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 This guidance finalizes the draft guidance of the same name issued June 17, 2011.
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Enforcement Policy-Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Guidance for Industry; Availability
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 Wi...
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83 FR 23917
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“Enforcement Policy-Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Guidance for Industry; Availability,” thefederalregister.org (May 23, 2018), https://thefederalregister.org/documents/2018-10994/enforcement-policy-over-the-counter-sunscreen-drug-products-marketed-without-an-approved-application-guidance-for-indust.