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FDA Corrects Rule on OTC Sunscreen Drug Labeling

The Food and Drug Administration has issued a correction to its final rule, which effective June 18, 2012, will require over-the counter sunscreen products to comply with certain content and format requirements for OTC drug labeling. FDA is correcting a…

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formula for calculating the erythema action spectrum weighting factor in 21 CFR 201.327(i)(1)(ii)(A)(2) and (3). (See ITT's Online Archives or 06/14/11 news, 11061447, for BP summary of the final rule.)