In the US a sunscreen is an over-the-counter (OTC) drug: it may only use the active ingredients in FDA's monograph M020, must pass the SPF tests in 21 CFR 201.327, carries a Drug Facts label and is made in a drug-registered factory with a National Drug Code. In the EU and the UK it is a cosmetic that may only use the UV filters in Annex VI, with SPF and UVA protection tested to ISO methods and labeled by protection category. Australia and Canada treat most sunscreens as therapeutic products that need a listing or a product licence, while Korea reviews them as functional cosmetics and Japan labels them with SPF and PA under an industry standard.
Why sunscreen rules differ so much
A moisturizer is a cosmetic almost everywhere. A sunscreen is not, because it claims to protect against a health risk: sunburn and, in some markets, skin cancer. Each market answers the same question in its own way, "is sun protection a cosmetic benefit or a medical one?", and that answer decides who may sell the product, which filters it may use and how it is tested.
Three terms come up again and again:
- SPF (sun protection factor): how much longer protected skin takes to burn under UVB light than unprotected skin, measured in a lab. SPF 30 means about 30 times the UV dose to cause the same redness.
- UVA protection: protection against the longer rays linked to skin aging. It is shown as a ratio to SPF in the EU, as "Broad Spectrum" in the US and as a PA grade (PA+ to PA++++) in Korea and Japan.
- Critical wavelength: the wavelength below which 90% of the product's UV absorbance (from 290 to 400 nm) falls. A higher value means protection reaches further into the UVA range. Both the US and the EU use 370 nm as the pass mark.
A Korean SPF 50+ PA++++ sun cream that sells well in Seoul can be sold in the EU after a safety assessment and EU tests, but it usually cannot be sold in the US as it is, because its filters are not on the US list. Our blog post on why Korean sunscreen is not sold in the US tells that story; this guide gives you the full rule set per market.
Markets at a glance
| Market | Legal status | Filter list | Who files | Main tests |
|---|---|---|---|---|
| United States | OTC drug (monograph M020) | 17 active ingredients after June 2026, 2 of them being removed | Drug-registered factory lists the product; the brand is the labeler | SPF and broad spectrum to 21 CFR 201.327; water resistance if claimed |
| European Union | Cosmetic (Regulation 1223/2009) | Annex VI, with maximum strengths | EU Responsible Person, CPNP notification | SPF ISO 24444 or ISO 23675; UVA ISO 24443; critical wavelength |
| United Kingdom | Cosmetic (UK cosmetics regulation) | UK Annex VI | UK Responsible Person, SCPN notification | Same ISO methods as the EU |
| Australia | Therapeutic good if sun protection is the main purpose, or a secondary sunscreen over SPF 15 | TGA permitted ingredients | Australian sponsor lists it in the ARTG | AS/NZS 2604:2021 |
| Canada | Natural health product (NPN) or non-prescription drug (DIN) | Health Canada sunscreen monograph | Canadian applicant for the NPN or DIN | Monograph methods |
| South Korea | Functional cosmetic (MFDS) | MFDS permitted UV filters | The Korean responsible seller | SPF, water resistant SPF and PA data in the review |
| Japan | Cosmetic, or a quasi-drug if it makes quasi-drug claims | MHLW positive list | Japanese marketing license holder | SPF and PA to the JCIA voluntary standard (PA by ISO 24442) |
United States: sunscreen is an OTC drug
Under US law any product that claims to prevent sunburn is a drug. A moisturizer or foundation with SPF is both a cosmetic and a drug, and must meet both sets of rules. Most US sunscreens are sold without an approved drug application because they follow an OTC monograph: a published rule book that says which active ingredients, strengths, tests and label text make a product "generally recognized as safe and effective" (GRASE).
Since the CARES Act of 2020, monographs are FDA administrative orders rather than regulations. The sunscreen monograph is M020. Its base is the "deemed final order" (OTC000006) that the CARES Act created from the 1999 sunscreen monograph and the 2011 labeling and effectiveness rule, which still sits in the Code of Federal Regulations as 21 CFR 201.327. FDA can change M020 by new orders, and in 2026 it did so twice.
MoCRA, the 2022 cosmetics law, does not replace any of this. A sunscreen follows the drug rules: drug establishment registration, drug listing and drug GMP. If you sell cosmetics in the US as well, see our MoCRA compliance guide for the cosmetic side.
US filters and the 2026 changes
The deemed final order lists 16 sunscreen active ingredients. FDA added a 17th, bemotrizinol, by final order OTC000039 on June 10, 2026, and finalized the removal of two old ones, PABA (aminobenzoic acid) and trolamine salicylate, by final order OTC000008-1 on September 11, 2026. Under the CARES Act a final order of that kind cannot take effect sooner than one year after it is issued.
| Group | Ingredients | Status as of October 2026 |
|---|---|---|
| Proposed as GRASE in 2021 | Zinc oxide, titanium dioxide (up to 25%) | Listed. FDA's 2021 proposal found enough safety data for both. |
| Added in 2026 | Bemotrizinol (INCI: bis-ethylhexyloxyphenol methoxyphenyl triazine), up to 6% | Listed by final order OTC000039. For 18 months from its August 9, 2026 effective date, marketing under the order is reserved for the company that asked for it and its licensees. |
| Need more data (2021 proposal) | Avobenzone, cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, oxybenzone, padimate O, sulisobenzone | Still listed and usable. The 2021 proposal asks for more safety data; FDA says this does not mean they are unsafe. |
| Being removed | PABA, trolamine salicylate | Not GRASE by final order OTC000008-1 (September 2026) |
What about "the 2024 proposed order"? We found no 2024 sunscreen proposed order. The open proposal is the 2021 proposed order (OTC000008), which would also require broad spectrum protection for every sunscreen of SPF 15 and up, add a UVA I to UV ratio of 0.7 or higher, cap the labeled SPF at 60+ and limit the dosage forms. FDA received over 15,000 comments on it and says it will finalize the rest in future orders; there is no deadline. The bemotrizinol proposal was published in December 2025 and finalized in June 2026. Until FDA finalizes more, the deemed final order and 21 CFR 201.327 are the rules you test and label to.
The filters that give many Korean and European sunscreens their light feel, such as bisoctrizole, diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl triazone, diethylhexyl butamido triazone, drometrizole trisiloxane and polysilicone-15, are not on the US list. One of them in the formula makes the whole product an unapproved drug in the US. The monograph also limits combinations: for example avobenzone may not be combined with zinc oxide or titanium dioxide.
US SPF, broad spectrum and water resistance tests
21 CFR 201.327 sets the tests behind every number and phrase on a US sunscreen label.
- SPF test on people
A lab applies 2 mg of product per square centimeter of skin on the back of volunteers with skin types I, II or III, exposes small sites to a solar simulator and reads the redness the next day. The panel must produce at least 10 valid results, and the labeled SPF is the mean minus a statistical margin, rounded down. A reference sunscreen runs alongside to prove the test worked.
- Broad spectrum test in vitro
The product is spread on roughened PMMA plates, pre-irradiated, and its absorbance measured from 290 to 400 nm. A mean critical wavelength of 370 nm or more passes. Only then may the label say "Broad Spectrum SPF".
- Water resistance, if you claim it
The SPF is tested again after water immersion: 40 minutes (two 20-minute sessions with a rest) for "water resistant (40 minutes)", or 80 minutes for "water resistant (80 minutes)". There is no other approved time and no "waterproof".
SPF testing to the US method is done by specialized clinical labs, takes several weeks and is priced per product, so plan it before you order packaging. The SPF printed must be the tested value for the final formula; a change in filters or base means a new test. More on how in vivo and in vitro methods compare in SPF testing: in vivo vs in vitro.
The Drug Facts label
Every US OTC drug carries a Drug Facts panel in the format of 21 CFR 201.66, with fixed headings in a fixed order and minimum type sizes. For a sunscreen the content comes from 201.327.
| Heading | What goes in it for a sunscreen |
|---|---|
| Active ingredients | Each filter with its percentage, for example "Zinc oxide 20%" |
| Purpose | "Sunscreen" |
| Uses | "helps prevent sunburn"; for Broad Spectrum SPF 15 and up, the optional statement that, used as directed with other sun protection measures, it decreases the risk of skin cancer and early skin aging caused by the sun |
| Warnings | "For external use only", "Do not use on damaged or broken skin", "When using this product keep out of eyes. Rinse with water to remove.", "Stop use and ask a doctor if rash occurs", "Keep out of reach of children". Products under SPF 15, or not broad spectrum, add the Skin Cancer/Skin Aging Alert. |
| Directions | Apply liberally 15 minutes before sun exposure, reapply at least every 2 hours (or after the tested water time), plus the sun protection measures text |
| Other information | "protect the product in this container from excessive heat and direct sun" |
| Inactive ingredients | All other ingredients |
| Questions or comments? | Optional phone number |
The front panel shows "Broad Spectrum SPF" with the number (or just "SPF" if it fails the broad spectrum test) and any water resistance time. The label also names the labeler and the country of origin, and the product carries an expiration date unless stability data show at least 3 years. Our label requirements by country guide covers the rest of the US label.
Drug establishment registration, NDC and drug GMP
This is the step most first-time brands do not expect. A US sunscreen must be made in a factory that is set up for drugs, not only for cosmetics.
- Drug establishment registration
Under 21 CFR part 207 the manufacturing site registers with FDA as a drug establishment every year. A factory outside the US names a US agent. A cosmetic facility registration under MoCRA does not count.
- Drug listing and NDC
Each product is listed with FDA in structured product labeling (SPL) format and gets a National Drug Code, the number printed on the label and used by retailers. The labeler code in the NDC belongs to the company that lists it.
- Drug GMP
Production follows current good manufacturing practice for finished drugs, 21 CFR parts 210 and 211: validated processes, release testing of every batch against the active ingredient strength, stability programs and written procedures. FDA can inspect foreign drug sites.
- OMUFA facility fee
Owners of OTC monograph drug facilities pay a yearly fee to FDA. For fiscal year 2027 (October 1, 2026 to September 30, 2027) it is $47,891 per facility, or $31,927 for a contract manufacturing organization facility.
EU and UK: sunscreen is a cosmetic
In the EU a sunscreen is a cosmetic under Regulation (EC) No 1223/2009. That makes it simpler to sell than in the US, but not loose:
- Filters: only the UV filters in Annex VI, each within its maximum concentration and conditions. In 2022 the EU lowered the limits for benzophenone-3 (oxybenzone), octocrylene and homosalate, so older formulas need a check against the current annex.
- Safety: a Cosmetic Product Safety Report (CPSR) signed by a qualified safety assessor, a Product Information File (PIF), an EU Responsible Person and a CPNP notification before sale. See our EU cosmetics regulation guide and what a CPNP number is.
- Efficacy and labels: Commission Recommendation 2006/647/EC. It is a recommendation, not a regulation, but authorities and retailers treat it as the rule for sunscreen claims.
The Recommendation asks for:
| Category on the label | Labeled SPF |
|---|---|
| Low protection | 6, 10 |
| Medium protection | 15, 20, 25 |
| High protection | 30, 50 |
| Very high protection | 50+ (a measured SPF of 60 or more) |
- A UVA protection factor of at least one third of the labeled SPF, and a critical wavelength of at least 370 nm. Products that meet this commonly carry the circled "UVA" logo.
- No claims of total protection, such as "sunblock", "total protection" or "all day protection", and no claim that the product needs no reapplication.
- Warnings and directions: do not stay too long in the sun even with a sunscreen, keep babies and young children out of direct sunlight, apply before exposure and reapply often, and reduced quantity lowers protection.
The UK follows the same model under its own cosmetics regulation: a UK Responsible Person, notification on SCPN, a safety report, and the UK version of Annex VI. Since 2021 the UK and EU annexes can change on different dates, so check both lists when one formula serves both markets. Our UK cosmetics regulation guide has the details.
ISO test methods, old and new
| Standard | What it measures | How | Notes |
|---|---|---|---|
| ISO 24444 | SPF | In vivo, on volunteers | The long-standing reference method in the EU, UK, Asia and Australia |
| ISO 23675:2024 | SPF | In vitro, double plate method | Published December 2024; for emulsions and alcoholic one-phase products, not powders, compressed products or sticks; does not measure water resistance |
| ISO 23698:2024 | SPF, UVA protection factor and critical wavelength | Hybrid diffuse reflectance spectroscopy (HDRS): light on skin, no sunburn needed | Published December 2024; for emulsions and single-phase products |
| ISO 24443 | UVA protection factor and critical wavelength | In vitro, on plates | The usual EU method for the one third rule |
| ISO 24442 | UVA protection factor | In vivo, persistent pigment darkening | The basis of the PA grade in Japan and Korea |
| 21 CFR 201.327 | SPF, broad spectrum, water resistance | In vivo SPF, in vitro critical wavelength | US only; ISO results do not replace it |
The new in vitro methods avoid exposing volunteers to UV, but not every market or retailer accepts them yet, and the US accepts only its own method. Ask your safety assessor or importer which method they will accept before you book the lab. The deeper comparison is in SPF testing in vivo vs in vitro, and every test we arrange is listed in skincare product testing.
Australia
The Therapeutic Goods Administration (TGA) regulates a sunscreen as a therapeutic good when sun protection is its main purpose (a primary sunscreen), and also some secondary sunscreens, such as a moisturizer with an SPF over 15. These products must be entered in the Australian Register of Therapeutic Goods (ARTG) by an Australian sponsor, usually as a listed medicine with an AUST L number. They must come from a manufacturer that the TGA has licensed or, for a site abroad, given a GMP clearance, and they must be tested and labeled to the Australian and New Zealand standard AS/NZS 2604:2021, which allows labels up to SPF 50+.
Cosmetic sunscreens, such as moisturizers with SPF 4 to 15 in packs of 300 mL or less that make no water resistance or skin cancer claims, stay outside the ARTG but still follow the standard's tests and labels. Our Australia cosmetics guide covers AICIS and the rest.
Canada
In Canada a product with sun protection claims is not a plain cosmetic: it needs market authorization from Health Canada before sale. Health Canada's Primary Sunscreen Monograph (current version dated February 27, 2026) sets the permitted medicinal ingredients, strengths, label text and test methods:
- A primary sunscreen that contains only the monograph's natural health product ingredients (Table 1) is a natural health product and gets a Natural Product Number (NPN).
- One that contains any ingredient from Table 2 is a non-prescription drug and gets a Drug Identification Number (DIN).
- A makeup or skincare product with limited sunscreen claims is a secondary sunscreen; it is also an authorized product, not a plain cosmetic.
Nano titanium dioxide and nano zinc oxide are supported by the monograph when the product does not lead to inhalation. A Canadian applicant, usually the importer or brand's Canadian entity, files. See our Canada cosmetics guide.
Korea and Japan
Korea. A sunscreen is a functional cosmetic: a cosmetic whose function the Ministry of Food and Drug Safety (MFDS) reviews before sale. The Korean responsible seller either reports the product, when its ingredients and strengths match the MFDS standard notices, or applies for a full review with safety, efficacy, SPF, water resistant SPF and PA data. The full review takes about 60 days, with an application fee of KRW 189,000 online (as of October 2026). PA grades run from PA+ to PA++++, where PA++++ means a UVA protection factor of 16 or more. More in our Korea guide.
Japan. A sunscreen is normally a cosmetic, sold through a Japanese company that holds a cosmetics marketing license, and its UV filters must be on the MHLW positive list. SPF (up to 50+) and PA labeling follow the Japan Cosmetic Industry Association (JCIA) standard, a voluntary industry rule rather than a law, with PA measured in vivo to ISO 24442. Claims beyond cosmetic ones, for example preventing spots and freckles caused by sunburn, make it a quasi-drug that needs approval before sale. See our Japan guide.
Sunscreen claims you cannot make
| Claim | US | EU and UK |
|---|---|---|
| "Sunblock" | False and misleading under 201.327(g) | Not to be used (Recommendation 2006/647/EC) |
| "Waterproof", "sweatproof" | False and misleading; use "water resistant (40 or 80 minutes)" if tested | Use "water resistant" only with a recognized test |
| "Total protection", "100% protection", "all day protection" | Misleading | Not to be used |
| "Prevents skin cancer" | Only the permitted risk statement for Broad Spectrum SPF 15 and up, used with other sun protection measures | Avoid; it is a medicinal claim |
| "SPF 100" | Allowed today if tested; the 2021 proposal would cap labels at 60+ | Label "50+" for any measured SPF of 60 or more |
| "Reef safe", "reef friendly" | Not defined by FDA; needs substantiation under FTC rules | Must meet the claims criteria of Regulation 655/2013 |
Claims rules in general, including environmental claims like "reef safe", are in what skincare claims you can make, and the advertising side is in FTC and ASA advertising rules. For where other products cross into drug territory, see cosmetic vs drug claims.
Plan a sunscreen launch step by step
- List every market, including later ones
One formula can often serve the EU, the UK and much of Asia. The US almost always needs its own formula, and Australia and Canada need a local sponsor or applicant. Decide this before formulation, not after.
- Pick the filter set per market
Check each filter against M020 (US), Annex VI (EU and UK), the TGA and Health Canada lists, and the MFDS and MHLW lists. Note the maximum strengths, which differ.
- Write the claim list
SPF target, UVA grade (PA, UVA logo or Broad Spectrum), water resistance, skin type claims. Every claim maps to a test.
- Approve lab samples and run stability
Sunscreen filters can crystallize or separate, so stability and packaging compatibility matter more than for a serum. Expect about 2 to 4 weeks to first samples with us, longer for a new US formula.
- Book SPF and UVA tests on the final formula
Test the exact formula you will sell. Allow several weeks and budget per product and per method; a US and an EU version are two test programs.
- File before sale
US: drug establishment registration, listing and NDC. EU and UK: CPSR, PIF, Responsible Person and notification. Australia: ARTG listing. Canada: NPN or DIN. Korea: functional cosmetic report or review.
- Print labels after the test report
Never print the SPF before the result. Drug Facts, protection category, PA grade and warnings all depend on it.
- Plan shipping
Spray sunscreens with propellant are dangerous goods by air; creams and lotions usually are not. See shipping aerosols and alcohol-based cosmetics.
- Importing a Korean or EU sunscreen into the US unchanged. Its filters make it an unapproved drug, and FDA can detain it at the border.
- Assuming a MoCRA cosmetic facility registration covers a sunscreen. Drugs need drug establishment registration, listing and drug GMP.
- Printing "SPF 50" before the test. The number is whatever the final formula measures.
- Using "sunblock", "waterproof" or "all day protection" on any market's label.
- Treating an SPF moisturizer as a plain cosmetic in Australia or Canada. Above SPF 15 in Australia, and with any sun claim in Canada, it needs authorization.
- Testing one market's method and expecting another market to accept it, for example ISO 24444 results for a US label.
- Forgetting that 2022 EU limit changes for oxybenzone, octocrylene and homosalate apply to older formulas too.
- Every target market listed, with the legal status of sunscreen there
- Filter set checked against each market's list and maximum strength
- Claim list written: SPF, UVA grade, water resistance, skin type claims
- Stability and packaging compatibility done on the final formula
- SPF and UVA tests booked with a method each market accepts
- US: drug-registered factory, US agent, NDC, drug GMP and the OMUFA fee planned
- US: Drug Facts panel laid out to 21 CFR 201.66 and 201.327
- EU and UK: CPSR, PIF, Responsible Person and CPNP or SCPN notification
- EU and UK: protection category, UVA logo rule and Recommendation warnings on the label
- Australia: ARTG sponsor and AS/NZS 2604:2021 testing, if in scope
- Canada: NPN or DIN route chosen with a Canadian applicant, if in scope
- No "sunblock", "waterproof", "sweatproof" or "total protection" anywhere
- Labels printed only after the final test report
How KoreanOEM helps
We develop and produce Korean sunscreens: our formulation chemists in Busan build the formula. Production runs at an ISO 22716 certified facility in Pyeongtaek with our own staff on site. We start from the market you sell in, so the filter set fits the rules before samples are made.
- SPF 50+ PA++++ textures (creams, milks and gels; chemical, mineral or hybrid) from 10,000 units. See private label sunscreen.
- SPF and PA tests arranged through accredited partner labs and quoted per product, for the method your market accepts.
- US sunscreen is an OTC drug, so we quote it case by case: filters, tests and the drug paperwork change the cost and the timeline. Tell us early if you want a US version.
- EU and UK: CPSR and PIF through our partner for USD 1,250 per formula (UK notification included), CPNP notification USD 420 per product, Responsible Person USD 240 (UK) or USD 335 (UK and EU) per product per year. All fees are on fees.
- COA and microbiology for every batch, MSDS, specification, and a label proof check against your market's rules before printing. See label proof check and certifications.
Frequently asked questions
Is sunscreen a drug or a cosmetic?
Which sunscreen filters are allowed in the US in 2026?
Is there a 2024 FDA proposed order for sunscreen?
What does broad spectrum mean on a US sunscreen?
Can a sunscreen be called waterproof?
What does the EU UVA logo require?
Are in vitro SPF tests accepted now?
Do SPF moisturizers need a TGA listing in Australia?
What is the minimum order for a private label sunscreen at KoreanOEM?
Sources
- FDA: Questions and answers on FDA's regulatory actions on OTC sunscreen
- FDA: OTC Monographs@FDA (M020 and its orders)
- Federal Register: Final order OTC000039, bemotrizinol (June 10, 2026)
- Federal Register: Proposed order to add bemotrizinol (December 12, 2025)
- Federal Register: Final order OTC000008-1, PABA and trolamine salicylate (September 11, 2026)
- eCFR: 21 CFR 201.327, sunscreen labeling and effectiveness testing
- eCFR: 21 CFR 201.66, Drug Facts format and content
- eCFR: 21 CFR part 207, drug establishment registration and listing
- eCFR: 21 CFR part 211, GMP for finished pharmaceuticals
- FDA: Electronic Drug Registration and Listing System
- Federal Register: OTC Monograph Drug User Fee Rates for Fiscal Year 2027
- EUR-Lex: Regulation (EC) No 1223/2009, Annex VI (UV filters)
- EUR-Lex: Commission Recommendation 2006/647/EC on the efficacy of sunscreen products and claims
- COSlaw.eu: New ISO standards for SPF testing (ISO 23675 and ISO 23698)
- GOV.UK (OPSS): Making cosmetic products available to consumers in Great Britain
- TGA: Sunscreen regulation in Australia
- Health Canada: Primary Sunscreen Monograph (February 27, 2026)
- MFDS: Functional cosmetics and their evaluation
- ChemLinked: Japan revises the sun protection test methods (JCIA standard)
Checked against these sources in October 2026. Rules and fees change; check with the authority or your importer before you sell.