Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is proposing to limit the maximum labeled SPF value for over-the-counter (OTC) sunscreen drug products to "50+." We are issuing this proposed rule after reviewing data and information we received on the safety and effectiveness of OTC sunscreen drug products after publication of our 2007 proposed rule. The record does not currently contain sufficient data to indicate that there is additional clinical benefit above SPF 50. This proposal is part of FDA's ongoing review of these products to ensure their safety and effectiveness.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 201 [Docket No. FDA-1978-N-0018; formerly Docket No. 1978N-0038] RIN 0910-AF43 AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to limit the maximum labeled SPF value for over-the-counter (OTC) sunscreen drug products to “50+.” We are issuing this proposed rule after reviewing data and information we received on the safety and effectiveness of OTC sunscreen drug products after publication of our 2007 proposed rule. The record does not currently contain sufficient data to indicate that there is additional clinical benefit above SPF 50. This proposal is part of FDA's ongoing review of these products to ensure their safety and effectiveness. DATES: Submit either electronic or written comments on the proposed rule by September 15, 2011. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by July 18, 2011, (see the “Paperwork Reduction Act of 1995” section of this document). See section VII of this document for the proposed effective date of a final rule based on this proposal. ADDRESSES: You may submit comments, identified by Docket No. FDA-1978-N-0018 and RIN number 0910-AF43, by any of the following methods, except that comments on information collection issues under the PRA must be submitted to the Office of Regulatory Affairs, Office of Management …
Other Federal Register documents from the same docket.
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-The-Counter Human Use; Over-The-Counter Monograph Proposed Order (OTC 000008) Extension of Comment Period
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use; Over the Counter Monograph Proposed Order; Availability
Sunscreen Drug Products for Over-the-Counter Human Use; Correction
Sunscreen Drug Products for Over-the-Counter Human Use; Extension of Comment Period
Sunscreen Drug Products for Over-the-Counter Human Use
Citation: 76 FR 35672
