'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.”

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OTC sunscreen manufacturers interested in continuing to use 12 active ingredients common in many products must provide a wealth of safety data to FDA under the agency's proposed final sunscreen monograph.

The proposed rule released Feb. 21 also discusses dosage forms, green-lighting most common formats – oils, lotions, creams, gels,...