NEWS & BLOGS

What’s Changing in U.S. Sunscreen (OTC) Regulations? Key Points of the FDA M020 Update

Provision Consulting Group
Dec 22, 2025
3 min read

In the United States, sunscreens are regulated as OTC (Over-the-Counter) drugs, not cosmetics. This means they are subject to strict regulatory frameworks governing everything from ingredients and SPF testing to labeling and safety standards.

Recent FDA announcements do not necessarily mean an immediate overhaul of all existing rules. Instead, they signal a strategic update to OTC Monograph M020, clarifying the standards and direction for future sunscreen regulations.

How is the FDA Reorganizing Sunscreen Regulations?

The FDA is currently transitioning the Sunscreen Monograph (M020) to align with GRASE standards.

What is GRASE? Generally Recognized As Safe and Effective. It refers to a status where a product can be legally marketed without an individual New Drug Application (NDA), provided it meets specific conditions.

This modernization effort goes beyond ingredients—it establishes a "standardized blueprint" for OTC sunscreens, covering concentrations, dosage forms, labeling, and testing requirements. Following the 2019 Proposed Rule and the CARES Act (Section 505G), the process has moved toward a more efficient Administrative Order system. A recent milestone (Dec 2025) includes the proposed addition of Bemotrizinol, the first new UV filter proposed in decades, signaling a significant push toward regulatory modernization.

The Core Shift: From "Ban" to "Data-Driven Evidence"

A common misconception is that the FDA is simply "banning" certain ingredients. In reality, the focus is on demanding robust safety data rather than issuing prohibitions.

The FDA categorizes active ingredients into two groups:

GRASE Confirmed: Ingredients like Zinc Oxide and Titanium Dioxide have sufficient evidence to support their safety and efficacy.
Pending Further Data: This includes most organic (chemical) UV filters. This does not mean they are "unsafe"; rather, the FDA requires higher-level clinical data to officially grant them GRASE status.

The goal is to increase transparency in the evaluation process and raise the safety bar for all sunscreens on the market.

Why the Emphasis on Labeling (PDP) for Sunscreen OTC?

The FDA is prioritizing the Principal Display Panel (PDP) to ensure consumers can make informed choices at a glance. Proposed changes include:

Alphabetical Listing: Active ingredients must be listed alphabetically.
Identity Statement: The word “Sunscreen” followed by the dosage form (e.g., Lotion, Spray) must be clearly stated.

These are currently considered guidelines for the future direction of labeling rather than final, immediate mandates, but brands should begin aligning with this structure.

Brand & Manufacturer Compliance Checklist

Review these 7 critical points to ensure your brand is ready for the evolving FDA landscape:

▶ Ingredient Review: Are you using non-mineral filters? (Prepare for potential requests for safety/absorption data).

▶ Labeling Structure: Does your PDP layout align with the FDA’s latest guidance for clear identification?

▶ Beyond SPF: Does your product meet the 'Broad Spectrum' requirements in addition to the SPF value?

▶ Dosage Forms: For sprays or powders, have you addressed additional safety points like inhalation exposure?

▶ Regulatory Mindset: Do you understand the update as a "Data-driven Re-evaluation" rather than a simple ban?

▶ Claim Risk Management: Are you confusing OTC regulatory terms with marketing claims on your packaging?

▶ Launch Timeline: Have you factored in sufficient time for labeling, testing, and drug listing review?

The essence of this FDA update is not about restricting brands; it is about building consumer trust through transparent data. Brands must proactively audit their ingredients, labeling, and marketing claims to ensure they meet the new standards of Compliance.

Reference | FDA Official Sources

This content is based on official documents from the FDA Federal Register and OTC Monographs.