FDA tentatively agrees to include Parsol 1789 in sunscreen monograph at feedback meeting.
This article was originally published in The Tan Sheet
Executive Summary
FDA "TENTATIVELY" AGREES TO INCLUDE PARSOL 1789 3% IN SUNSCREEN MONOGRAPH, FDA Office of OTC Drug Evaluation Director Michael Weintraub, MD, said at an Aug. 11 "OTC feedback" meeting on Givaudan-Roure's sunscreen ingredient Parsol 1789 (avobenzone). "We tentatively believe that 3% or less Parsol 1789 is safe and effective and can be included in the monograph," Weintraub stated. FDA's May 1993 tentative final monograph on sunscreens did not include Parsol 1789.