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Sunscreen ingredients

This article was originally published in The Rose Sheet

Executive Summary

FDA proposes in the June 8 Federal Register to remove five Category 1 (generally recognized as safe and effective and not misbranded) ingredients from the OTC sunscreen tentative final monograph due to the absence of USP standards and the "apparent lack of interest in establishing USP monographs' by industry for those ingredients. The ingredients are: digalloyl trioleate, ethyl 4-[bis(hydroxypropyl)] aminobenzoate, glyceryl aminobenzoate, lawsone with dihydroxyacetone, and red petrolatum. The comment deadline on the proposal is Aug. 22. USP monographs exist for six of the 20 Category 1 ingredients listed in the May 1993 sunscreen TFM. CTFA and NDMA notified FDA in February that industry is working with USP to develop standards for nine other ingredients lacking USP monographs ("The Rose Sheet" March 28, p. 6)
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