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FDA avobenzone 2% minimum in combo sunscreens "arbitrarily imposed" -- Sun Pharma.

This article was originally published in The Tan Sheet

Executive Summary

FDA AVOBENZONE 2% MINIMUM IN COMBO SUNSCREENS "ARBITRARILY IMPOSED," SUN Pharma of Paramus, N.J. argues in Oct. 16 comments on FDA's proposed amendment to the sunscreen tentative final monograph. Published in the Sept. 16 Federal Register, the amendment designates avobenzone a Category I ingredient and allows its use as a "broad spectrum" sunscreen agent alone in concentrations up to 3% and in combination with other Category I ingredients in levels between 2%-3% ("The Tan Sheet" Sept. 23, p. 15). FDA set the 2% minimum level for avobenzone in combination sunscreens to ensure that each ingredient in a combination product contributes to the overall effectiveness.

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