Final Administrative Order (OTC000039): Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the Counter Human Use, and Related Information

Local Title

Final Administrative Order (OTC000039) Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the Counter Human Use, and Related Information (Issued June 10, 2026)

Country/Region

Competent Authority

U.S. Food and Drug Administration (FDA)

Type

Notice

Status

In force

Release Date

2026-06-10

Implementation Date

2026-08-09

Expert Translation

AI Translation

View Official Documents

Summary

History

Noteworthy Information

On June 10, 2026, the U.S. Food and Drug Administration (FDA) issued Final Administrative Order OTC000039, officially amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use to add bemotrizinol as a permitted active ingredient.

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
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