FDA Announces Enforcement Policy for Avobenzone-Containing Sunscreen Products

Summary

The FDA is announcing an enforcement policy allowing the over-the-counter (OTC) marketing of sunscreen products containing avobenzone (Parsol 1789) at concentrations of up to 3% alone and 2-3% in combination with other approved OTC sunscreen ingredients. This policy is pending the establishment of a final monograph covering sunscreen drug products.