Ciba Tinosorb sunscreens
This article was originally published in The Tan Sheet
Executive Summary
Ciba Specialty Chemicals should initiate NDA process for UVA/UVB filters Tinosorb M and Tinosorb S to obtain approval as OTC sunscreens, FDA says in July 15 letter denying Ciba's May 21 "time and extent" application to introduce ingredients in the U.S. based on foreign marketing experience. Ciba has "not demonstrated that the ingredients have been marketed for a material time and a material extent," FDA says, noting ingredients must be marketed for a "minimum of five continuous years in the same country and in sufficient quantity." Ciba has only provided two-and-a-half years of continuous use data. TEA was adapted from petition filed by the company Sept. 5, 2000 seeking monograph status for ingredients (1"The Tan Sheet" Sept. 11, 2000, p. 9). FDA decision appears to be first denial of a TEA...