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Sunscreen claims, OTC labeling

This article was originally published in The Rose Sheet

Executive Summary

FDA's latest public estimate of when it will issue a proposed rule on sunscreen UVA/UVB claims is April 2003, according to the agency's 1unified agenda, appearing in the May 13 Federal Register. The target date is beyond previous indications from the agency that amendment to sunscreen final monograph would be published before the end of 2002. Agenda targets December for release of proposal providing flexibility for labeling of small one- or two-dose "convenience" size OTC drugs. While rulemaking proceeds, such products are excused from complying with OTC drug labeling requirements (2"The Rose Sheet" April 8, 2002, p. 10). Current OTC review agenda is more abbreviated than usual; FDA decided to list only those actions expected to be completed within next 12 months, the agency said...

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Target date for completing notice of proposed rulemaking for sunscreen UVA/UVB products pushed back to August in FDA's 1unified agenda published in the Federal Register Dec. 9. Most recent public estimate for completion was April (2"The Rose Sheet" May 20, 2002, In Brief). Proposal for providing labeling flexibility for "convenience" size OTC drugs targeted for March, while antiperspirant products final monograph is expected to be completed in April, agency adds. Final action on skin protectant products anticipated in April with NPRM for astringent scheduled to follow in August...

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