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CARES Act Makes Threatened Sunscreen Ingredients GRASE Again, But Next Steps Uncertain

 
• By Ryan Nelson

Many questions remain following the late March enactment of the US CARES Act, which overhauls the FDA’s OTC drug regulatory framework and resets the GRASE status of long-used sunscreen drug ingredients whose safety and effectiveness have come under question at the FDA.

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Since the US Food and Drug Administration’s proposed rule for a final OTC sunscreen drug monograph issued in early 2019, industry has been faced with the monumental task of establishing the absorption potential and resulting safety of eight popular UV filters with extensive histories of use in the US and abroad.

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