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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
Expert Translation AI Translation View Official Documents

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.

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