OTC Monograph M020: Sunscreen Drug Products for OTC Human Use

Law · OTC Monograph M020 · posted 24 Sep 2021 · checked 30 Sep 2026 · Official source: accessdata.fda.gov

Cover page of the original

page 1

U.S. Food and Drug Administration

Over-the-Counter Monograph M020:

Sunscreen Drug Products for Over-the-Counter Human Use

(Posted September 24, 2021)1

Sec.

M020.1 Scope

M020.10 Sunscreen active ingredients

M020.20 Permitted combinations of active ingredients

§ M020.50 Labeling of sunscreen drug products

§ M020.80 Sun Protection Factor (SPF) test procedure

§ M020.90 Broad spectrum test procedure

Part A—General Provisions

Part B—Active Ingredients

Part C—Labeling

Part D—Testing Procedures

  • § M020.80 Sun Protection Factor (SPF) test procedure · a laboratory test procedure with formulas; read it in FDA's original
  • § M020.90 Broad spectrum test procedure · a laboratory test procedure with formulas; read it in FDA's original