administration (TGA),” Endota’s statement said.
“We’re not currently offering refunds on our Mineral Protect SPF50 Sunscreen & Natural Clear Zinc SPF50+. For now, we’ve placed a temporary pause on sales while we carry out further testing.”
Naked Sundays paused sales on its Collagen Glow Mineral product voluntarily.
“Our Collagen Glow mineral has not been recalled and adheres to all current TGA guidelines and testing protocols,” the company said in a statement.
“Without being asked by the TGA, we have proactively initiated extra independent SPF testing to back up our current testing, and while we await results, we have paused sales on this product. No other Naked Sundays products have been impacted.
“We’ve received a large number of customer inquiries for our Collagen Glow Mineral sunscreen in particular. While we don’t disclose our manufacturing partners due to confidentiality agreements, we can confirm we produce this product at multiple manufacturers both in Australia, and in the USA where we use a unique combination of sources, manufacturing methods & ingredients.
“We can also confirm the product complies with current TGA standards and poses no safety risk to consumers.
“We are pleased to report that preliminary SPF results from a new independent lab for our Collagen Mineral produced by our US manufacturer, has returned preliminary results to support the label claim of SPF50.”
Last month Grace & Fire Pty Ltd, trading as Ultra Violette and the TGA issued a recall of all batches of Ultra Violette Lean Screen SPF 50+ due to “inconsistency in the SPF level of the product”.
In a statement, the TGA said independent testing of Ultra Violette Lean Screen SPF 50+ sunscreen demonstrated inconsistency in the SPF level of tested product.
“This testing found the product may have an SPF level ranging from 4 to 64.32,” the TGA said.
“Ultra Violette continues to undertake further independent testing to identify a potential cause of these inconsistent SPF levels.”
More information about this recall is available here.
Ultra Violette issued its own statement about the recall.
“We had multiple, independent labs conduct new tests of Lean Screen. This week, we received results from those tests that demonstrated significant and, candidly, atypical variability,” the company said.
“Across eight different tests, Lean Screen has now returned SPF data of 4, 10, 21, 26, 33, 60, 61, and 64. That wasn’t good enough for us, and it isn’t good enough for you.
“We are deeply sorry that one of our products has fallen short of the standards we pride ourselves on and that you have come to expect of us.”
The company said the recall only related to its Lean Screen product.
“Additional testing on all Ultra Violette products reinforced our confidence in the rest of our line,” it said.
