FDA avobenzone 2% minimum level in combo sunscreens "arbitrarily imposed" -- Sun Pharma.
This article was originally published in The Rose Sheet
Executive Summary
FDA AVOBENZONE 2% MINIMUM IN COMBO SUNSCREENS "ARBITRARILY IMPOSED," SUN PHARMA of Paramus, N.J. argues in Oct. 16 comments to FDA on the agency's proposed amendment to the sunscreen tentative final monograph. Published in the Sept. 16 Federal Register, the amendment designates avobenzone a Category I (safe and effective) ingredient and allows the use of the ingredient 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%, with a minimum concentration of 2% ("The Rose Sheet" Sept. 23, p. 10).