Refeence 57 The American Academy of
Dermatology The Darker Side of Tanning February 1 2009
View Attachment:
Title: Refeence 57 The American Academy of
Dermatology The Darker Side of Tanning February 1 2009
Reference 1 FDA List of Docket Submissions
Addressed in This Rule Organized by Issue Sunscreen FR Docket References FR 2 15 11
View Attachment:
Title: Reference 1 FDA List of Docket Submissions
Addressed in This Rule Organized by Issue Sunscreen FR Docket References FR 2 15 11
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
View Attachment:
Title: 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
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
View Attachment:
Title: 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
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.
View Attachment:
Title: 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.
Reference 13 Armstrong B K et al Sun
Exposure and Skin Cancer Australasian Journal of Dermatology 38 S1 S6 1997
View Attachment:
Title: Reference 13 Armstrong B K et al Sun
Exposure and Skin Cancer Australasian Journal of Dermatology 38 S1 S6 1997
Reference 14 World Health Organization IARC IARC Monographs on the Evaluation of
Carcinogenic Risks to Humans Vol 55
Solar and Ultraviolet Radiation
View Attachment:
Title: Reference 14 World Health Organization IARC IARC Monographs on the Evaluation of
Carcinogenic Risks to Humans Vol 55
Solar and Ultraviolet Radiation
Reference 15 Report on Carcinogens Eleventh Edition
View Attachment:
Title: Reference 15 Report on Carcinogens Eleventh Edition
Reference 16 Rabe J et al Photoaging
Mechanisms and Repair Journal of the
American Academy of Dermatology
55 1 19 2006
View Attachment:
Title: Reference 16 Rabe J et al Photoaging
Mechanisms and Repair Journal of the
American Academy of Dermatology
55 1 19 2006
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
View Attachment:
Title: 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
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
View Attachment:
Title: 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
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
View Attachment:
Title: 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
Reference 2 US Pharmacopeia 31 National Formulary 26 US Pharmacopeial Convention Inc MD p 3547 2009 ZnO
View Attachment:
Title: Reference 2 US Pharmacopeia 31 National Formulary 26 US Pharmacopeial Convention Inc MD p 3547 2009 ZnO
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
View Attachment:
Title: 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
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
View Attachment:
Title: 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
Reference 22 Habif et al Premalignant and Malignant Nonmelanoma Skin Tumors
View Attachment:
Title: Reference 22 Habif et al Premalignant and Malignant Nonmelanoma Skin Tumors
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
View Attachment:
Title: 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
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
View Attachment:
Title: 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
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
View Attachment:
Title: 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
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
View Attachment:
Title: 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
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
View Attachment:
Title: 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
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
View Attachment:
Title: 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
Reference 29 Seite S and A Fourtanier The
Benefit of Daily Photoprotection Journal of the American Academy of Dermatology 58 S160 S166 2008
View Attachment:
Title: Reference 29 Seite S and A Fourtanier The
Benefit of Daily Photoprotection Journal of the American Academy of Dermatology 58 S160 S166 2008
Reference 3 US Pharmacopeia 31 National Formulary 26 US Pharmacopeial Convention Inc MD p 3548 2009 ZnO neutral
View Attachment:
Title: Reference 3 US Pharmacopeia 31 National Formulary 26 US Pharmacopeial Convention Inc MD p 3548 2009 ZnO neutral
Reference 30 Fourtanier A et al Protection of Skin Biological Targets by Different Types of Sunscreens
Photodematology Photoimmunology
and Photomedicine 22 22 32 2006
View Attachment:
Title: Reference 30 Fourtanier A et al Protection of Skin Biological Targets by Different Types of Sunscreens
Photodematology Photoimmunology
and Photomedicine 22 22 32 2006
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
View Attachment:
Title: 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
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
View Attachment:
Title: 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
Reference 33 Label Information for Alli
Weight Loss Aid
View Attachment:
Title: Reference 33 Label Information for Alli
Weight Loss Aid
Reference 34 Your Guide to Lowering Your
Cholesterol with TLC Therapeutic Lifestyle Changes
View Attachment:
Title: Reference 34 Your Guide to Lowering Your
Cholesterol with TLC Therapeutic Lifestyle Changes
Reference 35 Lipitor in Physicians Desk
Reference
View Attachment:
Title: Reference 35 Lipitor in Physicians Desk
Reference
Reference 36 The Risks of Tanning October 21 2009
View Attachment:
Title: Reference 36 The Risks of Tanning October 21 2009
Reference 37 Dowdy et al Indoor
Tanning Injuries An Evaluation of FDA
Adverse Event Reporting Data
View Attachment:
Title: Reference 37 Dowdy et al Indoor
Tanning Injuries An Evaluation of FDA
Adverse Event Reporting Data
Reference 38 Holick et al Vitamin D Deficiency A Worldwide Problem with Health Consequences
View Attachment:
Title: Reference 38 Holick et al Vitamin D Deficiency A Worldwide Problem with Health Consequences
Reference 39 Cable News Network Vitamin D
is Hot Heres How to Get it October 31 2008
View Attachment:
Title: Reference 39 Cable News Network Vitamin D
is Hot Heres How to Get it October 31 2008
Reference 4 Nash J F et al Ultraviolet A
Radiation Testing and Labeling for Sunscreen Products Dermatologic Clinics 24 63 74 2006
View Attachment:
Title: Reference 4 Nash J F et al Ultraviolet A
Radiation Testing and Labeling for Sunscreen Products Dermatologic Clinics 24 63 74 2006
Reference 40 Holick Sunlight UV Radiation Vitamin D and Skin Cancer How Much Sunlight do we Need
View Attachment:
Title: Reference 40 Holick Sunlight UV Radiation Vitamin D and Skin Cancer How Much Sunlight do we Need
Reference 41 Maxwell Seasonal
Variation in Vitamin D
View Attachment:
Title: Reference 41 Maxwell Seasonal
Variation in Vitamin D
Reference 42 Salih Effect of Clothing
Varieties on Solar Photosynthesis of
Previtamin D3 An in Vitro Study
View Attachment:
Title: Reference 42 Salih Effect of Clothing
Varieties on Solar Photosynthesis of
Previtamin D3 An in Vitro Study
Reference 43 Webb Who What Where and When Influences on Cutaneous Vitamin D Synthesis
View Attachment:
Title: Reference 43 Webb Who What Where and When Influences on Cutaneous Vitamin D Synthesis
Reference 44 Institute of Medicine Vitamin D in Dietary Reference Intakes For Calcium Phosphorus Magnesium Vitamin D And Flouride National
View Attachment:
Title: Reference 44 Institute of Medicine Vitamin D in Dietary Reference Intakes For Calcium Phosphorus Magnesium Vitamin D And Flouride National
Reference 46 Matsuoka et al Sunscreens Suppress Cutaneous Vitamin D3 Synthesis
View Attachment:
Title: Reference 46 Matsuoka et al Sunscreens Suppress Cutaneous Vitamin D3 Synthesis
Reference 47 Matsuoka et al Chronic
Sunscreen Use Decreases Circlulating
Concentrations of 25 Hydroxyvitamin D
A Preliminary Study
View Attachment:
Title: Reference 47 Matsuoka et al Chronic
Sunscreen Use Decreases Circlulating
Concentrations of 25 Hydroxyvitamin D
A Preliminary Study
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
View Attachment:
Title: 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
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
View Attachment:
Title: 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
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
View Attachment:
Title: 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
Reference 50 Kimlin et al Does a High UV
Environment Ensure Adequate Vitamin
D Status
View Attachment:
Title: Reference 50 Kimlin et al Does a High UV
Environment Ensure Adequate Vitamin
D Status
Reference 51 Cusack et al Photoprotective Behavior and Sunscreen Use Impact on Vitamin D Levels in Cutaneous Lupus Erythematosus
View Attachment:
Title: Reference 51 Cusack et al Photoprotective Behavior and Sunscreen Use Impact on Vitamin D Levels in Cutaneous Lupus Erythematosus
Reference 52 Hoesl et al Vitamin D Levels of XP Patients Under Stringent Sun Protection
View Attachment:
Title: Reference 52 Hoesl et al Vitamin D Levels of XP Patients Under Stringent Sun Protection
Reference 53 Zerwekh Blood Biomarkers
of Vitamin D Status
View Attachment:
Title: Reference 53 Zerwekh Blood Biomarkers
of Vitamin D Status
Reference 54 The American Academy of
Dermatology Sun Protection for Children February 1 2009
View Attachment:
Title: Reference 54 The American Academy of
Dermatology Sun Protection for Children February 1 2009
Reference 55 The American Academy of
Dermatology Actinic Keratoses February 1 2009
View Attachment:
Title: Reference 55 The American Academy of
Dermatology Actinic Keratoses February 1 2009
Reference 56 The American Academy of
Dermatology The Sun and Your Skin February 1 2009
View Attachment:
Title: Reference 56 The American Academy of
Dermatology The Sun and Your Skin February 1 2009
Reference 58 The American Academy of
Dermatology Skin Cancer February 1 2009
View Attachment:
Title: Reference 58 The American Academy of
Dermatology Skin Cancer February 1 2009
Reference 59 Centers for Disease Control and
Prevention Sunscreen for Your Sun
Day October 23 2009
View Attachment:
Title: Reference 59 Centers for Disease Control and
Prevention Sunscreen for Your Sun
Day October 23 2009
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
View Attachment:
Title: 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
Reference 60 Sunwise Program Action Steps
for Sun Safety February 1
2009
View Attachment:
Title: Reference 60 Sunwise Program Action Steps
for Sun Safety February 1
2009
Reference 61 Wright et al Mechanisms of Sunscreen Failure
View Attachment:
Title: Reference 61 Wright et al Mechanisms of Sunscreen Failure
Reference 62 Rigel American Academy of
Dermatologys Melanoma Skin Cancer
Detection and Prevention Month Press
Release April 25 2001
View Attachment:
Title: Reference 62 Rigel American Academy of
Dermatologys Melanoma Skin Cancer
Detection and Prevention Month Press
Release April 25 2001
Reference 63 European Cosmetic Toiletry and
Perfumery Association COLIPA JCIA
CTFA SA CTFA Sun Protection
Factor Test Method 1994
View Attachment:
Title: Reference 63 European Cosmetic Toiletry and
Perfumery Association COLIPA JCIA
CTFA SA CTFA Sun Protection
Factor Test Method 1994
Reference 64 European Cosmetic Toiletry and Perfumery Association COLIPA JCIA
CTFA SA CTFA International Sun Protection Factor SPF Test Method
2006
View Attachment:
Title: Reference 64 European Cosmetic Toiletry and Perfumery Association COLIPA JCIA
CTFA SA CTFA International Sun Protection Factor SPF Test Method
2006
Reference 65 Standards Australia and Standards New Zealand Australian New Zealand Standard Sunscreen Products
Evaluation and Classification
View Attachment:
Title: Reference 65 Standards Australia and Standards New Zealand Australian New Zealand Standard Sunscreen Products
Evaluation and Classification
Reference 66 Health Canada Category IV
Monograph Sunburn Protectants Procedure for Determining an SPF 2002
View Attachment:
Title: Reference 66 Health Canada Category IV
Monograph Sunburn Protectants Procedure for Determining an SPF 2002
Reference 67 Korea Food and Drug
Administration Korean Measurement
Standards for UV Protection Efficacy 001
View Attachment:
Title: Reference 67 Korea Food and Drug
Administration Korean Measurement
Standards for UV Protection Efficacy 001
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
View Attachment:
Title: 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
Reference 69 COLIPA The European Cosmetics association Method for the In Vitro
Determination of UVA Protection
Provided by Sunscreen Products
COLIPA Guidelines 2007a
View Attachment:
Title: Reference 69 COLIPA The European Cosmetics association Method for the In Vitro
Determination of UVA Protection
Provided by Sunscreen Products
COLIPA Guidelines 2007a
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
View Attachment:
Title: 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
Reference 70 Ferrero L et al Importance of Substrate Roughness for In Vitro Sun
Protection Assessment IFSCC
Magazine 9 97108 2006
View Attachment:
Title: Reference 70 Ferrero L et al Importance of Substrate Roughness for In Vitro Sun
Protection Assessment IFSCC
Magazine 9 97108 2006
Reference 71 Sayre R M and J C Dowdy
Photostability Testing of Avobenzone
Cosmetics and Toiletries 114 8591
1999
View Attachment:
Title: Reference 71 Sayre R M and J C Dowdy
Photostability Testing of Avobenzone
Cosmetics and Toiletries 114 8591
1999
Reference 72 National Cancer Institute Skin
Cancer April 17 2009
View Attachment:
Title: Reference 72 National Cancer Institute Skin
Cancer April 17 2009
Reference 73 National Cancer Institute
Surveillance Epidemiology and End
Results Melanoma of the Skin November 10 2010
View Attachment:
Title: Reference 73 National Cancer Institute
Surveillance Epidemiology and End
Results Melanoma of the Skin November 10 2010
Reference 74 Bickers DR et al The Burden
of Skin Diseases 2004 Journal of the
American Academy of Dermatology
55 490 500 2006
View Attachment:
Title: Reference 74 Bickers DR et al The Burden
of Skin Diseases 2004 Journal of the
American Academy of Dermatology
55 490 500 2006
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
View Attachment:
Title: 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
Reference 76 Arias E BL Rostron and B
Tejada Vera United States Life tables
2005 National Vital Statistics Reports
58 1 132 2010
View Attachment:
Title: Reference 76 Arias E BL Rostron and B
Tejada Vera United States Life tables
2005 National Vital Statistics Reports
58 1 132 2010
Reference 77 Lewis KG and MA Weinstock
Nonmelanoma Skin Cancer Mortality
1988 2000 Archives of Dermatology
140 837 842 2004
View Attachment:
Title: Reference 77 Lewis KG and MA Weinstock
Nonmelanoma Skin Cancer Mortality
1988 2000 Archives of Dermatology
140 837 842 2004
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
View Attachment:
Title: 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
Reference 79 Girschik J et al Deaths from
Non Melanoma Skin Cancer in Western Australia Cancer Causes and Control
19 879 885 2008
View Attachment:
Title: Reference 79 Girschik J et al Deaths from
Non Melanoma Skin Cancer in Western Australia Cancer Causes and Control
19 879 885 2008
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
View Attachment:
Title: 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
Reference 80 Eastern Research Group 2010
Sunscreen Drug Formulations for Over the
Counter Human Use Task Order
No 21 Contract No 223 03 8500
View Attachment:
Title: Reference 80 Eastern Research Group 2010
Sunscreen Drug Formulations for Over the
Counter Human Use Task Order
No 21 Contract No 223 03 8500
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
View Attachment:
Title: 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
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
View Attachment:
Title: 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
Reference 9 Calvacca, L Screening the New
Sunscreens Working Woman 15 120
123 1990
View Attachment:
Title: Reference 9 Calvacca, L Screening the New
Sunscreens Working Woman 15 120
123 1990
References 1 thru 82 FDA 1978 N 0018 formerly Docket 1978N 0038
View Attachment:
Title: References 1 thru 82 FDA 1978 N 0018 formerly Docket 1978N 0038
Refernce 45 Wolpowitz et al The Vitamin D Questions How Much Do You Need And How Should You Get It
View Attachment:
Title: Refernce 45 Wolpowitz et al The Vitamin D Questions How Much Do You Need And How Should You Get It
Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-the-Counter Human Use
Details Information
Attachments:
Refeence 57 The American Academy of Dermatology The Darker Side of Tanning February 1 2009
View Attachment:Reference 1 FDA List of Docket Submissions Addressed in This Rule Organized by Issue Sunscreen FR Docket References FR 2 15 11
View Attachment: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
View Attachment: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
View Attachment: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.
View Attachment:Reference 13 Armstrong B K et al Sun Exposure and Skin Cancer Australasian Journal of Dermatology 38 S1 S6 1997
View Attachment:Reference 14 World Health Organization IARC IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Vol 55 Solar and Ultraviolet Radiation
View Attachment:Reference 15 Report on Carcinogens Eleventh Edition
View Attachment:Reference 16 Rabe J et al Photoaging Mechanisms and Repair Journal of the American Academy of Dermatology 55 1 19 2006
View Attachment: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
View Attachment: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
View Attachment: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
View Attachment:Reference 2 US Pharmacopeia 31 National Formulary 26 US Pharmacopeial Convention Inc MD p 3547 2009 ZnO
View Attachment: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
View Attachment: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
View Attachment:Reference 22 Habif et al Premalignant and Malignant Nonmelanoma Skin Tumors
View Attachment: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
View Attachment: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
View Attachment: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
View Attachment: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
View Attachment: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
View Attachment: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
View Attachment:Reference 29 Seite S and A Fourtanier The Benefit of Daily Photoprotection Journal of the American Academy of Dermatology 58 S160 S166 2008
View Attachment:Reference 3 US Pharmacopeia 31 National Formulary 26 US Pharmacopeial Convention Inc MD p 3548 2009 ZnO neutral
View Attachment:Reference 30 Fourtanier A et al Protection of Skin Biological Targets by Different Types of Sunscreens Photodematology Photoimmunology and Photomedicine 22 22 32 2006
View Attachment: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
View Attachment: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
View Attachment:Reference 33 Label Information for Alli Weight Loss Aid
View Attachment:Reference 34 Your Guide to Lowering Your Cholesterol with TLC Therapeutic Lifestyle Changes
View Attachment:Reference 35 Lipitor in Physicians Desk Reference
View Attachment:Reference 36 The Risks of Tanning October 21 2009
View Attachment:Reference 37 Dowdy et al Indoor Tanning Injuries An Evaluation of FDA Adverse Event Reporting Data
View Attachment:Reference 38 Holick et al Vitamin D Deficiency A Worldwide Problem with Health Consequences
View Attachment:Reference 39 Cable News Network Vitamin D is Hot Heres How to Get it October 31 2008
View Attachment:Reference 4 Nash J F et al Ultraviolet A Radiation Testing and Labeling for Sunscreen Products Dermatologic Clinics 24 63 74 2006
View Attachment:Reference 40 Holick Sunlight UV Radiation Vitamin D and Skin Cancer How Much Sunlight do we Need
View Attachment:Reference 41 Maxwell Seasonal Variation in Vitamin D
View Attachment:Reference 42 Salih Effect of Clothing Varieties on Solar Photosynthesis of Previtamin D3 An in Vitro Study
View Attachment:Reference 43 Webb Who What Where and When Influences on Cutaneous Vitamin D Synthesis
View Attachment:Reference 44 Institute of Medicine Vitamin D in Dietary Reference Intakes For Calcium Phosphorus Magnesium Vitamin D And Flouride National
View Attachment:Reference 46 Matsuoka et al Sunscreens Suppress Cutaneous Vitamin D3 Synthesis
View Attachment:Reference 47 Matsuoka et al Chronic Sunscreen Use Decreases Circlulating Concentrations of 25 Hydroxyvitamin D A Preliminary Study
View Attachment: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
View Attachment: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
View Attachment: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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View Attachment: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
View Attachment: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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View Attachment: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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View Attachment: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
View Attachment:Reference 80 Eastern Research Group 2010 Sunscreen Drug Formulations for Over the Counter Human Use Task Order No 21 Contract No 223 03 8500
View Attachment: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
View Attachment: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
View Attachment:Reference 9 Calvacca, L Screening the New Sunscreens Working Woman 15 120 123 1990
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View Attachment:Refernce 45 Wolpowitz et al The Vitamin D Questions How Much Do You Need And How Should You Get It
View Attachment:See Reference 44
View Attachment:Comments
Posted: 08/12/2011 ID: FDA-1978-N-0018-0703
Posted: 09/12/2011 ID: FDA-1978-N-0018-0704
Posted: 05/30/2012 ID: FDA-1978-N-0018-0747
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