FDA Comment Deadline: Sunscreen Drug Products for Over-the-Counter Human Use

Tuesday, May 28, 2019 - 11:45pm

The Food and Drug Administration (FDA) is issuing this proposed rule and seeking public comment to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. This proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. It is being published as part of the ongoing review of OTC drug products conducted by FDA. 

Members of the public can comment by mail, fax, or at Regulations.gov. More information is available at this Federal Register notice