Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
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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.
This is a mirror of the page at HTTP://www.fda.gov/bbs/topics/ANSWERS/ANS01019.html
Please note that this extension does not affect the regulation requiring a warning statement on suntanning preparations that do not contain sunscreen (Title 21 of the Code of Federal Regulations, 740.19). The warning statement requirement became effective May 22, 2000.
Information About Suntan Products, Sunscreens, and Tanning