[Code of Federal Regulations] [Title 21 Volume 5] [Revised as of April 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR352.1] [Page 274] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 352--SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]--Table of Contents Subpart A--General Provisions Sec. 352.1 Scope. (a) An over-the-counter sunscreen drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in Sec. 330.1 of this chapter. (b) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21 unless otherwise noted.