United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2011_register executive 2011-06-17 article Proposed Rules D09002ee1c7ffc444 D09002ee1c7ffc540 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 76 FR 35672 https://www.govinfo.gov/app/details/FR-2011-06-17/2011-14769 2011-14769 fr17jn11-32 RIN 0910-AF43 4160-01-P Docket No. FDA-1978-N-0018 formerly Docket No. 1978N-0038 https://www.govinfo.gov/app/details/FR-2011-06-17/2011-14769 https://www.govinfo.gov/content/pkg/FR-2011-06-17/html/2011-14769.htm https://www.govinfo.gov/content/pkg/FR-2011-06-17/pdf/2011-14769.pdf Drugs Labeling Reporting and Recordkeeping Requirements 7 p. 35672 35678 76 FR 35672 Title 21 Part 201 21 CFR Part 201 RIN 0910-AF43 Revised Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use; Federal Register Vol. 76, Issue PRORULE 2011-14769 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2011-09-15 Docket No. FDA-1978-N-0018 formerly Docket No. 1978N-0038 4160-01-P 2011-14769 Proposed rule.

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.

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. Reynold Tan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 20993-0002, 301- 796-2090. Drugs Labeling Reporting and Recordkeeping Requirements Sunscreen Drug Products for Over-the-Counter Human Use; Revised Effectiveness Determinations , oira_submission@omb.eop.gov http://www.regulations.gov Vol. 76, no. 117 Office of the Federal Register, National Archives and Records Administration 2011-06-17 continuing daily deposited born digital 419 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2011-06-17 P0b002ee180d72c9b 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr17jn11 https://www.govinfo.gov/app/details/FR-2011-06-17 https://www.govinfo.gov/content/pkg/FR-2011-06-17/pdf/FR-2011-06-17.pdf https://www.govinfo.gov/content/pkg/FR-2011-06-17/xml/FR-2011-06-17.xml fdlp 35301 35711 DGPO 2011-06-17 2024-06-04 FR-2011-06-17 machine generated eng FR FR-2011-06-17 76 117