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Sunscreen monograph amendment

This article was originally published in The Rose Sheet

Executive Summary

Labeling of sunscreen products introduced after Sept. 1 will need to reflect U.S. Pharmacopeia name changes for four active ingredients, FDA says in technical amendment published in the Federal Register June 20. Changes were proposed by the USP in 2000 based on names endorsed by the U.S. Adopted Names Council, FDA notes. Proposal was accepted in March 2001 and becomes effective Sept. 1. New names include meradimate for menthyl anthranilate; octinoxate for octyl methoxycinnamate; octisalate for octyl salicylate; and ensulizole for phenylbenzimidazole sulfonic acid. Comments on the amendment will be accepted until Aug. 19...

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