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Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-the-Counter Human Use

Document ID: FDA-1978-N-0018-0698
Document Type: Rule
Agency: Food And Drug Administration
Topics: Drugs, Incorporation by Reference, Labeling, Reporting and Recordkeeping Requirements
Federal Register Number: 2011-14766
CFR Citation: 21 CFR Parts 201 and 310
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Details Information

Document Subtype: Final Rule
Received Date: June 17 2011, at 12:00 AM Eastern Daylight Time
Start-End Page: 35620 - 35665
Page Count: 46
Comment Start Date: June 17 2011, at 12:00 AM Eastern Standard Time

Attachments:

Refeence 57 The American Academy of Dermatology The Darker Side of Tanning February 1 2009

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Reference 1 FDA List of Docket Submissions Addressed in This Rule Organized by Issue Sunscreen FR Docket References FR 2 15 11

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Reference 10 Fourtanier A et al Sunscreens Containing the Broad-Spectrum UVA absorber Mexoryl SX Prevent the Cutaneous Detrimental Effects of UV Exposure: A Review of Clinical Study Results Photodermatology Photoimmunology and Photomedicine 24 164 174 2008

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Reference 11 De Gruijl F UV Radiation DNA Damage Mutations and Skin Cancer in Environmental UV Radiation: Impact on Ecosystems and Human Health and Predictive Models Springer Netherlands 249 258 2006

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Reference 12 Lucas R et al Solar Ultraviolet Radiation Global Burden of Disease from Solar Ultraviolet Radiation Environmental Burden of Disease Series No 13 World Health Organization 2006.

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Reference 13 Armstrong B K et al Sun Exposure and Skin Cancer Australasian Journal of Dermatology 38 S1 S6 1997

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Reference 14 World Health Organization IARC IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Vol 55 Solar and Ultraviolet Radiation

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Reference 15 Report on Carcinogens Eleventh Edition

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Reference 16 Rabe J et al Photoaging Mechanisms and Repair Journal of the American Academy of Dermatology 55 1 19 2006

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Reference 17 Reynolds, K D et al Predictors of Sun Exposure in Adolescents in a Southeastern U S Population Journal of Adolescent Health 19 409 415 1996

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Reference 18 Robinson J K D S Rigel and R A Amonette Summertime Sun Protection Used by Adults for Their Children Journal of the American Academy of Dermatology 42 746 753 2000

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Reference 19 Ulrich C et al Prevention of Non Melanoma Skin Cancer in Organ Transplant Patients by Regular Use of a Sunscreen A 24 Months Prospective Case Control Study British Journal of Dermatology 161 78 84 2009

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Reference 2 US Pharmacopeia 31 National Formulary 26 US Pharmacopeial Convention Inc MD p 3547 2009 ZnO

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Reference 20 Green A et al Daily Sunscreen Application and Betacarotene Supplementation in Prevention of Basal Cell and Squamous Cell Carcinomas of the Skin A Randomized Controlled Trial The Lancet 354 723 729 1999

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Reference 21 van der Pols J C et al Prolonged Prevention of Squamous Cell Carcinoma of the Skin by Regular Sunscreen Use Cancer Epidemiology Biomarkers and Prevention 15 2546 2548 2006

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Reference 22 Habif et al Premalignant and Malignant Nonmelanoma Skin Tumors

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Reference 23 Araki K et al Incidence of Skin Cancers and Precancerous Lesions in Japanese Risk Factors and Prevention Journal of Epidemiology 9 S14 S21 1999

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Reference 24 Darlington S et al A Randomized Controlled Trial to Assess Sunscreen Application and Beta Carotene Supplementation in the Prevention of Solar Keratoses Archives of Dermatology 139 451 455 2003

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Reference 25 Naylor M F et al High Sun Protection Factor Sunscreens in the Suppression of Actinic Neoplasia Archives of Dermatology 131 170 175 1995

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Reference 26 Thompson S C et al Reduction of Solar Keratoses by Regular Sunscreen Use New England Journal of Medicine 329 1147 115 1 1993

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Reference 27 Gallagher R P et al Broad Spectrum Sunscreen Use and the Development of New Nevi in White Children A Randomized Controlled Trial The Journal of the American Medical Association 283 2955 2960 2000

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Reference 28 Lee T K et al Site-Specific Protective Effect of Broad-Spectrum Sunscreen on Nevus Development Among White Schoolchildren in a Randomized Trial Journal of the American Academy of Dermatology 52 786 792 2005

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Reference 29 Seite S and A Fourtanier The Benefit of Daily Photoprotection Journal of the American Academy of Dermatology 58 S160 S166 2008

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Reference 3 US Pharmacopeia 31 National Formulary 26 US Pharmacopeial Convention Inc MD p 3548 2009 ZnO neutral

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Reference 30 Fourtanier A et al Protection of Skin Biological Targets by Different Types of Sunscreens Photodematology Photoimmunology and Photomedicine 22 22 32 2006

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Reference 31 Young A R et al The Detrimental Effects of Daily Sub Erythemal Exposure on Human Skin In Vivo Can Be Prevented by a Daily Care Broad Spectrum Sunscreen Journal of Investigative Dermatology 127 975 978 2007

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Reference 32 Moyal D D and A M Fourtanier Broad-Spectrum Sunscreens Provide Better Protection From Solar Ultraviolet Simulated Radiation and Natural Sunlight Induced Immunosuppression In Human Beings Journal of the American Academy Dermatology 58 S149 54 2008

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Reference 33 Label Information for Alli Weight Loss Aid

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Reference 34 Your Guide to Lowering Your Cholesterol with TLC Therapeutic Lifestyle Changes

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Reference 35 Lipitor in Physicians Desk Reference

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Reference 36 The Risks of Tanning October 21 2009

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Reference 37 Dowdy et al Indoor Tanning Injuries An Evaluation of FDA Adverse Event Reporting Data

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Reference 38 Holick et al Vitamin D Deficiency A Worldwide Problem with Health Consequences

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Reference 39 Cable News Network Vitamin D is Hot Heres How to Get it October 31 2008

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Reference 4 Nash J F et al Ultraviolet A Radiation Testing and Labeling for Sunscreen Products Dermatologic Clinics 24 63 74 2006

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Reference 40 Holick Sunlight UV Radiation Vitamin D and Skin Cancer How Much Sunlight do we Need

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Reference 41 Maxwell Seasonal Variation in Vitamin D

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Reference 42 Salih Effect of Clothing Varieties on Solar Photosynthesis of Previtamin D3 An in Vitro Study

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Reference 43 Webb Who What Where and When Influences on Cutaneous Vitamin D Synthesis

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Reference 44 Institute of Medicine Vitamin D in Dietary Reference Intakes For Calcium Phosphorus Magnesium Vitamin D And Flouride National

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Reference 46 Matsuoka et al Sunscreens Suppress Cutaneous Vitamin D3 Synthesis

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Reference 47 Matsuoka et al Chronic Sunscreen Use Decreases Circlulating Concentrations of 25 Hydroxyvitamin D A Preliminary Study

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Reference 48 Marks et al The Effect of Regular Sunscreen Use on Vitamin D Levels in an Australian Population Results of a Randomized Controlled Trial

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Reference 49 Farrerons et al Clinically Prescribed Sunscreen Sun Protection Factor 15 Does not Decrease Serum Vitamin D Concentration Sufficiently Either to Induce Changes in Parathyroid Function or in Metabolic Markers

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Reference 5 Sayre R. M et al Commentary on UVB SPF the SPF Labels of Sunscreen Products Convey More Than Just UVB Protection Photodermatology Photoimmunology Photomedicine, 24 218 220, 2008

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Reference 50 Kimlin et al Does a High UV Environment Ensure Adequate Vitamin D Status

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Reference 51 Cusack et al Photoprotective Behavior and Sunscreen Use Impact on Vitamin D Levels in Cutaneous Lupus Erythematosus

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Reference 52 Hoesl et al Vitamin D Levels of XP Patients Under Stringent Sun Protection

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Reference 53 Zerwekh Blood Biomarkers of Vitamin D Status

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Reference 54 The American Academy of Dermatology Sun Protection for Children February 1 2009

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Reference 55 The American Academy of Dermatology Actinic Keratoses February 1 2009

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Reference 56 The American Academy of Dermatology The Sun and Your Skin February 1 2009

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Reference 58 The American Academy of Dermatology Skin Cancer February 1 2009

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Reference 59 Centers for Disease Control and Prevention Sunscreen for Your Sun Day October 23 2009

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Reference 6 Vainio H and F Bianchini Cancer Preventive Effects of Sunscreens in IARC Handbooks of Cancer Prevention Volume 5 Sunscreens, IARC Lyon FR 69 124 2001

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Reference 60 Sunwise Program Action Steps for Sun Safety February 1 2009

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Reference 61 Wright et al Mechanisms of Sunscreen Failure

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Reference 62 Rigel American Academy of Dermatologys Melanoma Skin Cancer Detection and Prevention Month Press Release April 25 2001

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Reference 63 European Cosmetic Toiletry and Perfumery Association COLIPA JCIA CTFA SA CTFA Sun Protection Factor Test Method 1994

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Reference 64 European Cosmetic Toiletry and Perfumery Association COLIPA JCIA CTFA SA CTFA International Sun Protection Factor SPF Test Method 2006

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Reference 65 Standards Australia and Standards New Zealand Australian New Zealand Standard Sunscreen Products Evaluation and Classification

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Reference 66 Health Canada Category IV Monograph Sunburn Protectants Procedure for Determining an SPF 2002

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Reference 67 Korea Food and Drug Administration Korean Measurement Standards for UV Protection Efficacy 001

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Reference 68 Bimczok R et al Influence of Applied Quantity of Sunscreen Products on the Sun Protection Factor A Multicenter Study Organized by the DGK Task Force Sun Protection

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Reference 69 COLIPA The European Cosmetics association Method for the In Vitro Determination of UVA Protection Provided by Sunscreen Products COLIPA Guidelines 2007a

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Reference 7 Commission Recommendation of 22 September 2006 on the Efficacy of Sunscreen Products and the Claims Made Relating Thereto Official Journal of the European Union L265 49 39 43 2006

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Reference 70 Ferrero L et al Importance of Substrate Roughness for In Vitro Sun Protection Assessment IFSCC Magazine 9 97108 2006

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Reference 71 Sayre R M and J C Dowdy Photostability Testing of Avobenzone Cosmetics and Toiletries 114 8591 1999

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Reference 72 National Cancer Institute Skin Cancer April 17 2009

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Reference 73 National Cancer Institute Surveillance Epidemiology and End Results Melanoma of the Skin November 10 2010

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Reference 74 Bickers DR et al The Burden of Skin Diseases 2004 Journal of the American Academy of Dermatology 55 490 500 2006

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Reference 75 Freedberg KA et al Screening for Mealignant Melanoma A Cost Effective Analysis Journal of the American Academy of Dermatology 41 738 745 1999

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Reference 76 Arias E BL Rostron and B Tejada Vera United States Life tables 2005 National Vital Statistics Reports 58 1 132 2010

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Reference 77 Lewis KG and MA Weinstock Nonmelanoma Skin Cancer Mortality 1988 2000 Archives of Dermatology 140 837 842 2004

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Reference 78 Nolan RC M T L Chan and PJ Heenan A Clinicopathologic Review of Lethal Nonmelanoma Skin Cancers in Western Australia Journal of the American Academy of Dermatology 52 101 108 2005

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Reference 79 Girschik J et al Deaths from Non Melanoma Skin Cancer in Western Australia Cancer Causes and Control 19 879 885 2008

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Reference 8 Document No. FDA 1978 N 0018 0692 in Docket No. FDA 1978N 0018 9 Calvacca L Screening the New Sunscreens Working Woman 15 120 123 1990

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Reference 80 Eastern Research Group 2010 Sunscreen Drug Formulations for Over the Counter Human Use Task Order No 21 Contract No 223 03 8500

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Reference 81 RTI International FDA Labeling Cost Model Final Report prepared by Mary Muth Erica Gledhill and Shawn Karns RTI Prepared for Amber Jessup FDA Center for Food Safety and Applied Nutrition Revised January 2003

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Reference 82 Sunscreen Market Analysis The Evolution and Use of UVA 1 Actives The Proctor and Gamble Company Sharon Woods Technical Center Cincinatti OH 2004

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Reference 9 Calvacca, L Screening the New Sunscreens Working Woman 15 120 123 1990

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References 1 thru 82 FDA 1978 N 0018 formerly Docket 1978N 0038

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Refernce 45 Wolpowitz et al The Vitamin D Questions How Much Do You Need And How Should You Get It

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See Reference 44

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Comments

   
Total: 3
Japan Cosmetic Industry Assocation - Comment
Posted: 08/12/2011     ID: FDA-1978-N-0018-0703

Lott Research, Inc - Comment
Posted: 09/12/2011     ID: FDA-1978-N-0018-0704

ITW Dyymon (An Illinois Tool Works Company) - Comment
Posted: 05/30/2012     ID: FDA-1978-N-0018-0747

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