[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR352.1]

[Page 291]
 
                        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.




                      Subpart A_General Provisions

Sec.
352.1 Scope.
352.3 Definitions.

                      Subpart B_Active Ingredients

352.10 Sunscreen active ingredients.
352.20 Permitted combinations of active ingredients.

                           Subpart C_Labeling

352.50 Principal display panel of all sunscreen drug products.
352.52 Labeling of sunscreen drug products.
352.60 Labeling of permitted combinations of active ingredients.

                      Subpart D_Testing Procedures

352.70 Standard sunscreen.
352.71 Light source (solar simulator).
352.72 General testing procedures.
352.73 Determination of SPF value.
352.76 Determination if a product is water resistant or very water 
          resistant.
352.77 Test modifications.

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

    Source: 64 FR 27687, May 21, 1999, unless otherwise noted.

    Effective Date Note: At 64 FR 27687, May 21, 1999, part 352 was 
added, effective May 21, 2001. At 65 FR 36319, June 8, 2000, the 
effective date was delayed until Dec. 31, 2002. At 66 FR 67485, Dec. 31, 
2001, the effective date was stayed until further notice.

    Effective Date Note: At 68 FR 33380, June 4, 2003, the stay on part 
352 was lifted and amendments were made to Sec. Sec. 352.20, 352.52, 
and 352.60, effective June 4, 2004. At 68 FR 33381, June 4, 2003, part 
352 was again stayed until further notice, effective June 4, 2004.



    (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.