chapter  12
16 Pages

Sunscreen Products: The Role of the US Pharmacopeia

Introduction 200

The US Pharmacopeia 201

Mission 201

History 201

Legal Recognition 201

United States Pharmacopeia and National Formulary 201

USP Reference Standards 203

Standards-Setting Body 203

Monograph Development and Revision Process 204

Overview 204

Contributors 204

Revision Process 205

Guideline for Submitting Revisions 205

Pharmacopeial Forum 207

USP Monographs for Sunscreen Active Ingredients 207

USP Monographs for Active Ingredients Identified in 21 CFR 352.10 208

USP Monographs for Ingredients not Identified in 21 CFR 352.10 209

Conclusion 210

Appendix 210

References 212


A major function of the United States Pharmacopeia (USP) is the development

of monographs containing public standards for articles such as prescription/ nonprescription drugs, dietary supplements, and excipients. These standards

help to ensure that the public receives quality medicines and supplements.