Ecamsule Eligibility for Inclusion in Monograph; Over-the-Counter Sunscreen Drug Products for Human Use; Request for Safety and Effectiveness Data

Zusammenfassung

The Food and Drug Administration is announcing a call-for-data for safety and effectiveness information on the following condition as part of FDA's ongoing review of over-the-counter (OTC) drug products: Ecamsule (terephthalylidene dicamphor sulfonic acid), in concentrations of up to 10 percent, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients that are generally recognized as safe and effective (GRASE) and are found in the sunscreen monograph regulations. FDA reviewed a time and extent application (TEA) for ecamsule and determined that it is eligible for consideration in our OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether ecamsule can be generally recognized as safe and effective (GRASE) for its proposed OTC use.