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Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use
Local Title:
Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use
Country/Region:
US
Competent Authority:
U.S. Food and Drug Administration (FDA)
Type:
Regulation
Status:
In force
Release Date:
2021-09-24
Implementation Date:
2021-09-24
Document
Language Source Title Access
EN
 Official Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use
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Summary

OTC Monograph M020 is the FDA's set of rules for over-the-counter sunscreens. It lists which active ingredients are allowed, how much can be used, what forms (lotions, sprays, etc.) are permitted, and what labeling is required. Sunscreens that follow these rules can be sold without individual FDA approval.

History
2026-06-10
Final Administrative Order (OTC000039): Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the Counter Human Use, and Related Information
In force
Release Date: 2026-06-10
Implementation Date : 2026-08-09
2021-09-24
Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use
In force
Release Date: 2021-09-24
Implementation Date : 2021-09-24
Noteworthy Information
User Guide