FDA Seeks To Nix Some Forms From Sunscreen Monograph
This article was originally published in The Tan Sheet
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FDA’s advanced notice of proposed rulemaking starts the process of eliminating several other sunscreen delivery formats from the monograph, despite requests by marketers. Wipes, towelettes, powders, body washes and shampoos will not be eligible for inclusion in the OTC sunscreen monograph if ANPR language survives the rulemaking process. The only way FDA would allow these formats in the monograph is through time and extent applications. The forms are not included because they were not marketed OTC before the drug review began, FDA said in the June 17 ANPR. The agency’s decision means La Fresh and Supergoop! sunscreen wipes will not be allowed under the monograph. Nor will Innovative Skincare's iS Clinical sunscreen powders, Solise sunscreen body wash or many other products. For TEAs, FDA considers five continuous years in same country as proof of a product meeting the “material time” standard. For “material extent” proof, TEA sponsors must include information on markets where a product has been available to show that the information can be extrapolated to use of the product in the U.S. |