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FDA is announcing the availability of a compliance guidance for small business entities entitled “Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-the-Counter Human Use; Small Entity Compliance Guide.” This guidance summarizes the June 17, 2011, final rule (76 FR 35620) regarding labeling and testing requirements for OTC sunscreen drug products. Under the 2011 sunscreen final rule, required and permitted labeling is based upon the results of effectiveness testing. The effectiveness testing consists of a sun protection factor (SPF) Test and a Broad Spectrum (ultraviolet A (UVA) and ultraviolet B (UVB) protection) Test. In addition, a test demonstrating water resistance that accompanies the SPF Test to ensure retention of SPF
• Requires that OTC sunscreen drug products follow Drug Facts labeling content and format requirements in § 201.66 (21 CFR 201.66).
• Establishes new labeling requirements for marketed OTC sunscreen drug products set forth in § 201.327 (21 CFR 201.327).
• Revises SPF, broad spectrum, and water-resistant testing requirements and the indications and claims allowed based upon the results of these tests in § 201.327(i) and (j).
FDA is issuing this compliance guidance for small business entities as a level 2 guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on the testing requirements for OTC sunscreen drug products and revision of labeling requirements for OTC sunscreen drug products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in § 201.327 have been approved under OMB control number 0910-0717.
Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see
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