On a US label: the Drug Facts box
In the US a sunscreen is an over-the-counter drug1, so it carries a Drug Facts label, set out in the same order as on every other over-the-counter medicine.2 Its first heading is "Active ingredient" or "Active ingredients", followed by the established name of each one and, for products such as lotions that have no fixed dosage unit, its proportion of the product.3 The FDA describes a sunscreen's active ingredients as the ones that protect the skin from UV, and its inactive ingredients as everything else, such as water or oil.1
The inactive ingredients come later in the box. When the product is also a cosmetic, as makeup or a moisturiser with sun-protection claims is, they are listed in descending order of predominance, like a cosmetic ingredient list.34 The FDA notes that many people do not turn a sunscreen bottle round to read the Drug Facts, and has proposed adding an alphabetical list of the active ingredients to the front of the pack. That proposal is not yet final.5
On an EU label: one list, no percentages
An EU sunscreen is a cosmetic6, so it has a single list headed "Ingredients", in descending order of weight down to 1%, with no separate place for the filters and no percentages (Article 19(1)(g)). The filters are the names listed in Annex VI, the only UV filters a cosmetic may contain (Article 14(1)(e)).7 A name followed by (nano) is a nanomaterial; the guide to mineral vs chemical sunscreen filters explains what that means for zinc oxide and titanium dioxide.
One filter brings its own warning. Where Benzophenone-3 is used in face, hand, lip or body products, the label must say "Contains Benzophenone-3", unless it is there at 0.5% or less only to protect the product (Annex VI, entry 4).7
Common UV filters, their names and their limits
The same filter often goes by two names: the EU glossary name on an EU list and the drug name in a US Drug Facts box. Annex VI gives the drug name for many of them alongside the chemical name.78
| EU label name | Other name | Annex VI entry | EU maximum | US maximum |
|---|---|---|---|---|
| Zinc Oxide | Zinc oxide | 30; nano form 30a | 25%, both forms together | 25% |
| Titanium Dioxide | Titanium dioxide | 27; nano form 27a | 25%, both forms together | 25% |
| Butyl Methoxydibenzoylmethane | Avobenzone | 8 | 5% | 3% |
| Octocrylene | Octocrylene | 10 | 10%; 9% in propellant sprays | 10% |
| Ethylhexyl Methoxycinnamate | Octinoxate | 12 | 10% | 7.5% |
| Ethylhexyl Salicylate | Octisalate | 20 | 5% | 5% |
| Homosalate | Homosalate | 3 | 7.34%, face products only, not propellant sprays | 15% |
| Benzophenone-3 | Oxybenzone | 4 | 6% in face, hand and lip products (not sprays); 2.2% in body products; 0.5% in others | 6% |
| Phenylbenzimidazole Sulfonic Acid | Ensulizole | 6 | 8% (as acid) | 4% |
| Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine | Bemotrizinol | 25 | 10% | 6%, since 2026 |
| Methylene Bis-Benzotriazolyl Tetramethylbutylphenol | Bisoctrizole | 23; nano form 23a | 10% | Not in the monograph |
| Diethylamino Hydroxybenzoyl Hexyl Benzoate | None given | 28 | 10% | Not in the monograph |
| Ethylhexyl Triazone | None given | 15 | 5% | Not in the monograph |
| Terephthalylidene Dicamphor Sulfonic Acid | Ecamsule | 7 | 10% (as acid) | Not in the monograph |
The US limits are those of the sunscreen monograph, with bemotrizinol added in 2026.89 The FDA's own list of sunscreen active ingredients also names ecamsule, which is not in the monograph18; outside a monograph, a drug generally needs FDA approval of an application.4 The FDA has also proposed that twelve of the monograph's ingredients, avobenzone and octocrylene among them, need more data; mineral vs chemical sunscreen filters covers that review.5
The lists change
- EU: 4-Methylbenzylidene Camphor, a UV filter10, is now in Annex II, the list of substances cosmetics must not contain (entry 1730). Products containing it could not be placed on the EU market from 1 May 2025, nor made available from 1 May 2026.7
- EU: products that do not meet the current Homosalate conditions may no longer be made available in the EU, since 1 July 2025; for Benzophenone-3 and Octocrylene, the transition under the earlier conditions ended on 28 July 2023.7
- US: bemotrizinol was added to the monograph by an order effective 9 August 2026.9 In September 2026 the FDA issued a final order removing PABA and trolamine salicylate; it says final orders on its 2021 proposals cannot take effect earlier than a year after they are issued.5
What the label cannot tell you
A list of filters is not a measure of protection. An SPF value comes from testing the finished product: the FDA describes a test that compares the UV exposure it takes to cause sunburn with and without the sunscreen.1 The European Commission's recommendation likewise says protection should be measured with standardised, reproducible methods, and that no product should claim 100% protection with words such as "sunblock" or "total protection".6 Two products with the same filters can differ in how much of each they contain, which an EU list never states, and in the rest of the formula.
The number on the pack also assumes a quantity. The Commission notes that SPF tests apply 2 mg/cm², more than people usually use, and that halving the amount may cut protection by as much as two-thirds.6
What to look for on the label
- US: the "Active ingredients" line in Drug Facts, with a percentage for each filter.3
- EU: Annex VI names in the ingredient list, under no separate heading.7
- "Contains Benzophenone-3": the warning required when that filter is used in face, hand, lip or body products.7
- A filter name in a product with no SPF claim: it may be there to protect the formula. The EU database separates a UV filter, which protects the skin or hair, from a UV absorber, which protects the product, and lists Octocrylene as both.1112 Either way, it must keep to its Annex VI conditions (Article 14(1)(e)(ii)).7
To see every filter on a list at once, paste it into the ingredient checker, which matches drug names such as Avobenzone and Octinoxate to their EU names.
Sources
- US Food and Drug Administration. Sunscreen: How to Help Protect Your Skin from the Sun (content current as of 10 September 2026). fda.gov Checked 11 October 2026.
- US Food and Drug Administration. The Over-the-Counter Drug Facts Label (content current as of 2 September 2026). fda.gov Checked 11 October 2026.
- US Code of Federal Regulations, Title 21, section 201.66: Format and content requirements for over-the-counter (OTC) drug product labeling, paragraphs (c)(2) and (c)(8) (electronic CFR, current text). ecfr.gov Checked 11 October 2026.
- US Food and Drug Administration. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) (content current as of 11 September 2024). fda.gov Checked 11 October 2026.
- US Food and Drug Administration. Questions and Answers: FDA's regulatory actions on over-the-counter sunscreen (content current as of 10 September 2026). fda.gov Checked 11 October 2026.
- Commission Recommendation 2006/647/EC of 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto: recitals 1 and 14, points 2, 5 and 9. Official Journal of the European Union L 265, 26.9.2006, p. 39 (in force). eur-lex.europa.eu Checked 11 October 2026.
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, consolidated text of 18 May 2026. The article or annex entry relied on is named in each sentence citing it. Official Journal of the European Union. eur-lex.europa.eu Checked 11 October 2026.
- US Food and Drug Administration. Final Administrative Order OTC000006: Over-the-Counter Monograph M020, Sunscreen Drug Products for Over-the-Counter Human Use (deemed final order, posted 24 September 2021), section M020.10, sunscreen active ingredients. accessdata.fda.gov Checked 11 October 2026.
- US Food and Drug Administration. Final Administrative Order OTC000039 amending Over-the-Counter Monograph M020 to add bemotrizinol (issued 10 June 2026, corrected 10 August 2026; effective 9 August 2026). accessdata.fda.gov Checked 11 October 2026.
- European Commission. CosIng entry 4-METHYLBENZYLIDENE CAMPHOR: INCI name, description, functions and cosmetics restriction (II/1730). ec.europa.eu Checked 11 October 2026.
- European Commission. CosIng: the functions of cosmetic ingredients and their definitions (83 functions), as the CosIng site serves them. ec.europa.eu Checked 11 October 2026.
- European Commission. CosIng entry OCTOCRYLENE: INCI name, description and functions. ec.europa.eu Checked 11 October 2026.
Written for this site from the sources above and checked against them on 11 October 2026. Not reviewed by a dermatologist or toxicologist, and not medical advice. Spotted something wrong? Tell us.