# OCTOCRYLENE (octocrylene) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/octocrylene
- **Standard INCI**: `OCTOCRYLENE`
- **KR MFDS Standard Name**: `옥토크릴렌`
- **CAS No.**: `6197-30-4`
- **EC / EINECS No.**: `228-250-8`
- **Origin**: `synthetic`
- **Functions**: 자외선차단제, 광안정제
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 옥토크릴렌 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | OCTOCRYLENE |
| US (PCPC / MoCRA INCI) | OCTOCRYLENE |
| US (FDA OTC Monograph) | OCTOCRYLENE |
| CN (NMPA IECIC) | 奥克立林 |
| JP (JCIA / MHLW QD) | OCTOCRYLENE  |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `restricted`
- **EU (1223/2009)**: `restricted`
- **US (FDA/MoCRA)**: `restricted`
- **CN (NMPA IECIC)**: `restricted` (Entry: `1062`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`

- **KR** [limited]: ≤ 10% —  (화장품 사용제한 원료 정보 (식약처 오픈API · 안전기준 [별표2]))
- **EU** [limited]: ≤ 10% —  (Regulation (EC) No 1223/2009 Annex VI — via CosIng (EU Commission))
- **CN** [limited]: ≤ 10% —  (化妆品安全技术规范(2015년판) — 表5)
- **CN** [limited]: ≤ 10% —  (化妆品安全技术规范（2015年版）)
- **US** [restricted]: ≤ 10% — [US RESTRICTED] * 【Restrictions】
Maximum Concentration (제한) : 10% 
* Specific Limitations  and Comments : Use of the term "sunscreen" or similar sun protection wording in a product's labeling generally causes the product to be subject to regulation as a drug or a drug/cosmetic, depending on the claims. However, sunscreen ingredients may also be used in some cosmetic products to protect the products’ color. The labelling must also state why the sunscreen ingredient is used, for example, "Contains a sunscreen to protect product color." If this explanation isn’t present, the product may be subject to regulation as a drug (21 CFR 700.35). For more information on sunscreens, refer to Tanning Products 
* 특별 제한조건 : "선스크린"의 단어를 사용하거나 자외선 차단과 비슷한 단어를 사용할 경우, 해당 제품은 클레임(표시광고)에 따라 제약 또는 제약/화장품의 규정을 따라야 한다. ^그러나, 자외선 차단의 성분들은 제품의 색을 보호하는 역할로 사용되기도 한다. 자외선을 차단하는 성분이 사용된 목적에 대해 라벨링에 반드시 명시해야한다. 예를 들어, "제품의 색을 보호하기 위해 자외차단제 성분을 함유하고 있다." ^만약 이러한 설명을 라벨링에 하지 않는다면, 그 상품은 제약으로서의 규정에 따라야한다. (21 CFR 700.35) ^자외선 차단에 대한 정보가 궁금하면 태닝 제품을 참고하라. (식약처 국가별 사용제한원료정보 API (미국))
- **KR** [noted]: ≤ 10% —  (기능성화장품 심사에 관한 규정 [별표4] 자료제출이 생략되는 기능성화장품의 종류(제6조제3항 관련))

## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- Listed within general cosmetic GMP safety thresholds.

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 4 – 8
- **Max Process Temp**: ≤ 50°C
- **Synergy Pairings**: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL
- **Incompatibilities**: Verify phase compatibility under extreme pH or high electrolyte loads

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: OCTOCRYLENE | CAS No.: 6197-30-4 | EC No.: 228-250-8
  - Origin: SYNTHETIC | Functions: , 
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: non-ionic | CosIng/MFDS 
  - Official Regional Label Names: US [OCTOCRYLENE] · EU [OCTOCRYLENE] · CN [奥克立林] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Octocrylene is the substituted acrylate that conforms to the formula Classified under origin 'synthetic', it acts within the cosmetic vehicle or stratum corneum to deliver ,  performance and structural formulation stability.
■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)]
  - Regional Summary: KR: RESTRICTED | EU: RESTRICTED | US: RESTRICTED | CN: RESTRICTED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 1062 (奥克立林))
  - [CN / COMPOSITION / limited] (Max 10%): 
  - [CN / COMPOSITION / limited] (Max 10%): 
  - [KR / COMPOSITION / limited] (Max 10%): 
  - Official Safety & Historical Use Concentration (Layer 2): Quantum satis (QS) within standard cosmetic safety margins
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [sun_color] Typical range: 2.0 ~ 10.0% (Median 4.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=33, EVONIK 14 · GRANT 13 · SEPPIC 6)) — Sun care & color cosmetics dispersion / sensory modifier
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Water Phase or Cool-down Phase (< 45°C)
  - Optimal pH Range: pH 4.0 ~ 8.0 | Max Process Temp: Max 50°C | Electrolyte Tolerance: MEDIUM
  - Incompatibility / Caution: Verify phase compatibility under extreme pH or high electrolyte loads
  - Synergy Pairings: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL | Reference Trade Names: OCTOCRYLENE
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 31588614 (2019, J Eur Acad Dermatol Venereol): Review of the safety of octocrylene used as an ultraviolet filter in cosmetics.
  - PMID 42167390 (2026, Environ Toxicol Pharmacol): UV-protective agents threaten bivalve reproduction: Impacts of octocrylene and benzophenone on gamete quality and fertil
  - PMID 41985167 (2026, Cutan Ocul Toxicol): Leveraging a TRPV1-overexpressing cell model: an integrated testing strategy for UV filter-induced ocular irritation

## 6. Linked PubMed Literature
- [PMID: 31588614] Review of the safety of octocrylene used as an ultraviolet filter in cosmetics. — *J Eur Acad Dermatol Venereol* (2019)
- [PMID: 42167390] UV-protective agents threaten bivalve reproduction: Impacts of octocrylene and benzophenone on gamete quality and fertilization in the Pacific oyster (Magallana gigas) — *Environ Toxicol Pharmacol* (2026)
- [PMID: 41985167] Leveraging a TRPV1-overexpressing cell model: an integrated testing strategy for UV filter-induced ocular irritation — *Cutan Ocul Toxicol* (2026)
- [PMID: 41726609] In Silico Perspective on Avobenzone, Octisalate, Octocrylene, Homosalate, and Bemotrizinol as Organic UV Filters Using DFT, TD-DFT, and Molecular Dynamics — *ACS Omega* (2026)
- [PMID: 41712751] Probabilistic emissions model for organic UV filters released to recreational waters during swimming/bathing events — *Environ Toxicol Chem* (2026)
- [PMID: 42309282] Allergic Contact Dermatitis to Personal Care Products: A Focus on Established and Emerging Allergens — *J Am Acad Dermatol* (2026)
- [PMID: 42246099] Determination of 16 organic ultraviolet absorbers in drinking water by solid phase extraction-ultra-high performance liquid chromatography-tandem mass spectrometry — *Se Pu* (2026)
- [PMID: 42197211] Organic Sunscreens-Biological Activity from an Enzymatic Perspective — *Molecules* (2026)
- [PMID: 42173181] Age-dependent modulation of CYP450 and MXR activity and physiological trade-offs in Daphnia magna exposed to organic UV filters — *Comp Biochem Physiol C Toxicol Pharmacol* (2026)
- [PMID: 42067042] Pending Food and Drug Administration approval of bemotrizinol: A potential turning point for United States sunscreen formulation — *J Am Acad Dermatol* (2026)
- [PMID: 42000182] Multi-matrix assessment of organic UV-filters in a major freshwater recreational ecosystem in Central Europe: Spatio-temporal distribution and environmental risk assessment — *Water Res* (2026)
- [PMID: 41908471] Ultrafast Spectroscopy of Commercial Sunscreen Formulations in Thin Films and on a Skin Mimic — *ACS Omega* (2026)
- [PMID: 41697961] Screening-level exposure Models to Evaluate the direct Release of Cosmetic Ingredients (MERCI): Development and application to UV filters used in suncare products — *Integr Environ Assess Manag* (2026)