Development, Evaluation, and Regulatory Aspects

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1 Development, Evaluation, and Regulatory Aspects Second Edition, Revised and Expanded edited by Nicholas J. Lowe Skin Research Foundation of California Santa Monica, California UCLA School of Medicine Los Angeles, California KATO Worldwide, Ltd./Nickstadt-Moeller Mt. Vernon, New York MadhuA.Pathak Harvard Medical School and Massachusetts General Hospital Boston, Massachusetts Marcel Dekker, Inc. New York*Basel*Hong Kong

2 About the Series (Eric Jungermann) Preface Contributors iii vii xiii I. INTRODUCTION 1. Evolution of Modern Sunscreen Chemicals 2. Sunscreens: Rationale for Use to Reduce Photodamage 35 and Phototoxicity Nicholas J. Lowe and Josia Friedlander 3. Photoprotection Against Harmful Effects of Solar UVB and 59 UVA Radiation: An Update Madhu A. Pathak ix

3 H. PHOTOBIOLOGICAL ASPECTS 4. Biological Effects of Sunlight 83 John H. Epstein 5. Exposure to Low Levels of Ultraviolet Light B or 101 Ultraviolet Light A Induces Cutaneous Photodamage in Human Skin David P. Meyers, Nicholas J. Lowe, and Ian R. Scott 6. Ultraviolet Radiation-Induced Skin Aging 117 Lorraine H. Kligman and Albert M. Kligman 7. Antioxidants and Carotenoids as Potential Photoprotectants 139 Homer S. Black and Betty Rajan 8. Reactive Oxygen Species and Antioxidant Protection 155 in Photodermatology Douglas Darr and Sheldon R. Pinnell 9. Dosimetry of Ultraviolet Radiation 175 Brian L. Diffey 10. Reduction of Actinic Keratoses by Sunscreens 189 Robin Marks III. REGULATORY ASPECTS 11. Regulatory Aspects of Sunscreens in the United States 201 Emalee G. Murphy 12. Regulatory Aspects of Sunscreens in Europe 215 Angela Janousek 13. The Sunscreen Industry in Australia: Past, Present, and Future 227 Gordon A. Groves 14. The Sunscreen Industry in Japan: Past, Present, and Future 241 Minoru Fukuda and Masako Naganuma IV. SUNSCREEN INGREDIENTS AND FORMULATIONS 15. The Chemistry of Sunscreens 263

4 xi 16. Sunscreen Products: Formulation and Regulatory Considerations 285 Kenneth Klein 17. Particulate Sun Blocks: General Principles 313 David Fairhurst and Mark A. Mitchnick 18. Broad-Spectrum Physical Sunscreens: Titanium Dioxide 353 and Zinc Oxide Michael W. Anderson, Julian P. Hewitt, and Stephen R. Spruce 19. Photoprotection of Hair: A Review 399 Arthur C. W. Georgalas 20. Melanins 421 Miles R. Chedekel and Lisa Zeise 21. Sunscreens and Hair 445 Sergio Nacht Methoxypsoralen-Containing Sunscreens 461 Antony R. Young 23. Tanning Accelerators 473 James M. Wilmott, Michele C. Duggan, and Alexander P. Znaiden V. BIOLOGICAL EVALUATION OF SUNSCREEN PRODUCTS 24. Sun Protection Factor Determination in the United States 499 Molly E. Griffin, Teresa D. Bourget, and Nicholas J. Lowe 25. European Guidelines (COLIPA) for Evaluation of Sun 513 Protection Factors Jack Ferguson 26. Ultraviolet A Claims and Testing Procedures for 527 OTC Sunscreens: A Summary and Review Nicholas J. Lowe 27. An Evaluation of Methods for Measuring Sunscreen 537 Ultraviolet A Protection Factors Joseph W. Stanfield, Susan H. Edmonds, and Patricia P. Agin

5 xii 28. Persistent Pigment-Darkening Response as a Method for 559 Evaluation of Ultraviolet A Protection Assays Alain Chardon, Dominique Moyal, and C. Hourseau 29. Sunscreens: Effects of Amounts of Application of Sun 583 Protection Factors Annette Gottlieb, Teresa D. Bourget, and Nicholas J. Lowe 30. Indices of Protection from In Vitro Assay of Sunscreens 589 Brian L. Diffey 31. Noninvasive In Vivo Determination of Sunscreen Ultraviolet 601 A Protection Factors Using Diffuse Reflectance Spectroscopy Robert Gillies and Nikiforos Kollias 32. Polymorphous Light Eruption: Its Reproduction 611 and Prevention by Sunscreens Dominique Moyal and O. Binet 33. Ultraviolet Protection Offered by Clothing: An In Vitro 619 and In Vivo Assessment of Clothing Fabrics Nicholas J. Lowe, Teresa D. Bourget, Shaun Hughes, and Robert M. Sayre 34. Contact Sensitization and Photocontact Sensitization 631 of Sunscreening Agents Jens O. Funk, Sydney H. Dromgoole, and Howard I. Maibach VI. CHEMICAL EVALUATION OF SUNSCREEN PRODUCTS 35. Quality Control of Sunscreens Modern Analytical Techniques in the Sunscreen Industry 677, Peter M. Griffin, and Gideon I. Andemicael 37. Interpretation and Evaluation: Spectroscopic Data 709 from Sunscreens, Peter M. Griffin, Gideon I. Andemicael, and Lisa E. Paloympis Index 763

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