Lauder for supplementing monograph
This article was originally published in The Rose Sheet
Executive Summary
Sunscreen ingredients bemotrizinol and bisoctrizole should be added to FDA's OTC sunscreen monograph, Estee Lauder asserts in Nov. 1 comments to the agency, in support of time and extent applications filed by Ciba in April 2005. After reviewing the applications, FDA recommended initially that both ingredients (up to 10% each) be recommended for monograph inclusion. Then in a Dec. 5 Federal Register notice, the agency issued a call for data on bemotrizinol and bisoctrizole as single active ingredients and in combination with other active ingredients in sunscreen products (1"The Rose Sheet" Dec. 12, 2005, p. 3). "The Lauder Companies would like to offer our consumers more broad-spectrum, photostable UVA protective sunscreen products that will protect them from both UVA and UVB," Lauder states, adding: "We petition you to approve these sunscreen actives as soon as possible"...