FDA Calls for Sunscreen Safety & Effectiveness Data
07/11/2003
Federal Register Notice: FDA is announcing a call-for-data for safety and effectiveness information on the following conditions as part of FDA's ongoing review of OTC drug products: Amiloxate (isoamyl p-methoxycinnamate), up to 10%, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients; enzacamene (methyl benzylidene camphor), up to 4%, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients; and octyl triazone, up to 5%, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients. FDA has reviewed time and extent applications (TEAs) for these conditions and determined that they are eligible for consideration in the OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether these conditions can be generally recognized as safe and effective (GRAS/E) for their proposed OTC use. To view this notice, click here.
