EWG Endorses Mineral Sunscreens, Avobenzone And UVA-Protective Chemicals Stranded In Europe
Three-fourths of sunscreens marketed in the US offer “inferior” protection or contain “worrisome” chemicals, according to the Environmental Working Group’s 2020 Sunscreen Guide. The guide shows overwhelming preference for mineral over chemical sunscreens, while also suggesting that Americans would be better off if UVA-protective chemical filters in Europe were allowed stateside.
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The FDA emphasizes that findings from its second, more extensive clinical study on the absorption potential of sunscreen active ingredients are not in themselves signals that the UV filters are unsafe. However, they portend heavy work ahead for industry if the ingredients are to remain GRASE and available for use in OTC sunscreen drug products stateside.
FDA proposed final sunscreen monograph identifies zinc oxide and titanium dioxide as GRASE, two other ingredients as non-GRASE and 12 substances with data gaps, meaning firms must provide safety and effectiveness data or reformulate products that rely on inadequately supported UV filters. EWG says the proposal is “exactly the kind of signal that FDA should be providing for the sunscreen industry.”
The agency maintains maximal usage trials are essential in sunscreen ingredient GRASE assessments, despite industry objections that the tests have not been used for UV filters and no protocol is established. FDA’s final guidance closely mirrors its draft issued a year ago, which stakeholders projected would further delay consumer access to updated sunscreen products.