Sunscreen Drug Products for Over-the-Counter Human Use; Marketing Status of Products Containing Avobenzone; Enforcement Policy

The Food and Drug Administration (FDA) is announcing an enforcement policy allowing over-the-counter (OTC) marketing of sunscreen drug products containing avobenzone (Parsol<Register> 1789) at concentrations of up to 3 percent alone and 2 to 3 percent avobenzone in combination with the OTC sunscreen ingredients cinoxate, diethanolamine methoxycinnamate, dioxybenzone, homosalate, octocrylene, octyl methoxycinnamate, octyl salicylate, oxybenzone, sulisobenzone, and/or trolamine salicylate. OTC marketing of such drug products is being permitted pending establishment under the OTC drug review of a final monograph covering sunscreen drug products. FDA anticipates that sunscreen drug products containing up to 3 percent avobenzone alone and 2 to 3 percent avobenzone in combination with the proposed Category I cinnamate, benzophenone, salicylate, and/or diphenylacrylate sunscreen ingredients will be determined to be generally recognized as safe and effective and not misbranded.