Octocrylene in EU Sunscreen

The SCCS opinion of 30-31 March 2021 (SCCS/1627/21) found that octocrylene is safe as a UV filter at up to 10% when used on its own. In combined use it was safe at 10% in every product type except sunscreen propellant sprays, which it found safe only at up to 9% ^[5][6][8]. It did not find octocrylene to be an endocrine disruptor. It said the data on that question were not conclusive enough to use in the safety assessment.

Why it was assessed After concerns about possible endocrine-disrupting properties, the Commission launched a call for data in 2019 and asked the SCCS to assess the evidence that came in ^[4].

How the risk was calculated (as summarised in the GB SAG-CS opinion)

• Starting point: a NOAEL of 153 mg/kg bw/day from an extended one-generation reproductive toxicity study in rats. Assuming 50% oral bioavailability, this gives an adjusted NOAEL of 76.5 mg/kg bw/day ^[9].
• Each product on its own: 10% octocrylene was safe in lipstick, face cream, hand cream, sunscreen cream/lotion, sunscreen propellant spray and sunscreen pump spray ^[9].
• Combined use: the scenario was lipstick plus face cream plus hand cream plus one form of sunscreen.
  • It was safe when the sunscreen was a cream/lotion or a pump spray.
  • When the sunscreen was a propellant spray at 10%, the margin of safety fell below 100. Cutting the spray to 9% brought it back above 100 ^[9][10].

Endocrine disruption Some in vivo studies suggested endocrine effects. However, the SCCS found the data not conclusive enough to set an endocrine-specific point of departure for the assessment ^[10].

What the Commission did with it The Commission concluded that the concentrations allowed at the time posed a potential risk to human health. Regulation (EU) 2022/1176 therefore set the maximum concentrations the SCCS had proposed ^[11]. This is where the 9% (propellant spray) and 10% (other products) limits come from.

The GB view (December 2023) The UK's Scientific Advisory Group on Chemical Safety of consumer products (SAG-CS) reached a different conclusion: octocrylene is acceptable at up to 10% both on its own and in combination ^[12].

• Why the difference: its combined-use margin of safety was 106. It used a 70 kg default adult body weight, where the SCCS would use 60 kg ^[13].
• Other points it noted:
  • Octocrylene can break down to benzophenone, which should be kept at trace levels ^[10].
  • It found no genotoxicity ^[14].
  • 27-80% of patients who are photoallergic to ketoprofen also react to octocrylene ^[13].
  • Children and adolescents should get a full risk assessment once adequate data are available ^[12].

Approach: I worked from the recitals of Regulation (EU) 2022/1176 and the GB SAG-CS Opinion 15 on octocrylene, which quotes and summarises the SCCS opinion. The full text of SCCS/1627/21 is not in the datasets I can search, so the method details above come from the SAG-CS summary of it.

Yes. In Great Britain octocrylene is still an authorised UV filter, and the GB limit is less strict than the EU one: 10% (as acid) in the ready-for-use product, for every product type. GB has no separate 9% cap for propellant sprays. That is entry 10 of Annex VI to the GB-retained Cosmetics Regulation 1223/2009, in the legislation.gov.uk text current to 15 July 2026 ^[15].

The GB entry compared with the EU entry

	GB Annex VI, entry 10	EU Annex VI, entry 10 (from my previous answer)
Propellant spray products	10% (as acid)	9%
All other products	10% (as acid)	10%
Benzophenone trace-level footnote	Not in the GB entry	Footnote 7

• The GB entry is still the original single limit. The EU split came from Regulation (EU) 2022/1176. The GB entry has no product-type breakdown, no other conditions and no warning wording ^[15].
• GB has changed other UV filters. Entry 4 (Benzophenone-3) now has split limits by product type: 2.2%, 6% and 0.5% ^[16]. So keeping octocrylene at a flat 10% is a GB choice, not just an amendment that hasn't happened yet.

Why GB kept 10%

• Call for data: in April 2022 the Office for Product Safety and Standards (OPSS) issued a call for data on cosmetic ingredients suspected of endocrine-disrupting properties, octocrylene among them. It then asked the SAG-CS to review the substance ^[17].
• Conclusion (December 2023): the SAG-CS found octocrylene acceptable at up to 10% both on its own and in combination ^[12].
• Why it differs from the SCCS: its combined-use margin of safety was 106. It used a 70 kg adult body weight, where the SCCS uses 60 kg ^[13].
• Points left open:
  • It wants a full risk assessment for children and adolescents once adequate data are available ^[12].
  • It noted that octocrylene breaks down to benzophenone, which should be monitored and kept at trace levels ^[10]. That point appears in the opinion but not as a condition in the GB Annex VI entry.
• No CMR trigger in GB: the opinion records no human-health harmonised classification under GB CLP. It also records no GB mandatory classification entry, as of December 2022 ^[18].

Northern Ireland is different The GB-retained Regulation refers to the EU Cosmetics Regulation "as it has effect by virtue of the Protocol on Ireland/Northern Ireland" ^[19]. Northern Ireland therefore runs on the EU text, which means the EU 9% (propellant spray) and 10% (other products) limits.

Article 5A treats a Northern Ireland-established responsible person as meeting most GB obligations if two conditions are met: they comply under the EU Regulation, and the product is "qualifying Northern Ireland goods" ^[19].

In practice, a sunscreen spray at 9% octocrylene or less meets both regimes. One at more than 9% and up to 10% is fine in GB but not in Northern Ireland or the EU.

Approach: I checked Annex VI and Article 5A of the GB-retained Cosmetics Regulation (legislation.gov.uk text current to 15 July 2026) and the GB SAG-CS Opinion 15 on octocrylene.

Yes. In the US, octocrylene is permitted as a sunscreen active ingredient at up to 10 percent under FDA's OTC Monograph M020 (Sunscreen Drug Products for Over-the-Counter Human Use), item § M020.10(k). The current version took effect on 9 August 2026 (M020, p.1-2). The US limit is a single 10% for every dosage form, including sprays, as in GB. The EU has a separate 9% cap for propellant sprays. However, FDA has formally proposed that octocrylene is not generally recognised as safe and effective (GRASE), because the data are insufficient. That proposal has not been finalised.

How the US regulates it (a drug, not a cosmetic)

• In the US, a sunscreen is an OTC drug. FDA's cosmetics list states that "sunscreen" or similar sun-protection wording on a label generally makes the product a drug or a drug/cosmetic. A cosmetic can contain a sunscreen ingredient only to protect the product's colour, and the label must then say so, for example "Contains a sunscreen to protect product color." Without that statement it may be regulated as a drug (21 CFR 700.35) ^[20].
• Under M020, an OTC sunscreen is GRASE and not misbranded if it meets every condition in the monograph and the general conditions in 21 CFR 330.1 (M020 § M020.1).
• Combinations: octocrylene, item (k), can be combined with the other listed filters at their own maximum concentrations. Each active must contribute at least SPF 2, and the finished product needs a minimum SPF of at least 2 times the number of actives (§ M020.20) (M020, p.3).
• What the current monograph reflects: Final Administrative Order OTC000006 (posted 24 September 2021) together with Final Administrative Order OTC000039 (10 June 2026). OTC000039 added bemotrizinol up to 6%, with 18 months of exclusivity for DSM. It left the octocrylene entry unchanged (M020, p.1).

The open safety question (Proposed Order OTC000008, 24 September 2021)

• FDA proposed that 12 filters, octocrylene among them, are "not GRASE due to insufficient data". It noted that nearly all of them have insufficient or no data on absorption (OTC000008, p.7).
• FDA said explicitly that this "does not represent a conclusion by FDA that the sunscreen active ingredients ... are unsafe". It is asking for more data because sunscreen use and exposure have risen sharply (p.5).
• After the 2019 proposed rule, FDA received a request to defer action on octocrylene and seven other filters while industry generated the data (p.2). FDA said it could defer a final order on an ingredient, initially for up to one year, if studies make timely progress. If they don't, it expects to proceed to a final order (p.4-5).
• The US concern is about the gap in safety data (absorption, carcinogenicity, reproductive toxicity) (p.6-7). The EU concern was a specific combined-exposure margin for propellant sprays.

Market reality FDA's NDC Directory lists 2,675 marketed drug products that contain octocrylene. Of these, 2,609 are listed as "OTC monograph drug" under M020 ^[21][22]. A few listings still cite the old 21 CFR part 352 ^[23]. Most products using it are combinations, for example avobenzone, homosalate, octisalate and 10% octocrylene in an aerosol spray ^[24].

Approach: I searched FDA's NDC Directory and FDA's list of prohibited and restricted cosmetic ingredients, and read the current OTC Monograph M020 and Proposed Order OTC000008 on FDA's OTC Monographs@FDA portal. I did not check state-level rules (for example state reef-safe sunscreen laws); I can look those up next if useful.