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FDA Clears Outdated Sunscreen Petitions From Queue With Trio Of Denials

Executive Summary

The agency refers L’Oreal, Shiseido’s Bare Escentuals and Rapid Precision Testing Laboratories to its newly proposed sunscreen rule, which covers most of the points raised in their petitions. Seeking GRASE status for powder dosage forms and higher concentrations of avobenzone, among other asks, the rejected citizen petitions trace back as far as a decade.

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'Data Gaps' Keep 12 Ingredients Off FDA's Proposed OTC Sunscreen Monograph

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.”

Systemic Exposure Data A MUsT For OTC Monograph Sunscreens, Other Topical Drugs In FDA Draft Guidance

Challenges posed by FDA-advised maximal usage trials have been the bane of OTC sunscreen and antimicrobial drug ingredient sponsors recently, but a draft guidance from the agency signals that those trials will be expected generally from companies looking to add topical ingredients to OTC drug monographs. CDER details its expectations for studies of ingredients’ absorption potential to inform systemic exposure and overall safety and efficacy conclusions.

EWG Remains Concerned About SPF Boosting With Anti-Inflammatories

Without an FDA cap on SPF claims, companies continue to answer consumer demand for lofty SPFs using the limited active ingredients cleared for OTC use in the US. The Environmental Working Group says manufacturers also are spiking sunscreen formulas with anti-inflammatory ingredients to boost SPF scores, but some such ingredients may only "mask" signs of UV-induced skin damage.

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