Enforcement Policy-Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Enforcement Policy--OTC Sunscreen Drug Products Marketed Without an Approved Application." This guidance describes FDA's approach to enforcement for over-the-counter (OTC) sunscreen products marketed without approved applications before a final OTC sunscreen drug monograph becomes effective. This guidance finalizes the draft guidance of the same name issued June 17, 2011.