Sunscreens: Regulations and Commercial Development

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ISBN: 9780824757946 | 0824757947
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Copyright: 3/17/2005

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The increasing number of individuals affected by sun damage has inspired cosmetic chemists to research new vehicles for improved protection against UVA and UVB rays. This volume collects the latest research and perspectives on sunscreen development, assessment, formulation, and quality control from leading authorities in academia, industry, and the regulatory and medical communities-describing the evolution, chemistry, evaluation, and regulation of sunscreens in the 21st century for improved skin protection.

Introduction

Sunscreen Evolution

(16)

Nadim A. Shaath

Historical Background

(1)

Skin Cancer and the Solar Spectrum

(1)

Sunscreen Products

(1)

Issues and Challenges Facing the Sunscreen Industry

(6)

Regulatory and Safety Issues

(1)

Sun Protection Factor

(1)

The Region in the UV Spectrum

(1)

Water Resistance

(1)

Photostability and Photoreactivity

(1)

Safety and Stability

(1)

Manufacturing and Quality Control

(1)

Cosmetic Formulation Issues

(1)

Formula Types

(1)

Formula Optimization

(1)

Active Ingredients

(1)

Other Ingredients

(2)

Marketing Issues

(1)

Sunscreen Products for the 21st Century

(3)

UV Filters

(1)

Natural Ingredients

(1)

Biologically Active Ingredients

(1)

Cosmetic Formulations

(1)

Conclusions

(1)

References

(3)

Photoprotection

(26)

Christopher G. Nelson, Jr.

Why Do We Need Photoprotection?

(1)

The Solar Spectrum

(1)

Acute Solar Damage

(2)

Introduction

(1)

Mechanism of Acute Photodamage

(1)

Histology of Acute Photodamage

(1)

Chronic Solar Damage

(1)

Introduction

(1)

Mechanism of Chronic Damage

(1)

Histology of Chronic Damage

(1)

Other Effects of Photoexposure

(3)

Photosensitive Reaction

(2)

Phototoxicity

(1)

Photoallergy

(1)

Photosensitivity Skin Disorders

(3)

Lupus Erythematosus (290--330 nm)

(1)

Xeroderma Pigmentosum (290--340 nm)

(1)

Chronic Actinic Dermatitis (290--360 nm)

(2)

Polymorphous Light Eruption (290--365 nm)

(1)

Hydroa Vacciniforme (290--400 nm)

(1)

Persistent Light Reaction (290--400 nm)

(1)

Solar Urticaria (290--515 nm)

(1)

Porphyrias (400--410 nm)

(1)

Miscellaneous Dermatoses

(1)

Carcinogenesis Related to Photoexposure

(3)

Mechanism of Carcinogenesis

(1)

Opportunities to Interrupt the Pathway

(1)

Initiation

(1)

Promotion

(2)

Progression

(1)

Immunopathology of Skin Cancer---An Apparent Paradox

(1)

Strategies to Block UV Light

(3)

Sun Exposure Avoidance

(1)

Sun Protective Clothing

(2)

Sunscreens

(1)

Sunscreening Agents

(1)

Organic Sunscreening Agents

(1)

Inorganic Sunscreening Agents

(1)

Proper Use of Sunscreens

(1)

Suggestions for the Future

(1)

References

(6)

A Perspective on the Need for Topical Sunscreens

(10)

B. L. Diffey

Observable Cutaneous Effects of Sun Exposure

(2)

Production of Vitamin D

(1)

Tanning

(1)

Sunburn

(1)

Skin Cancer

(1)

Photoaging

(1)

Sunscreen Use and the Sun Protection Factor

(1)

How Large Should the SPF Be to Prevent Sunburn?

(1)

How High Should the SPF Be to Give a Worthwhile Reduction in Lifetime Risk of Skin Cancer?

(1)

Is Daily Use of Sunscreens of Benefit?

(1)

A Strategy for Sunscreen Use

(1)

References

(3)

Safety Considerations for Sunscreens in the USA

(16)

Richard J. Schwen

Requirements for Safety Testing of Sunscreens

(1)

Parameters Affecting Sunscreen Safety

(1)

Safety Programs Required for Sunscreen Products

(1)

Safety Testing Models for Sunscreen Products

(9)

In Vitro Models

(2)

In Vivo Dermal Safety Testing in Animals

(3)

In Vivo Systemic Safety Testing in Animals

(1)

In Vivo Dermal and Systemic Safety Testing in Humans

(2)

Risk Assessment and Safety Testing of Sunscreens

(1)

Conclusion

(1)

References

(3)

Sunprotection: Historical Perspective

(14)

Paolo U. Giacomoni

The Sun and Humans in the Past

(2)

Experimental Evidence of Beneficial and Harmful Effects of Solar Radiation

(1)

UV-B, the Bad Guy

(1)

Experimental Evidence for UV-A Induced Damages

(1)

Why Anti-UV-A Sunscreens?

(1)

Anti-UV-B and Anti-UV-A Sunscreens

(1)

Beyond SPF

(1)

The Future: New Strategies for Defense

(1)

The Future: New Aggressors?

(1)

References

(5)

Regulatory Aspects

The Role of FDA in Sunscreen Regulation

(10)

Matthew R. Holman

Daiva Shetty

Differentiating Drug, Cosmetic, and Drug--Cosmetic Products

(1)

Regulatory Mechanisms for Marketing Sunscreen Drug Products

(2)

New Drug Application

(2)

OTC Drug Monograph System

(1)

Description of the OTC Drug Monograph System

(4)

Advisory Panel Review

(1)

Tentative Final Monograph

(1)

Final Monograph

(1)

Description of an OTC Drug Monograph

(2)

Amending an OTC Drug Monograph

(2)

Citizen Petition

(1)

Time and Extent Application

(2)

The Final Monograph

(22)

Emalee G. Murphy

History and Scope of the Regulation

(5)

Key Provisions of the Final Monograph

101

(3)

Permitted Active Sunscreen Ingredients

101

(1)

Ingredients Listed in 21 CFR 352.10

101

(1)

Active Ingredient Combinations

102

(1)

Sunscreen Active Ingredient Combination Pattern A

102

(1)

Sunscreen Active Ingredient Combination Pattern B

103

(1)

Ingredients for Combination Sunscreen--Skin Protectant Products

103

(1)

Combinations of Sunscreens and Skin Protectant Ingredients

103

(1)

Labeling Requirements

104

(4)

On the Principal Display Panel

105

(1)

In the Drug Facts Panel

106

(2)

Labeling Caveats

108

(3)

Antiaging/Antiphotoaging

109

(1)

Tanning Accelerators, Melanin and Antioxidants

109

(1)

Warnings for Tanning Products without Sunscreens

109

(1)

``Chemical-free'', ``Natural'', and ``PABA-free'' Ingredients

110

(1)

Extended Protection Claims

110

(1)

Freckles and Uneven Skin Tone

110

(1)

Testing Sunscreen Efficacy

111

(1)

What of the Future?

111

(3)

FDA Requests for Information and Comment

112

(2)

Conclusion

114

(3)

Regulatory Aspects of Suncreens in Europe

117

(10)

Romano E. Mascotto

Definition of Ultraviolet Filters

117

(1)

The EEC Directive Published November 28, 1983

118

(6)

Non-EU Countries' Regulatory Status

124

(1)

Sun Protection Measurements

124

(1)

Future

125

(2)

Regulation of Sunscreens in Australia

127

(14)

Malcolm R. Nearn

Introduction

128

(1)

The Regulatory Framework

129

(2)

Test Methods

131

(1)

The Listing Process

132

(1)

New Chemicals

132

(3)

New Excipients (Nonactive Ingredients)

132

(1)

New Sunscreen Actives

133

(2)

Permitted Sunscreens Actives and their Maximum Allowed Dosages

135

(1)

Sunscreens Actives under Review

136

(1)

Licensing of Premises

136

(1)

Labeling of Sunscreens

137

(1)

Mandatory Requirements for Primary Sunscreens

137

(1)

Optional Requirements for Primary Sunscreens

137

(1)

Mandatory Requirements for Secondary Sunscreens

138

(1)

Optional Requirements for Secondary Sunscreens

138

(1)

Advertising of Sunscreens

138

(1)

The Cosmetic/Therapeutic Interface

139

(1)

Example 1

139

(1)

Example 2

139

(1)

Conclusions

140

(1)

Legal and Regulatory Status of Sunscreen Products in Japan

141

(32)

Minoru Fukuda

Masako Naganuma

Outline

142

(1)

Introduction

142

(1)

Japanese Skin Characteristics and Attitude to UV

143

(4)

The Sunscreen Characteristics Desired by Japanese

147

(1)

The Regulation of Sunscreen Products and the Development of UV-Protective Agents

148

(6)

Development of Effectiveness, Labeling, and Testing of Sunscreen Products in Japan

154

(13)

SPF Testing Methods in Japan

154

(3)

Measurement Standards for UV-A Protection Efficacy in Japan

157

(7)

Development of Sunscreen Labeling for UV Protection Efficacy in Japan

164

(3)

Problems for the Future

167

(2)

References

169

(4)

Regulations of Sunscreens Worldwide

173

(26)

David C. Steinberg

Overview of Regulations and Permitted UV Filters

174

(1)

Active Ingredients

175

(1)

The USA

175

(1)

Japan

175

(1)

EU Permitted Filters

176

(1)

Australian Approved UV Filters

176

(1)

Summary of Actives

176

(1)

Approval Process for New Active Ingredients

176

(7)

USA

176

(5)

Japan

181

(1)

European Union

182

(1)

Australia

182

(1)

Testing of Sunscreens

183

(1)

Reference Standards

183

(7)

USA

183

(5)

European Union

188

(2)

Japan

190

(1)

Australia

190

(1)

UV-A Tests

190

(2)

USA

190

(1)

European Union

190

(1)

Japan

191

(1)

Australia

192

(1)

Water Resistance Tests

192

(1)

USA

192

(1)

Australia

192

(1)

The Labeling of Sunscreens

193

(4)

USA

194

(2)

European Union

196

(1)

Australia

196

(1)

Japan

197

(1)

Manufacture of Sunscreens

197

(2)

Sunscreen Products: The Role of the US Pharmacopeia

199

(18)

Lawrence Evans III

Introduction

200

(1)

The US Pharmacopeia

201

(6)

Mission

201

(1)

History

201

(1)

Legal Recognition

201

(1)

United States Pharmacopeia and National Formulary

201

(2)

USP Reference Standards

203

(1)

Standards-Setting Body

203

(1)

Monograph Development and Revision Process

204

(1)

Overview

204

(1)

Contributors

204

(1)

Revision Process

205

(1)

Guideline for Submitting Revisions

205

(2)

Pharmacopeial Forum

207

(1)

USP Monographs for Sunscreen Active Ingredients

207

(3)

USP Monographs for Active Ingredients Identified in 21 CFR 352.10

208

(1)

USP Monographs for Ingredients not Identified in 21 CFR 352.10

209

(1)

Conclusion

210

(1)

Appendix

210

(2)

References

212

(5)

Ultraviolet Filters

The Chemistry of Ultraviolet Filters

217

(22)

Nadim A. Shaath

Introduction

218

(1)

The Electromagnetic Spectrum

218

(2)

Effect of UV Radiation on the Skin

220

(1)

Classification of UV Filters

221

(10)

PABA and p-Aminobenzoates

224

(2)

Salicylates

226

(1)

Cinnamates

227

(1)

Benzophenones

228

(1)

Anthranilates

229

(1)

Dibenzoylmethanes

230

(1)

Camphor Derivatives

230

(1)

Miscellaneous Compounds

231

(1)

Mechanism of Sunscreening Action

231

(4)

Effect of Vehicle on the Efficacy of UV Filters

232

(1)

pH Effects on UV Filters

233

(1)

Effect of Emollients on the Efficacy of UV Filters

233

(2)

Effects on the Extinction Coefficient

235

(1)

The Future of UV Filters

235

(2)

Conclusions

237

(1)

References

238

(1)

Inorganic Ultraviolet Filters

239

(42)

David Schlossman

Yun Shao

Evolution and Perspectives

240

(2)

Evolution of Inorganic Ultraviolet Filters

240

(1)

Titanium Dioxide and Zinc Oxide

241

(1)

Perspectives for Inorganic UV Filters

241

(1)

Physical and Chemical Properties of Titanium Dioxide and Zinc Oxide

242

(6)

General Properties

242

(1)

Titanium Dioxide

242

(1)

Zinc Oxide

243

(1)

Isoelectric Point

244

(1)

Photocatalytic Activity

244

(2)

Glycol Method

246

(1)

Vitamin Method

246

(1)

Optical Behaviors

246

(1)

Scattering

247

(1)

Absorption

247

(1)

Manufacturers of Inorganic Ultraviolet Filters

248

(4)

Production of Micronized Titanium Dioxide

249

(1)

Manufacturers of Micronized Titanium Dioxide

250

(1)

Typical Specifications of Micronized Titanium Dioxide

250

(1)

Production and Manufacturers of Micronized Zinc Oxide

250

(2)

Typical Specifications of Micronized Zinc Oxide

252

(1)

Surface Treatment

252

(4)

Background

252

(1)

Surface Properties of Micronized Pigments

253

(1)

Inorganic/Organic Surface Treatments

254

(1)

Popular Surface Treatments for Micronized Pigments

255

(1)

Surface Treatments of Micronized Titanium Dioxide or Zinc Oxide for Use with Avobenzone

255

(1)

Hydrophilic Surface Treatments for Micronized Pigments

255

(1)

Selecting the Proper Surface Treatment

255

(1)

Influence of Particle Size on UV Attenuation by TiO2 and ZnO

256

(8)

Particle Size

256

(1)

Influence of Particle Size on UV Attenuation

257

(1)

Titanium Dioxide

257

(2)

Zinc Oxide

259

(2)

Characterization of TiO2 and ZnO Dispersions

261

(3)

Dispersion of Inorganic Ultraviolet Filters

264

(3)

Objectives of the Dispersion Process

264

(1)

Index of Agglomeration

265

(1)

Advantages of Dispersions

266

(1)

Incorporating Micronized Pigments and Dispersions into Formulations

266

(1)

Producers of Dispersions

266

(1)

Formulations

267

(8)

Guidelines

267

(2)

Emulsifiers and Additives

269

(1)

Determining Suitable Levels of Actives

269

(1)

Foundations and Daily UV Lotions

270

(1)

Formulating with Zinc Oxide

270

(1)

Obtaining Broad-Spectrum Protection

271

(1)

Sample Formulations

272

(1)

W/O Waterproof Sunscreen Formula SPF 30+

272

(1)

O/W Sunscreen Lotion SPF 27

272

(1)

Sunscreen Cream Gel

273

(1)

Sprayable O/W Sunscreen SPF 15+

274

(1)

Regulations, Claims, Toxicity, and Testing

275

(1)

Summary

276

(1)

References

276

(5)

Inorganic Particulate Ultraviolet Filters in Commerce

281

(10)

Nadim A. Shaath

Ismail I. Walele

Introduction

282

(1)

Inorganic Particulates: Background

282

(1)

Formulating with Zinc Oxide and Titanium Dioxide

283

(1)

Inorganic Particulate Suppliers in the USA

284

(2)

US Consumer Products with Inorganic Particulates

286

(3)

Children/Baby Product

286

(1)

Formulations with Combination of Organic/Inorganic UV Filters

286

(1)

Formulations with Inorganic Particulates ``Only''

287

(1)

Daily Wear Long-Term Protective Products

287

(1)

Formulations with Combination of Organic/Inorganic UV Filters

287

(1)

Formulations with Inorganic Particulates ``Only''

288

(1)

Recreational Products

288

(1)

Formulations with Combination of Organic/Inorganic UV Filters

289

(1)

Inorganic Particulates ``Only'' Products

289

(1)

Conclusions

289

(1)

References

290

(1)

New Sunscreen Actives

291

(30)

Bernd Herzog

Dietmar Hueglin

Uli Osterwalder

Introduction

292

(3)

Trends in the Sunscreen Market

292

(1)

Objectives---Requirements

293

(1)

Efficacy

293

(1)

Safety

293

(1)

Registration

294

(1)

Patent Freedom

294

(1)

New Trends in the Development of UV Absorbers for Sunscreens

295

(7)

New Developments with Respect to Conventional UV Absorbers

296

(1)

New Product Forms

296

(1)

Case Study 1: Dispersions of Particulate Organic UV Absorbers

297

(1)

Photostability of MBBT

297

(3)

Synthesis of New Molecules

300

(1)

Case Study 2: BEMT---A New Filter Designed for Application in Sunscreens

300

(2)

Overview of New Sunscreen Actives

302

(10)

The Most Important Properties of UV Absorbers for Sunscreens

302

(1)

UV-Spectroscopic Performance

302

(1)

Solubility

302

(1)

Photostability

303

(1)

Discussion of the New UV Filters for Sunscreens

303

(1)

UV-B Filters

303

(3)

UV-A Filters

306

(3)

UV Broad-Spectrum Filters

309

(3)

Improved UV-A Protection with New UV-A and Broad-Spectrum UV Absorbers

312

(3)

Safety of the New UV Absorbers

315

(2)

Conclusions

317

(1)

References

317

(4)

The Photostability of Organic Sunscreen Actives: A Review

321

(32)

Craig A. Bonda

Introduction

322

(1)

Photostability as a Sunscreen Industry Concern

323

(1)

Photochemistry Review

323

(5)

Background

323

(1)

The Nature of Photon Absorption

324

(1)

Photochemical Reactions

324

(1)

Energy Transfer

325

(2)

Solvent Polarity and Electron Transfer Theory

327

(1)

Photostability of Individual Sunscreen Active Ingredients

328

(11)

Avobenzone (Butyl Methoxydibenzoylmethane)

329

(5)

Octinoxate (Octyl Methoxycinnamate)

334

(1)

Other UV Filters

335

(3)

UV Filter Combinations

338

(1)

Photostability of Sunscreen Formulations

339

(2)

Photostabilization Strategies

341

(4)

Formulation Strategies

341

(3)

Molecular Strategies

344

(1)

Conclusions

345

(1)

Acknowledgments

346

(1)

References

346

(7)

Cosmetic Formulations

Formulating Sunscreen Products

353

(32)

Kenneth Klein

Irwin Palefsky

Introduction

354

(2)

Formula Types

356

(6)

Emulsions

356

(2)

Oils

358

(1)

Gels

359

(2)

Sticks

361

(1)

Mousses

361

(1)

Aerosols

362

(1)

Ointments

362

(1)

Formulating Basics

362

(11)

Principles of Emulsification

362

(3)

Selecting Key Ingredients

365

(1)

Emulsifiers

365

(2)

Emollients

367

(1)

Film Formers

368

(1)

Stabilizers/Protectants

369

(1)

Organic Sunscreens

370

(2)

Inorganic/Particulate Sunscreens

372

(1)

Fragrances

373

(1)

Achieving Formula Goals

373

(3)

To Achieve High SPFs

373

(1)

To Achieve Water Resistance

374

(1)

To Obtain Mild Formulations

374

(1)

Patent Issues

375

(1)

Stability Evaluation

375

(1)

Organoleptic Considerations

376

(1)

The Use of Antioxidants in Sunscreen Formulations

376

(1)

Formulations

376

(6)

References

382

(3)

SPF Modulation: Optimizing the Efficacy of Sunscreens

385

(28)

Julian P. Hewitt

Outline

386

(1)

Introduction

386

(1)

Fundamental Requirements

387

(4)

Rheology

388

(1)

Emulsion Rheology

389

(2)

De-Emulsification Behavior

391

(1)

Formulating with Organic Sunscreens

391

(3)

Oil-Soluble Organic UV Filters

392

(1)

Effect of Emulsion Type

392

(1)

Effect of Added Emollients

393

(1)

Water-Soluble Organic UV Filters

394

(1)

Effect of Emulsion Type

394

(1)

Effect of Emulsifiers

394

(1)

Formulating with Inorganic Sunscreens

394

(10)

Basic Principles

394

(7)

Formulating with Water-Dispersed TiO2

401

(2)

Formulating with Oil-Dispersed TiO2

403

(1)

Formulating with Zinc Oxide

404

(1)

Combining Sunscreens

404

(2)

Combining Organic Sunscreens

405

(1)

Combining Inorganic Sunscreens

406

(1)

Combining Organic and Inorganic Sunscreens

406

(1)

SPF Modulation by External Factors: Water Resistance

406

(3)

Fundamental Requirements for Water Resistance

407

(1)

Strategies for Water Resistance

408

(1)

W/O Emulsions

408

(1)

Silicones

408

(1)

Specialized Emulsifiers

408

(1)

Liquid Crystal Gel Networks

409

(1)

Film-Forming Polymers

409

(1)

The ``Dual-Strategy'' Approach

409

(1)

Summary

409

(1)

References

410

(3)

The Role of Surfactants in Sunscreen Formulations

413

(36)

Gerd Dahms

The Role of Emulsifiers in General

414

(1)

Film Formation

415

(7)

O/W Sunscreen Formulations

422

(11)

Quick-Breaking O/W Sunscreen Emulsions

433

(4)

Sprayable O/W Emulsions

437

(3)

W/O Emulsions

440

(6)

Autoxidation of Emulsifiers

446

(2)

References

448

(1)

Role of Emollients and Emulsifiers in Sunscreen Formulations

449

(12)

Stefan Bruening

Mark Leonard

Rolf Kawa

Ulrich Issberner

Andrea Tomlinson

Introduction

450

(1)

What Are the Functions of Cosmetic Emollients in Sunscreen Emulsions?

450

(5)

Solvent Properties

450

(1)

Pigment-Dispersing Properties

451

(2)

Increased UV Absorption

453

(1)

Spreading Properties

454

(1)

What Are the Functions of Emulsifiers in Sunscreen Emulsions?

455

(2)

O/W Emulsifiers

456

(1)

W/O Emulsifiers

457

(1)

Technology for New Sunscreen Applications: Phase Inversion Temperature Emulsions

457

(2)

Conclusions

459

(1)

Acknowledgments

460

(1)

References

460

(1)

Surfactant-Free Sun Care

461

(32)

James M. Wilmott

Introduction

462

(1)

Background

462

(6)

Issues with the Current Sunscreen Products

462

(3)

Issues with Emulsions

465

(3)

Use of Surfactant-Free Dispersions in Sun Care

468

(7)

Properties of Lamellar Phase Dispersions

469

(5)

Lα Dispersions of Ultraviolet Absorbers

474

(1)

Dispersions of Organic UV Absorbers

474

(1)

Physical Sunscreen Suspensions

475

(1)

Formulating with Dispersions

475

(5)

Defining a Semiquantitiative Aesthetic Scale

475

(4)

Preparing the Final Formulation

479

(1)

The Advantages of Surfactant-Free Sunscreens

480

(5)

Beyond Conventional Sunscreens

485

(3)

Conclusion

488

(1)

References

488

(1)

Appendix 1

489

(4)

Sunscreen Formulations

489

(4)

Fragrancing of Sun Care Products

493

(14)

Felix Buccellato

Suntan Lotions, Creams, and Sprays

495

(6)

Fragrancing Sunscreens

501

(1)

Fragrance Safety and Photosensitization

502

(1)

Stability of Fragrances in Sunscreen Products

502

(1)

Color Stability: Ensulazole (INCI Name Phenylbenzimidazole Sulfonic Acid)

503

(1)

Reactive Acid and Amine Groups

503

(1)

Odor Stability

504

(1)

Future Developments

504

(2)

Fragrance Appropriateness

505

(1)

References

506

(1)

Formulating Natural Sun Care Products

507

(18)

Timothy Kapsner

Peter Matravers

Ko-ichi Shiozawa

Patricia Peterson

Introduction

508

(1)

Formulation Focus

508

(1)

UV Absorbing Ingredients

509

(2)

Increasing SPF

511

(1)

Natural Fragrances

512

(4)

Natural Standards

513

(1)

Points of Difference

514

(1)

Environmental Concern and Aromatherapy

514

(1)

The Environmental Principle

514

(1)

Aromatherapeutic Principle

514

(1)

Natural Aromas as they Relate to Sun Care Products

515

(1)

Preservatives

516

(2)

Next-Generation Sun Care

518

(1)

Biological Effects Due to Sun Exposure

518

(1)

Conclusions

519

(1)

References

520

(5)

Consumer Products with Ultraviolet Filters

Recreational Sunscreens

525

(10)

James P. SaNogueira

Introduction

525

(1)

Sunscreen History

526

(1)

Market Share and Trends

526

(1)

Formulations

527

(1)

Consumer Benefits and Performance Needs

527

(1)

Usage and Performance Needs During UV Exposure

528

(1)

Water/Sweat Resistance

529

(2)

Sunbathing/Suntanning Products

531

(1)

Fast Drying Sunscreen Gel

532

(1)

Additional Considerations

532

(1)

Patents

532

(1)

Photostability

533

(1)

Conclusions

533

(1)

References

533

(2)

Daily Use Sunscreens

535

(6)

Peter J. Lentini

Introduction

535

(1)

Biology

536

(1)

Engineering

536

(1)

Marketing

537

(1)

History

538

(1)

Current Market

539

(1)

Conclusions

540

(1)

References

540

(1)

Valuable Properties for Baby and Kids Segments

541

(16)

Dennis L. Lott

Kelly Lewellen

Glenn Wiener

Introduction

542

(1)

Review of Baby Segment

543

(1)

Review of Kids Segment

544

(1)

Sunscreen Actives

545

(2)

Titanium Dioxide

545

(1)

Zinc Oxide

546

(1)

Octinoxate

546

(1)

Homosalate

546

(1)

Octisalate

546

(1)

Oxybenzone

546

(1)

Octocrylene

546

(1)

Avobenzone

546

(1)

Baby Product Specific Strategies

547

(4)

Selection of Sunscreens/Carrier System

547

(1)

Sunscreen Optimization

548

(1)

Barrier Function Protection

549

(2)

Kids Product Specific Strategies

551

(1)

Formulation Types

552

(2)

Emulsions

552

(1)

Sticks

553

(1)

Lip Balms

553

(1)

Alcohol Sprays

553

(1)

Testing

554

(1)

SPF and Water Resistance

554

(1)

Migration

554

(1)

Hypoallergenicity

554

(1)

Moisturization

555

(1)

Photostability

555

(1)

Conclusions

555

(1)

References

555

(2)

Fabrics as UV Radiation Filters

557

(16)

Kathryn L. Hatch

Introduction

558

(1)

Fiber Distribution

558

(1)

Fiber Composition

559

(3)

Fiber Class Differences

559

(1)

Differences Within Natural Fiber Class

560

(1)

Differences Within Manufactured Fiber Class

561

(1)

Fabric Thickness

562

(1)

Dye Composition and Concentration

562

(2)

Comparison of Dyed Fabrics

562

(2)

Comparison of Dyes in Solution

564

(1)

UV-Absorbent Compounds

564

(6)

Optical Whitening (Brightening) Agents

564

(1)

Mill Applied

565

(1)

Detergent Ingredient Applied

565

(1)

Rinse-Cycle Fabric Softener Ingredient Applied

566

(1)

UV-Cutting Agents

566

(1)

Mill Applied

567

(1)

Detergent Ingredient Applied

568

(1)

Rinse-Cycle Fabric Softener Product Applied

569

(1)

Rinse Water Applied

570

(1)

Conclusion

570

(1)

References

571

(2)

Sunless Tanning and Tanning Accelerators

573

(30)

Anthony D. Gonzalez

Robert E. Kalafsky

Introduction

574

(1)

Tanning Products: Sunless Tanning V. Tanning Accelerators, a Market Review

574

(2)

Biological Tanning

576

(5)

The UV Radiation Response

576

(2)

Melanogenesis

578

(1)

Regulatory Considerations

579

(1)

Enhancing Biological Tanning

580

(1)

Artificial Tanning

581

(7)

Regulatory Considerations

582

(1)

Dihydroxyacetone

583

(3)

Formulating with DHA

586

(1)

Quality Control

586

(1)

Formulation

586

(2)

Top 10 Products Review (Ranked by 2002 Sales)

588

(6)

Tanning Accelerators

588

(3)

Sunless Tanners

591

(3)

Conclusion

594

(1)

References

595

(8)

Other Actives in the Sun Care Industry

Role of Antioxidants in Sun Care Products

603

(36)

Ratan K. Chaudhuri

Introduction

604

(1)

UV-Induced Chemical and Biochemical Changes: Causes and Consequences

605

(4)

Photosensitizer and Reactive Oxygen Species

605

(1)

Iron and Copper

605

(2)

Matrix-Degrading Metalloprotease

607

(2)

Antioxidant Defenses of the Skin

609

(2)

Antioxidant Defense Enzymes

609

(1)

Low Molecular Weight Antioxidants

610

(1)

Photoprotection of Human Skin Using Antioxidants and Other Photoprotectants

611

(9)

Vitamin E and Its Derivatives

612

(2)

Vitamin C and Its Derivatives

614

(1)

Carotenoids

615

(2)

Plant Polyphenolics

617

(1)

Tea Polyphenols

618

(1)

Silymarin

618

(1)

Emblica Antioxidant

619

(1)

Combination of Antioxidants

620

(1)

Unconventional Photoprotectants

621

(3)

Selenium

622

(1)

Zinc

622

(1)

Chelating Agents

622

(1)

Compatible Solutes

623

(1)

Retinoids

623

(1)

Dihydroxyacetone

624

(1)

Commercial Products

624

(1)

Conclusions

624

(5)

References

629

(10)

Photoprotection by Green Tea Polyphenols

639

(18)

Craig A. Elmets

Santosh K. Katiyar

Nabiha Yusuf

Introduction

640

(1)

Green Tea Polyphenols and Photoprotection

641

(1)

Photoprotective Effects of Green Tea Polyphenols in Skin Cancer

642

(1)

Green Tea Polyphenols and the Different Stages of Photocarcinogenesis

643

(1)

Photoprotective Effects of Green Tea Polyphenols on the Acute UV-Induced Sunburn Response

644

(1)

Photoprotective Effects of Green Tea Polyphenols on Photoaging

645

(1)

Protective Effects of Green Tea Polyphenols in UV-Induced Immunosuppression

646

(1)

Mechanisms of Action of Green Tea Polyphenols

647

(3)

Cellular Effects

647

(1)

Apoptosis

647

(1)

Proliferation of Keratinocytes

647

(1)

Inflammatory Cell Infiltration

647

(1)

Molecular Effects

648

(1)

DNA Damage

648

(1)

Reactive Oxygen Intermediates

648

(1)

Proteasome Activation

649

(1)

Biochemical Activities

649

(1)

Conclusions

650

(1)

Acknowledgments

651

(1)

References

651

(6)

Botanicals in Sun Care Products

657

(16)

Howard Epstein

Introduction

657

(2)

Botanicals of Specific Interest

659

(2)

Botanically Derived Sunscreens and SPF Boosters

659

(1)

Botanicals as Photochemoprotective Agents

660

(1)

Botanicals in Sun Care Products

661

(1)

Quality Control: Methods of Analysis

661

(8)

Recent Research Techniques: Biological Assays and Cell Culture

665

(1)

Biological Assays of Interest for Screening Botanicals in Sun Care Products

666

(3)

Conclusion

669

(1)

References

669

(4)

Antiaging Actives in Sunscreens

673

(26)

Karl Lintner

Introduction

673

(4)

Strategies of Antiaging Actives in Sunscreens

677

(12)

Prevention of Damage (``Slowing Down the Aging Process'')

677

(1)

Vitamins

677

(3)

Botanicals

680

(1)

Enzymes

681

(2)

Miscellaneous

683

(1)

Treatment of UV-Induced Age Symptoms

684

(1)

Barrier Repair

685

(1)

Tissue Repair

686

(3)

Conclusions

689

(1)

References

689

(10)

Production and Quality Control

The Manufacture of Suncare Products

699

(20)

Timothy Meadows

Introduction

700

(1)

Product Types

700

(7)

Oil-in-Water Emulsions

700

(3)

Water-in-Oil Emulsions

703

(1)

Spray Emulsions

703

(2)

Heavy Creams

705

(1)

Hydroalcoholic Products

705

(2)

Scale Up

707

(1)

Mass

707

(1)

Mixing

707

(1)

Cooling

707

(1)

Production Methods

708

(1)

Raw Material Handling

709

(1)

Quality Control of Sunscreens

710

(6)

Stability Testing

712

(1)

Analysis by Nonscanning UV Analysis

713

(3)

Contract Manufacturing of Suncare Products

716

(2)

Conclusions

718

(1)

References

718

(1)

Quality Control of Finished Sunscreen Products

719

(16)

Henry T. Kalinoski

Introduction

719

(2)

Product Forms

721

(1)

Sampling

721

(1)

Physical Methods

722

(3)

Chemical Methods

725

(1)

Spectroscopy

726

(1)

Chromatography

727

(1)

Validation

728

(1)

Microbiology

729

(1)

Efficacy

730

(1)

Stability

730

(1)

Summary

730

(1)

References

731

(4)

Quality Control of Ultraviolet Filters

735

(16)

Nadim A. Shaath

Introduction

736

(1)

FDA Approved Category I UV Filters

736

(1)

Quality Control Procedures

737

(11)

Physical Analyses

737

(1)

Odor

737

(1)

Color

737

(1)

Physical Appearance

738

(1)

Melting Point

738

(1)

Refractive Index

738

(1)

Specific Gravity

738

(1)

Optical Rotation

738

(1)

Solubility

739

(1)

Moisture Determination

739

(1)

Viscosity

739

(1)

pH Determination

739

(1)

Flash Point

739

(1)

Chemical Analyses

739

(1)

Saponification Value

739

(1)

Acid Value

740

(1)

Functional Group Analysis

740

(1)

Metal Contents

740

(1)

Chromatographic Techniques

740

(1)

Gas Chromatography

740

(1)

High-Performance Liquid Chromatography

741

(1)

Spectroscopic Techniques

742

(1)

Ultraviolet Spectroscopy

742

(2)

Nuclear Magnetic Resonance Spectroscopy

744

(1)

Infrared Spectroscopy

745

(1)

Mass Spectrometry

746

(1)

Atomic Absorption and Emission Spectroscopy

747

(1)

Inductively Coupled Plasma

747

(1)

Conclusions

748

(1)

References

748

(3)

Modern Analytical Techniques in the Sunscreen Industry

751

(18)

Nadim A. Shaath

Frederick Flores

Introduction

752

(1)

Separation Techniques

753

(2)

Physicochemical Methods

753

(1)

Extractions

753

(1)

Distillations

754

(1)

Sublimations

754

(1)

Chromatographic Methods

754

(1)

Gas Chromatography

754

(1)

High-Performance Liquid Chromatography

755

(1)

Headspace (Purge and Trap)

755

(1)

Ion Chromatography

755

(1)

Identification Techniques

755

(3)

Chemical Methods

755

(1)

Chromatographic Methods

756

(1)

Gas Chromatography/Retention Time

756

(1)

Gas Chromatography/Mass Spectrometry/Data System

756

(1)

High-Performance Liquid Chromatography/Retention Time

756

(1)

Headspace/Gas Chromatography/Retention Time

756

(1)

Spectroscopic Methods

756

(1)

Mass Spectrometry

756

(1)

Infrared Spectroscopy

757

(1)

Ultraviolet Spectroscopy

757

(1)

Nuclear Magnetic Resonance Spectroscopy

757

(1)

In Vitro Sun Protection Factor Analyzers

758

(1)

New Analytical Techniques

758

(6)

GC and GC/MS Ancillary Methods

760

(1)

Fast GC

760

(1)

GC Racer

760

(1)

Retention Time Locking

760

(1)

Programmable Temperature Vaporizing Inlet

761

(1)

Simplified 2-D GC

761

(1)

Solid Phase Microextraction

761

(1)

Gerstel Twister and Thermodesorption

762

(1)

Mass Spectrometer---Selective Ion Monitoring

762

(1)

Atomic Emission Detector

762

(1)

HPLC Ancillary Methods

763

(1)

Fast HPLC

763

(1)

Liquid Chromatography/Mass Spectrometry

763

(1)

Other Methods

763

(1)

Supercritical Fluid Extraction

763

(1)

Inductively Coupled Plasma

763

(1)

X-Ray Photoelectron Spectroscopy

764

(1)

X-Ray Fluorescence Spectroscopy (Auger Electron)

764

(1)

Conclusions

764

(1)

References

765

(4)

Analytical Testing Procedures

US FDA Protocol for Determining Sun Protection Factor

769

(10)

Toni F. Miller

Background of FDA Sunscreen Guidelines

770

(1)

Sun Protection Factor Determination (64 FR 27666)

770

(5)

Light Source: Solar Simulators

770

(1)

Standard Sunscreen

770

(1)

Testing Procedure

771

(1)

Selection of Panel Subjects

771

(1)

Informed Consent

771

(1)

Skin Test Sites

771

(1)

Application of Test Materials

772

(1)

Evaluation of Response

772

(1)

Determination of the MED for Unprotected Skin

772

(1)

Rejection of Test Data

772

(1)

Determination of the SPF Value

773

(1)

Determination of Individual Subject SPF Values

773

(1)

Determination of the Test Product's SPF Value and Product Category Designation

773

(1)

Determination of a Water Resistant or Very Water Resistant Product

774

(1)

Test Modifications

775

(1)

US vs. the International SPF Testing Method

775

(3)

References

778

(1)

SPF Testing in Europe

779

(28)

Mike Brown

Introduction

779

(3)

The International SPF Test Method

782

(16)

The UV Light Source

784

(6)

Volunteer Selection

790

(1)

Product Application Procedure

791

(1)

Use of Standard Products

792

(1)

UV Exposure Procedure

793

(1)

Minimum Erythemal Dose Definition and Determination

794

(1)

SPF Calculation and Statistical Acceptance/Rejection Criteria

795

(3)

Comparison of the International SPF Test Method and the US FDA SPF Method

798

(1)

SPF Labeling Guidelines

798

(5)

Water Resistance Testing and UV-A Measurement

803

(2)

Acknowledgments

805

(1)

References

805

(2)

Balancing UV-A and UV-B Protection in Sunscreen Products: Proportionality, Quantitative Measurement of Efficacy, and Clear Communication to Consumers

807

(20)

Patricia P. Agin

Curtis A. Cole

Christopher Corbett

Cheryl M. Sanzare

Kenneth Marenus

John P. Tedeschi

Carolyn B. Wills

Introduction

808

(1)

Background on the Requirements for UV-A/UV-B Proportionality

809

(6)

Protection Minimums for Proportional UV-A/UV-B Protection

811

(2)

Beyond the Minimum Balance Requirements: Extra UV-A Protection

813

(1)

Identification and Communication of Two Distinct Levels of UV-A Protection

813

(2)

The Need to Measure Both Breadth and Quantity of Protection

815

(1)

Testing Formulations to Evaluate the Reproducibility of the PFA and Persistent Pigment Darkening UV-A Test Methods, with Additional Assessment of Broadness

816

(1)

Results

817

(1)

Discussion

818

(5)

Conclusions and Recommendations

823

(1)

References

824

(3)

Dosimetry of Ultraviolet Radiation: An Update

827

(16)

B. L. Diffey

Nature of Ultraviolet Radiation

828

(1)

Quantities and Units

829

(1)

Radiometric Calculations

829

(1)

The Standard Erythema Dose

830

(1)

Detection of UV Radiation

830

(1)

Dosimetry of UV Radiation

831

(1)

Spectroradiometry

831

(3)

Components of a Spectroradiometer

832

(1)

Input Optics

832

(1)

Monochromator

832

(1)

Detector

833

(1)

Calibration

833

(1)

Sources of Error in Spectroradiometry

833

(1)

Commercial Spectroradiometers

833

(1)

Broad-Band Radiometry

834

(1)

Spectral Sensitivity

834

(1)

Angular Response

834

(1)

Radiometers That Simulate Biological Action Spectra

835

(1)

Wavelength-Independent Radiometry

835

(1)

Radiometer Stability

835

(1)

Measuring Personal Exposure to UV Radiation

836

(1)

Physical Dosimeters

836

(1)

Chemical Dosimeters

836

(1)

Biological Dosimeters

836

(1)

Simulated Sources of Sunlight

837

(3)

Xenon Arc Lamps

837

(1)

Fluorescent Lamps

837

(3)

References

840

(3)

Spectral Standardization of Sources Used for Sunscreen Testing: 5 Years of Compliance

843

(10)

Robert M. Sayre

John C. Dowdy

Introduction

843

(2)

Methods

845

(1)

Instrumentation

845

(1)

Calibration Procedures

845

(1)

Measurement Procedures

845

(1)

Measurement Uncertainty

846

(1)

Results

846

(2)

Discussion

848

(2)

Conclusion

850

(1)

References

851

(2)

In Vitro Techniques in Sunscreen Development

853

(28)

Joseph W. Stanfield

Introduction

854

(1)

Basic Principles of In Vitro Measurements of Sunscreen Protection

854

(2)

Experience with In Vitro Measurements of Sunscreen Protection

856

(17)

Early In Vitro Measurements of Sunscreen SPF

856

(2)

The O'Neill Step Film Model

858

(2)

SPF Predictions Using the Step Film Model

860

(1)

Substrates for In Vitro Measurements of Sunscreen Protection

860

(1)

Critical Wavelength

861

(1)

Simultaneous In Vitro Measurement of SPF and Photostability

862

(3)

UV-A Index

865

(1)

Ring Test of In Vitro SPF, PPDPF, and UV-A Index Measurements

866

(3)

European Ring Test of In Vitro SPF Measurements

869

(4)

Discussion

873

(4)

Product SPF Values

873

(1)

Product Application and Substrate Considerations

873

(2)

UV Source

875

(1)

Beam Geometry

876

(1)

Photostability

876

(1)

Applications of Sunscreen Transmittance Spectra

877

(1)

Conclusions

877

(1)

References

877

(4)

Prediction of Sun Protection Factors and UV-A Parameters by Calculation of UV Transmissions Through Sunscreen Films of Inhomogenous Surface Structure

881

(22)

Bernd Herzog

Introduction

882

(1)

Materials and Methods

883

(2)

UV Filters and Formulations

883

(1)

Measurement of UV Spectra

884

(1)

Measurement of UV-A Parameters

885

(1)

Introduction of Step Film Inhomogeneity by Mathematical Models

885

(6)

Calculation of Average UV Spectra from the Spectra of Individual UV Filters

885

(1)

The Step Film Model by O'Neill

886

(3)

Using a Distribution Function for Introduction of Film Inhomogeneity

889

(2)

Correlation of Experimental and Calculated Data

891

(8)

Calculated SPF and SPF In Vivo

891

(4)

Correlation of Calculated UV-A Parameters and UV-A Parameters Measured In Vitro

895

(4)

Summary

899

(1)

References

899

(4)

Marketing and Information

Single Sunscreen Application Can Provide Day-Long Protection

903

(10)

Robert M. Sayre

John C. Dowdy

William Shields

Introduction

903

(1)

Methods

904

(5)

Protocol

904

(1)

Sunlight Exposure Dosimetery

904

(3)

Statistical Methods

907

(2)

Results

909

(1)

Discussion

910

(1)

Acknowledgment

911

(1)

References

911

(2)

The Role of Publications in the Industry

913

(6)

Nancy Allured

Trade Publications

914

(1)

Scientific Journals

915

(1)

Technical Books

915

(1)

Electronic Information

915

(1)

More Resources

916

(1)

Appendix---Industry Publications

916

(3)

Trade Publications

916

(1)

Scientific Publications

917

(1)

Electronic Information

917

(1)

Consumer Press

917

(1)

Regulatory Resources

918

(1)

Technical Information in the Expanding Sunscreen Field

919

(10)

Regina Lim

Christopher D. Vaughan

Edwin D. Leonard, Jr.

Introduction

920

(1)

Technical Conferences

921

(1)

The Florida Sunscreen Symposium

921

(1)

The European UV Sunfilters Conference and Exhibition

921

(1)

The Sun Protection Conference

922

(1)

Educational Courses

922

(1)

Scientific Societies

923

(1)

The American Society for Photobiology (ASP)

923

(1)

The Society of Cosmetic Chemists (SCC)

923

(1)

The American Academy of Dermatology (AAD)

923

(1)

Scientific Journals

923

(2)

Scientific Books

925

(1)

Internet Websites

925

(2)

Conclusions

927

(1)

References

927

(2)

Recent Sunscreen Market Trends

929

(12)

Nadim A. Shaath

Mona Shaath

Introduction

929

(2)

Classification of the Sunscreen Market

931

(6)

Daily Wear and Long-Term Protective Products

931

(1)

Premium and Specialty Brands

932

(1)

Mass Market Brands

933

(1)

Direct Sales Brands

933

(1)

Tanning Products

934

(1)

Recreational Products

935

(2)

Future Trends

937

(3)

New Regulations

937

(1)

Advances in Technology

938

(2)

Conclusions

940

(1)

References

940

(1)

Index

941

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