Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients

Zusammenfassung

The Food and Drug Administration (FDA) is announcing a call- for-data for safety and effectiveness information on the following conditions as part of FDA's ongoing review of over-the-counter (OTC) drug products: Amiloxate (isoamyl p-methoxycinnamate), up to 10 percent, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients; enzacamene (methyl benzylidene camphor), up to 4 percent, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients; and octyl triazone, up to 5 percent, 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 it's 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.