The U.S. Food and Drug Administration today issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States.
The agency is issuing this proposed rule to put into effect final monograph regulations for OTC sunscreen drug products as required by the Sunscreen Innovation Act. OTC monographs establish conditions under which the FDA permits certain OTC drugs to be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) and not misbranded.
Over the last twenty years, new scientific evidence has helped to shape the FDA’s perspective on the conditions, including active ingredients and dosage forms, under which sunscreens could be considered GRASE.
In the proposed rule, the FDA makes the following proposals for sunscreens marketed without FDA-approved applications:
Proposes that of the 16 currently marketed active ingredients:
Two ingredients – zinc oxide and titanium dioxide are both mineral sunscreens that do not penetrate and are not absorbed through the skin and are generally recognized as safe and effective for use in sunscreens. Thus, the safety evaluation does not need to consider more than direct effects on the skin. FDA has sufficient evidence that they are GRASE Category I.
Based on existing data FDA also has concluded that two active ingredients, PABA (amino benzoic) and trolamine salicylate are unsafe and therefore are Category II. Based on information available to FDA, these two active ingredients are not currently used in any sunscreens currently marketed in the United States.
According to the FDA, the Category III sunscreen ingredients lack enough data to support whether they are generally recognized as safe and effective and states that existing evidence suggests that these active ingredients are, or may be, absorbed through the skin, and data about the consequences of this absorption are missing. The 12 Category III sunscreen ingredients are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone.