21 CFR Part 352 Sunscreen Rules: A Manufacturer's Guide

Sunscreen is a drug in the United States, not a cosmetic — and that single fact trips up more manufacturers than any other rule in this guide. I get some version of this question every few weeks from personal care companies, and lately it's been coming from UK and EU manufacturers who already sell SPF skincare successfully under European rules and assume the US will treat sunscreen the same way theirs does. It doesn't. If you manufacture or import sunscreen sold in the US, your product is regulated under 21 CFR Part 352, the FDA's sunscreen drug monograph, and it has to meet drug-level requirements for active ingredients, testing, labeling, and manufacturing — not the cosmetic GMP framework (ISO 22716) most SPF skincare brands are built around.

This guide walks through what Part 352 actually requires, where it sits inside FDA's broader OTC monograph system, and the specific place where global manufacturers most often get stuck: active ingredients that are legal and common in Europe but not permitted in a US-marketed sunscreen at all.

What Is 21 CFR Part 352, and Why Is It Marked "Stayed"?

21 CFR Part 352, "Sunscreen Drug Products for Over-the-Counter Human Use," is FDA's monograph for nonprescription sunscreen. A monograph is essentially a recipe book FDA maintains for a category of OTC drug: it lists which active ingredients are permitted, at what concentrations, in what combinations, with what labeling. A product that matches its category's monograph exactly can be marketed without FDA pre-approval of an individual New Drug Application (NDA). Sunscreen has been handled this way since FDA published the sunscreen final monograph on May 21, 1999 (64 FR 27666).

Here's the part that confuses people: if you pull up Part 352 on the eCFR today, it's flagged "[Stayed Indefinitely]." The 1999 final monograph was challenged and stayed before it ever took legal effect, and it sat in that limbo for two decades while FDA worked through additional safety and effectiveness data under the Sunscreen Innovation Act of 2014. So for most of Part 352's life, the regulation existed on paper without technically being enforceable in its own right — yet the industry operated under its terms anyway, because it was the only sunscreen rulebook FDA had published.

That changed with the CARES Act.

How the CARES Act Changed Sunscreen Regulation

The Coronavirus Aid, Relief, and Economic Security (CARES) Act, enacted March 27, 2020, added Section 505G to the Food, Drug, and Cosmetic Act and replaced the old notice-and-comment rulemaking process for OTC monographs with an administrative order process. As part of that transition, Section 505G created what FDA calls a "Deemed Final Order" for each existing OTC monograph — including sunscreen.

For sunscreen, the Deemed Final Order is defined as the requirements in 21 CFR Part 352 as published on May 21, 1999, combined with the labeling and effectiveness testing requirements at 21 CFR 201.327 as they stood on March 26, 2020, the day before the CARES Act took effect. In plain terms: the substance of the stayed 1999 monograph, plus the 2011 labeling and testing amendments, is now the enforceable standard for sunscreen — administered as an order rather than a stayed regulation. FDA can amend that order administratively, without a full rulemaking cycle, and it has already issued a proposed order (September 2021, docket FDA-1978-N-0018, formerly OTC000008) to update GRASE determinations, testing methods, and maximum labeled SPF values. Manufacturers should treat the current Deemed Final Order as binding today and watch the docket for the next administrative order, because FDA can finalize changes faster under Section 505G than it ever could under the old rulemaking track.

The 16 Permitted Sunscreen Active Ingredients

21 CFR 352.10 lists the only active ingredients a monograph sunscreen may contain, each capped at a specific maximum concentration. There are sixteen. No new UV filter has been added to this list since 1999 — a filter called Tinosorb S (bemotrizinol) has been under FDA review for data sufficiency for more than two decades without a final GRASE determination, which tells you how slowly this list actually moves.

Only two of the sixteen listed actives — zinc oxide and titanium dioxide — currently have FDA's confidence as GRASE without more data. Twelve remain in an "insufficient data" holding pattern, which means they're still lawfully usable under the current Deemed Final Order but carry regulatory uncertainty for long-term formulation planning. PABA and trolamine salicylate are proposed as not GRASE due to allergic reaction and anticoagulant-interaction risk, respectively, and a prudent manufacturer should already be formulating away from both.

Why European and UK Sunscreen Filters Don't Transfer to the US Market

This is where most of the calls I get from UK and EU manufacturers start. Europe regulates sunscreen as a cosmetic under EU Regulation 1223/2009, with its own annex of approved UV filters — including filters like Tinosorb S, Tinosorb M, Uvinul A Plus, and Mexoryl XL that give European formulators excellent broad-spectrum photostability. None of those four are on the 21 CFR 352.10 list. If your current UK formula relies on any of them, that formula cannot be sold in the US as a monograph OTC drug, full stop — you're not looking at a labeling fix, you're looking at reformulation with a US-permitted filter or filter combination.

This is precisely the situation the two SPF products referenced by UK-based inquiries into this firm were facing: products developed and manufactured to a strong European standard, already selling into other global markets, that needed a parallel US-compliant formulation before they could legally enter the American market. The efficient path is usually to build a second formulation early in development that uses only Part 352 filters (zinc oxide, titanium dioxide, avobenzone, octocrylene, octisalate, and homosalate are the common workhorse combination for broad-spectrum protection under the monograph) rather than trying to petition FDA for a new filter — that route runs through a Time and Extent Application (TEA) under the Sunscreen Innovation Act, and FDA has never completed one to a positive GRASE determination in the program's history.

SPF, Broad-Spectrum, and Water-Resistance Testing

Testing requirements live at 21 CFR 201.327, carried into the Deemed Final Order as it stood on March 26, 2020. Three tests matter for label claims:

• SPF test (21 CFR 201.327(i)): an in vivo human test measuring the ratio of UV energy needed to produce minimal erythema on protected versus unprotected skin. This sets the labeled SPF value.
• Broad Spectrum test (21 CFR 201.327(j)): an in vitro test measuring UVA protection relative to UVB protection. To claim "Broad Spectrum" on the label, the product must demonstrate a critical wavelength of at least 370 nm.
• Water resistance test: measures SPF retention after 40 minutes or 80 minutes of water immersion with specified activity. A product can claim "Water Resistant (40 minutes)" or "Water Resistant (80 minutes)" only if it passes the corresponding protocol — there is no unqualified "water resistant" claim and no time increment beyond 80 minutes.

The 2011 final rule that produced 21 CFR 201.327 also banned several claims outright: "waterproof," "sweatproof," "sunblock," and any claim of instant protection or protection lasting longer than two hours without reapplication. If your current labeling — UK, EU, or otherwise — uses any of those terms, it needs to come off before the product touches the US market. The compliance date for these labeling and testing requirements was December 17, 2012, for firms with sunscreen sales of $25,000 or more annually, so this isn't a new or transitional requirement — it's been enforceable for well over a decade.

Labeling Requirements and the Drug Facts Panel

Because sunscreen is an OTC drug, it needs a Drug Facts panel — the same standardized format used on OTC cough medicine and pain relievers, governed by 21 CFR 201.66. That panel must list active ingredients and their purpose, uses, warnings, directions, and inactive ingredients, laid out in the mandated format and type size. This is a materially different labeling structure than the ingredient-list-plus-claims format used on a cosmetic SPF product in most other markets, and it cannot simply be translated or resized from a EU cosmetic label — it has to be built from the Drug Facts template.

A few labeling specifics worth flagging for anyone converting a foreign SPF label:

• Under the current proposed order, products testing above SPF 50 would be capped at a labeled value of "50+," a limit FDA first proposed based on insufficient clinical data showing meaningfully greater protection above that threshold.
• Sunscreen combined with insect repellent in a single product is not GRASE under the monograph — FDA has stated combination sunscreen-repellent products raise safety and use-pattern concerns (repellent reapplied at sunscreen frequency) that the monograph does not resolve, so this combination category isn't marketable as an OTC monograph drug.
• "Broad Spectrum" and SPF value must appear together on the front label per the format FDA specifies; you can't make an SPF claim without also disclosing whether the product is broad spectrum.

Manufacturing Requirements: This Is Drug cGMP, Not Cosmetic GMP

Here's the second place global manufacturers get caught out. A facility making cosmetic SPF products to ISO 22716 is following a real, respected quality standard — but it is not the standard FDA requires for a drug. Sunscreen manufactured for the US market must be produced under 21 CFR Parts 210 and 211, the pharmaceutical current good manufacturing practice regulations that also govern prescription drug and generic drug manufacturing. That means formal batch production records, validated cleaning and equipment procedures, environmental and microbial controls appropriate to a drug facility, documented raw material and in-process testing, and a quality unit with independent authority over batch release — a materially higher documentation and validation burden than most cosmetic GMP programs carry today.

If your facility has never manufactured to 21 CFR 211 before, the gap analysis against your existing ISO 22716 system is usually the fastest way to see exactly where the burden lands — batch records and quality unit authority are almost always the two areas requiring the most rebuilding.

Facility Registration and Fees for Foreign Manufacturers

Any facility manufacturing an OTC monograph drug for the US market — domestic or foreign — must register with FDA under 21 CFR Part 207 and list each product with its NDC number before the product is introduced into interstate commerce. A foreign manufacturer additionally needs a US Agent designated with FDA, and the facility is subject to FDA inspection, including foreign facility inspections, the same as a US-based site.

Since the CARES Act, monograph drug facilities also owe an annual OTC Monograph Drug User Fee (OMUFA) facility fee, assessed per facility and published annually by FDA — this applies whether the facility is a Monograph Drug Facility (MDF) manufacturing the finished product or a Contract Manufacturing Organization (CMF) performing contract manufacturing. Budget for this fee before you commit to a US launch timeline; it's a recurring annual cost tied to the facility, not a one-time registration charge, and it's separate from any state licensing fees.

Compliance Checklist for Manufacturers Selling Sunscreen in the US

1. Confirm every active ingredient is on the 21 CFR 352.10 list, at or below its maximum concentration, and cross-check any ingredient currently in "insufficient data" status against FDA's latest proposed order.
2. Reformulate around any EU/UK-specific filter (Tinosorb, Uvinul A Plus, Mexoryl XL, etc.) that isn't on the US list — plan for a genuinely separate US formula, not a label swap.
3. Run SPF, Broad Spectrum, and (if claimed) water-resistance testing per 21 CFR 201.327 protocols, using a lab experienced with FDA's specific methodology.
4. Build a compliant Drug Facts panel under 21 CFR 201.66 — don't adapt a cosmetic ingredient label.
5. Scrub the label for prohibited claims: no "waterproof," "sweatproof," "sunblock," instant protection, or SPF value above 50+.
6. Bring manufacturing up to 21 CFR 210/211 cGMP, with batch records, validated processes, and an independent quality unit — not ISO 22716 alone.
7. Register the manufacturing facility under 21 CFR Part 207, list the product's NDC, and designate a US Agent if the facility is outside the US.
8. Budget for the annual OMUFA facility fee and for FDA facility inspection readiness.

Frequently Asked Questions

Is sunscreen a cosmetic or a drug in the United States?

Sunscreen is regulated as an over-the-counter drug in the US under 21 CFR Part 352, even when the identical formula would be classified as a cosmetic in the EU or UK. Any SPF claim triggers drug status, regardless of how the rest of the product is marketed.

Can I sell a sunscreen in the US that uses Tinosorb or Mexoryl XL?

Not as an OTC monograph drug. Those filters are not on the 21 CFR 352.10 list of permitted sunscreen active ingredients, so a product containing them does not meet the monograph and cannot be marketed under it. A reformulated US version using monograph-listed actives is the standard path.

What is the maximum SPF I can put on a US label?

Under FDA's current proposed order amending the sunscreen monograph, products testing above SPF 50 would be labeled "50+" rather than the actual tested number, based on FDA's determination that data doesn't clearly support greater real-world protection above that threshold.

Does my sunscreen facility need to follow drug GMP or cosmetic GMP?

Drug GMP. Sunscreen manufacturing for the US market falls under 21 CFR Parts 210 and 211, the same pharmaceutical cGMP framework used for other OTC and prescription drugs — ISO 22716 cosmetic GMP certification does not satisfy this requirement on its own.

Do foreign sunscreen manufacturers need to register with FDA?

Yes. Any facility manufacturing an OTC monograph drug for US distribution must register under 21 CFR Part 207, list its products, and — if located outside the US — designate a US Agent and remain subject to FDA facility inspection.

If your facility is navigating this transition from cosmetic GMP to drug cGMP, or you're trying to figure out which of your active ingredients survive a US reformulation, that gap assessment is exactly the kind of work we do for OTC drug manufacturers before they commit to a US launch date. You can see how we approach OTC drug compliance work on our OTC drug consulting page, and if a US facility inspection is on your near-term horizon, our FDA inspection preparation guidance covers what inspectors actually check once you're registered.

Last updated: 2026-08-11