Author Biography xxiii

Preface xxv

Acknowledgments xxvii

About the Companion Website xxix

Part 1 General Concepts 1

1 Basic Definitions. Claims. Classification of Cosmetics and OTC Drug-Cosmetic Products 3

Learning Objectives 3

Key Concepts 4

1.1 What Is Cosmetic Science? 5

1.2 Basic Definitions 8

1.2.1 United States 8

1.2.2 Other Markets 10

1.3 How is a Product's Intended Use Established in the US? 13

1.4 Classification of Cosmetics and OTC Drug-Cosmetic Products 14

1.5 Cosmetic Claims 15

1.5.1 Types of Claims 15

1.5.2 Regulation of Cosmetic Claims in the US 17

1.5.3 Popular Cosmetic Claims 18

1.6 A Special Category: Soap 27

Glossary of Terms 28

Abbreviations 30

References 30

2 Cosmetic Ingredients and Active Ingredients Used in OTC Drug-Cosmetic Products 33

Learning Objectives 33

Key Concepts 34

2.1 Cosmetic Ingredients 35

2.1.1 Abrasives 35

2.1.2 Antioxidants 36

2.1.3 Chelating Agents 37

2.1.4 Color Additives 38

2.1.5 Exfoliants 41

2.1.6 Film Formers 42

2.1.7 Flavoring Agents 42

2.1.8 Fragrances 43

2.1.9 Moisturizers 45

2.1.10 pH Adjusters 46

2.1.11 pH Buffers 46

2.1.12 Plasticizers 46

2.1.13 Preservatives 47

2.1.14 Propellants 48

2.1.15 Silicones 48

2.1.16 Solvents 49

2.1.17 Surfactants 50

2.1.18 Sweeteners 53

2.1.19 Thickeners 53

2.2 Active Ingredients 55

2.2.1 Anti-Acne Ingredients 56

2.2.2 Anticavity Ingredients 57

2.2.3 Anti-Dandruff Ingredients 57

2.2.4 Antiperspirant Ingredients 57

2.2.5 Skin Protectant Ingredients 58

2.2.6 Topical Antiseptic Ingredients 58

2.2.7 UV Filters 59

Glossary of Terms 59

Abbreviations 61

References 62

3 Product forms for Cosmetics and OTC Drug-Cosmetic Products 65

Learning Objectives 65

Key Concepts 66

3.1 Introduction 66

3.2 What is a Product Form? 67

3.3 Product Forms for Cosmetic Applications 68

3.3.1 Solution 68

3.3.2 Emulsion 69

3.3.3 Suspension 72

3.3.4 Ointment 74

3.3.5 Paste 75

3.3.6 Gel 75

3.3.7 Powder 76

3.3.8 Capsule 77

3.3.9 Stick 77

3.3.10 Aerosol 77

Glossary of Terms 78

Abbreviations 79

References 80

4 Government and Independent Organizations in the Cosmetic Industry 81

Learning Objectives 81

Key Concepts 82

4.1 Introduction 83

4.2 Food and Drug Administration 83

4.2.1 FDA Center for Food Safety and Applied Nutrition (CFSAN) 84

4.2.2 FDA Center for Drug Evaluation and Research (CDER) 84

4.3 Personal Care Product Council 85

4.4 Cosmetic Ingredient Review Expert Panel 85

4.5 Federal Trade Commission 86

4.6 National Advertising Division 87

4.7 Environmental Protection Agency 87

4.8 International Fragrance Association (IFRA) 88

4.9 Research Institute for Fragrance Materials (RIFM) 88

4.10 Flavor and Extract Manufacturers Association (FEMA) 88

[...]opean Commission 89

4.12 Scientific Committee on Consumer Safety 89

4.13 Cosmetics Europe - the Personal Care Association 89

Glossary of Terms 90

Abbreviations 90

References 91

5 Current Rules and Regulations for Cosmetics and OTC Drug-Cosmetic Products in the United States and European Union 93

Learning Objectives 93

Key Concepts 94

5.1 Introduction 95

5.2 Regulation in the US 95

5.2.1 Registration of Manufacturing Facilities and Products 95

5.2.2 Premarket Approval 97

5.2.3 Manufacturing 98

5.2.4 Use of Ingredients 98

5.2.5 Product Safety 99

5.2.6 Packaging and Labeling 101

5.2.7 Import of Products 102

5.2.8 Recalls 102

5.3 Regulation in the EU 104

5.3.1 Registration of Manufacturing Facilities and Products 105

5.3.2 Premarket Approval 105

5.3.3 Manufacturing 105

5.3.4 Use of Ingredients 105

5.3.5 Product Safety 106

5.3.6 Packaging and Labeling 107

5.3.7 Import of Products 107

5.3.8 Recalls 107

Glossary of Terms 108

Abbreviations 108

References 109

6 Cosmetic Good Manufacturing Practices 111

Learning Objectives 111

Key Concepts 112

6.1 Cosmetic Good Manufacturing Practices 112

6.1.1 Documentation 115

6.1.2 Records 115

6.1.3 Buildings and Facilities 116

6.1.4 Equipment 116

6.1.5 Personnel 116

6.1.6 Raw Materials 117

6.1.7 Production 117

6.1.8 Laboratory Controls 117

6.1.9 Internal Audit 117

6.1.10 Complaints Adverse Events and Recalls 117

Glossary of Terms 119

Abbreviations 120

References 120

7 Labeling Tutorial for Cosmetics and OTC Drug-Cosmetic Products Marketed in the United States. INCI Names 121

Learning Objectives 121

Key Concepts 122

7.1 Introduction 123

7.1.1 Definitions 124

7.2 Cosmetic Products 125

7.2.1 Principal Display Panel 125

7.2.2 Information Panels 127

7.3 OTC Drug-Cosmetic Products 130

7.3.1 Principal Display Panel 130

7.3.2 Information Panels 131

7.4 INCI Naming 134

7.5 Do You Know the Exact Composition of a Cosmetic Product or OTC Drug-Cosmetic Product? 136

Glossary of Terms 137

Abbreviations 138

References 139

8 Testing of Cosmetics and OTC Drug-Cosmetic Products 141

Learning Objectives 141

Key Concepts 142

8.1 Product Development Cycle 143

8.2 Product Testing 144

8.2.1 Quality Testing 145

8.2.2 Stability Testing 147

8.2.3 Safety Testing 150

8.2.4 Performance Testing 153

Glossary of Terms 156

Abbreviations 157

References 157

Part 2 Skin Care Products 161

9 Skin Anatomy and Physiology 163

Learning Objectives 163

Key Concepts 164

9.1 Introduction 165

9.2 Structure and Function of Human Skin 165

9.2.1 Epidermis 165

9.2.2 Dermis 170

9.2.3 Hypodermis 172

9.3 Main Characteristics of Human Skin 172

9.3.1 Moisture Content of Normal Skin 172

9.3.2 Skin Flora and Skin pH 174

9.3.3 Surface Charge of Normal Skin 175

9.3.4 Skin Types 175

Glossary of Terms 178

Abbreviations 180

References 180

10 Skin Cleansing Products 183

Learning Objectives 183

Key Concepts 185

10.1 Introduction 186

10.2 Types and Definition of Skin Cleansing Products 186

10.3 History of Using Skin Cleansing Products 187

10.4 How Skin Cleansers May Affect the Skin 188

10.5 Required Characteristics and Consumer Needs 191

10.6 Basic Concepts of Skin Cleansing Products 191

10.6.1 Classification Based on Chemical Nature and Mildness 191

10.6.2 Classification Based on Cleaning Principle 192

10.6.3 Classification Based on Foamability 193

10.6.4 Classification Based on Product Types 194

10.7 Typical Ingredients and Formulation of Skin Cleansing Products 195

10.7.1 Facial Cleansers 195

10.7.2 Body Cleansers 200

10.7.3 Hand Cleansers 206

10.8 Considerations When Selecting Skin Cleansing Products 211

10.9 Typical Quality Problems of Skin Cleansing Products 212

10.9.1 Sticky Bath Salts and Bath Bombs 212

10.9.2 Broken Bath Bombs 213

10.9.3 Discoloration of Bar Soaps 213

10.9.4 Poor Foaming Activity of Foaming Formulations 213

10.9.5 Separation of Emulsions 213

10.9.6 Cloudy Solution 215

10.9.7 Microbiological Contamination 215

10.9.8 Clump formation 216

10.9.9 Rancidity 216

10.10 Evaluation of Skin Cleansing Products 216

10.10.1 Quality Parameters Generally Tested 216

10.10.2 Efficacy (Performance) Parameters Generally Tested 229

10.11 Ingredients Causing Safety Concerns 231

10.11.1 Parabens 231

10.11.2 Sulfates 232

10.11.3 1,4-Dioxane 232

10.11.4 Microbeads 233

10.12 Packaging of Skin Cleansing Products 233

Glossary of Terms 234

Abbreviations 236

References 237

11 Skin Moisturizing Products 243

Learning Objectives 243

Key Concepts 244

11.1 Introduction 245

11.2 Types and Definition of Skin Moisturizers 245

11.3 History of Using Skin Moisturizers 246

11.4 How Skin Moisturizers May Affect the Skin 247

11.5 Required Characteristics and Consumer Needs 249

11.6 Typical Ingredients and Formulation of Skin Moisturizers 249

11.6.1 Skin Hydrating and Moisturizing Ingredients 250

11.6.2 Additional Ingredients in Skin Moisturizers 254

11.7 Product Types 256

11.7.1 Formulation of Skin Moisturizers 258

11.8 Considerations When Selecting Skin Moisturizers 259

11.9 Typical Quality Issues of Skin Moisturizer Formulations 260

11.10 Evaluation of Skin Moisturizing Products 260

11.10.1 Quality Parameters Generally Tested 260

11.10.2 Efficacy (Performance) Parameters Generally Tested 260

11.11 Ingredients Causing Safety Concerns 267

11.12 Packing of Skin Moisturizers 268

Glossary of Terms 269

Acronyms 270

References 270

12 Products for Aging 275

Learning Objectives 275

Key Concepts 276

12.1 Introduction 277

12.2 Changes in Skin Structure and Function During Aging 277

12.2.1 Intrinsic Aging 277

12.2.2 Extrinsic Aging 279

12.3 Drug or Cosmetic? 281

12.4 Typical Ingredients Used in Topical Antiaging Products 282

12.4.1...