Title 21

PART 352

Part 352 - Sunscreen Drug Products For Over-the-counter Human Use [stayed Indefinitely]

PART 352 - SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] 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 68 FR 33381, June 4, 2003, part 352 was stayed until further notice, effective June 4, 2004.

• Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
• Source: 64 FR 27687, May 21, 1999, unless otherwise noted.

21:5.0.1.1.27.1	SUBPART A	Subpart A - General Provisions
21:5.0.1.1.27.1.1.1	SECTION 352.1	352.1 Scope.
21:5.0.1.1.27.1.1.2	SECTION 352.3	352.3 Definitions.
21:5.0.1.1.27.2	SUBPART B	Subpart B - Active Ingredients
21:5.0.1.1.27.2.1.1	SECTION 352.10	352.10 Sunscreen active ingredients.
21:5.0.1.1.27.2.1.3	SECTION 352.20	352.20 Permitted combinations of active ingredients.
21:5.0.1.1.27.3	SUBPART C	Subpart C - Labeling
21:5.0.1.1.27.3.1.1	SECTION 352.50	352.50 Principal display panel of all sunscreen drug products.
21:5.0.1.1.27.3.1.2	SECTION 352.52	352.52 Labeling of sunscreen drug products.
21:5.0.1.1.27.3.1.3	SECTION 352.60	352.60 Labeling of permitted combinations of active ingredients.
21:5.0.1.1.27.4	SUBPART D	Subpart D - Testing Procedures
21:5.0.1.1.27.4.1.1	SECTION 352.70	352.70 Standard sunscreen.
21:5.0.1.1.27.4.1.2	SECTION 352.71	352.71 Light source (solar simulator).
21:5.0.1.1.27.4.1.3	SECTION 352.72	352.72 General testing procedures.
21:5.0.1.1.27.4.1.4	SECTION 352.73	352.73 Determination of SPF value.
21:5.0.1.1.27.4.1.5	SECTION 352.76	352.76 Determination if a product is water resistant or very water resistant.
21:5.0.1.1.27.4.1.6	SECTION 352.77	352.77 Test modifications.

---