Top sunscreens facing formula change after review

Several Australian sunscreens may need to be reformulated after a review into several active ingredients by the regulator.

Several Australian sunscreens may need to be reformulated after a review into several active ingredients by the regulator recommended changes to improve “safety standards”.

The Therapeutic Goods Administration (TGA) has revealed a proposal to lower the maximum concentration of three compounds in sunscreens after several other countries introduced limits or even bans.

It comes after a review by the regulator, released in February, identified the active ingredients homosalate and oxybenzone, and a degradant known as benzophenone, as potential health risks in higher doses.

A TGA statement said products with these compounds should “be reformulated to ensure sunscreens meet the highest standards of safety for prolonged and frequent use”.

But the administration emphasised products on the market that currently have these ingredients above the suggested new limits were still safe to use.

“The expert clinical advice remains that the benefits of all sunscreens available in Australia continue to far outweigh any risks,” the statement said.

“The benefits of sunscreen in preventing skin damage and skin cancers are well established.

“Australians are urged to continue using sunscreen.”

The European Union set restrictions on the maximum amount of homosalate and oxybenzone in cosmetic sunscreens in January this year, while it banned the use of benzophenone in cosmetic products in November 2023.

The new Australian proposal comes just weeks after sunscreen regulation hit headlines across the country and the TGA launched an investigation into reports multiple products had an SPF lower than advertised.

Consumer group CHOICE released a report last month revealing it had commissioned independent laboratory tests on multiple Australian sunscreens.

The tests found 16 of 20 sunscreens advertised as SPF50+ offered lower protection than claimed, with their results ranging from a low of four to 41.

SPF50 blocks 98 per cent of ultraviolet radiation (UVR) while an SPF of 4 blocks 75 per cent of UVR.

The results from the CHOICE-commissioned testing sparked headlines across the country.

The TGA is now investigating.

CHOICE’s report was disputed by several sunscreen brands and the TGA’s investigation is still underway.

The TGA said this week’s proposal — which is separate to the investigation into advertised SPF levels — was prompted by factors including “regulatory developments overseas” and its February review into sunscreen ingredients.

That review focused on seven ingredients and ultimately recommended changes to three.

“The two main issues considered in this review were the evidence for the ability of these ingredients to penetrate the skin to reach viable cells systemically, and the potential toxicity exerted by them,” a TGA statement said.

The regulator’s proposal noted oxybenzone — which is not considered a “reef safe” ingredient — had already been phased out by Australian sunscreen manufacturers.

But the proposal said the second ingredient on their list, homosalate, was widely used in sunscreen — at concentrations up to 15 per cent.

The TGA has suggested three different options for upper limits, ranging from 0.28 per cent to 4.35 per cent, depending on its use.

The TGA has urged the public to continue to wear sunscreen.

A recent evaluation by the federal Health Department’s Australian Industrial Chemicals Introduction Scheme of benzophenone — the third compound identified by the TGA proposal — found it “may pose a health risk to the public if used repeatedly over time”.

The TGA’s proposal suggested changing the maximum concentration for benzophenone to 0.0383 per cent for sunscreen.

The consultation period will run until August 12, with the proposal to be considered by a joint Federal committee in September.

The TGA urged consumers to continue to wear sunscreens and, in a statement released alongside the February review, said sun damage from avoiding sunscreen was far riskier.

“While some theoretical risks associated with frequent sunscreen use over a lifetime have been identified, they are minimal compared with the proven dangers of prolonged sun exposure and sun burn,” the statement said.

“Tragically, around 2000 people die each year from skin cancer in Australia.

“Sun protection, which includes the use of sunscreen, remains the best way to prevent skin cancer.”

Originally published as Top sunscreens facing formula change after review