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OTC Drugs Regulation FDA

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

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Executive Summary

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.”

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