Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T00-26 Print Media: 301-827-6242 June 8, 2000 Consumer Inquiries: 888-INFO-FDA
The Food and Drug Administration today announced that it will extend, until December 31, 2002, implementation of a comprehensive, final sunscreen monograph. This announcement reflects the agency’s October 1, 1999, decision in a citizen petition response to allow additional time for the completion of a comprehensive sunscreen monograph that is expected to include standards for both ultraviolet A (UVA) and ultraviolet B (UVB) radiation.
In accordance with the requirements of the Food and Drug Administration Modernization Act of 1997 (FDAMA), FDA published in the Federal Register of May 21, 1999, a final OTC monograph for sunscreen products. The monograph did not, however, address certain issues involving active ingredients, labeling, and test methods for products intended to provide UVA coverage.
FDA is amending the date the sunscreen monograph takes effect to accommodate the final completion of standards for UVA formulation ingredients, labeling, and testing. The completed monograph may also address issues associated with the testing and labeling of sun protection factor (SPF) values above SPF 30.
FDA will also consider ways to integrate UVA and UVB indications. As a result of the amendment to the effective date, sunscreen products are not required to comply with the general OTC labeling rule until December 31, 2002.
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