# SQUALANE (squalane) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/squalane
- **Standard INCI**: `SQUALANE`
- **KR MFDS Standard Name**: `스쿠알란`
- **CAS No.**: `111-01-3`
- **EC / EINECS No.**: `203-825-6`
- **Origin**: `synthetic`
- **Functions**: 모발컨디셔닝제, 피부컨디셔닝제, 에모리엔트, 재지방화제
- **Molecular Formula / MW**: `C30H62` (422.81 g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 스쿠알란 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | SQUALANE |
| US (PCPC / MoCRA INCI) | SQUALANE |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 角鲨烷 |
| JP (JCIA / MHLW QD) | スクワラン (QD: スクワラン) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `3432`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 99.8% — NMPA IECIC (2025) Entry 03331 (2025)
- **cn_iecic_max** (rinse_off): ≤ 30% — NMPA IECIC (2025) Entry 03331 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 2 – 12
- **Max Process Temp**: ≤ 90°C
- **Synergy Pairings**: CERAMIDE NP, CHOLESTEROL, RETINOL, BAKUCHIOL, ASCORBYL TETRAISOPALMITATE
- **Incompatibilities**: Fully hydrogenated saturated hydrocarbon; non-comedogenic and completely immune to lipid peroxidation (unlike unsaturated Squalene)

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: SQUALANE | CAS No.: 111-01-3 | EC No.: 203-825-6
  - Origin: SYNTHETIC | Functions: , , , 
  - Physicochemical Profile: Formula C30H62 | MW 422.81 g/mol | LogP 11.6 | Ionic Nature: non-ionic | PubChem CID 7793
  - Official Regional Label Names: US [SQUALANE] · EU [SQUALANE] · CN [角鲨烷] · JP [スクワラン] · JP Quasi-Drug [スクワラン]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - SQUALANE functions primarily as , , ,  in dermatological and cosmetic formulations. 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: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 3432 (角鲨烷))
  - No specific Annex prohibition or numeric restriction across the 6 major jurisdictions (Permitted under general GMP safety assessment).
  - Official Safety & Historical Use Concentration (Layer 2): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 99.8% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 30.0%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [emulsion_cream] Typical range: 0.5 ~ 15.0% (Median 3.0%, Ref: CIR Squalane Safety Assessment & Formulation Library) — Skin-identical sebum-mimetic barrier emollient
  - [anhydrous_balm] Typical range: 5.0 ~ 99.0% (Median 30.0%, Ref: CIR Squalane Assessment) — Non-oxidizing facial oil & balm carrier
  - [sun_color] Typical range: 5.0 ~ 13.0% (Median 5.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=5, GRANT 3 · EVONIK 1 · SEPPIC 1)) — Sun care & color cosmetics dispersion / sensory modifier
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Oil Phase (Cold or Hot Process)
  - Optimal pH Range: pH 2.0 ~ 12.0 | Max Process Temp: Max 90°C | Electrolyte Tolerance: HIGH
  - Incompatibility / Caution: Fully hydrogenated saturated hydrocarbon; non-comedogenic and completely immune to lipid peroxidation (unlike unsaturated Squalene)
  - Synergy Pairings: CERAMIDE NP, CHOLESTEROL, RETINOL, BAKUCHIOL, ASCORBYL TETRAISOPALMITATE | Reference Trade Names: Neossance™ Squalane, Phytosqualane®
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 22361190 (2012, Adv Food Nutr Res): Biological importance and applications of squalene and squalane
  - PMID 41427219 (2025, ACS Omega): Effect of Squalane as a Carrier in O/W Nanoemulsions for Dermal Delivery of Vitamin E
  - PMID 40787365 (2025, ACS Omega): From Olive Pomace to Squalane: A Green Chemistry Route Using 2‑Methyltetrahydrofuran

## 6. Linked PubMed Literature
- [PMID: 22361190] Biological importance and applications of squalene and squalane — *Adv Food Nutr Res* (2012)
- [PMID: 41427219] Effect of Squalane as a Carrier in O/W Nanoemulsions for Dermal Delivery of Vitamin E — *ACS Omega* (2025)
- [PMID: 40787365] From Olive Pomace to Squalane: A Green Chemistry Route Using 2‑Methyltetrahydrofuran — *ACS Omega* (2025)
- [PMID: 40363772] Squalane as a Promising Agent Protecting UV-Induced Inhibition of Collagen Biosynthesis and Wound Healing in Human Dermal Fibroblast — *Molecules* (2025)
- [PMID: 37752766] Squalane and Squalene — *Int J Toxicol* (2023)
- [PMID: 35994992] Effect of squalane-based emulsion on polyphenols skin penetration: Ex vivo skin study — *Colloids Surf B Biointerfaces* (2022)
- [PMID: 40722956] The Mechanism of Protective Action of Plant-Derived Squalane (2,6,10,15,19,23-Hexamethyltetracosane) Against UVA Radiation-Induced Apoptosis in Human Dermal Fibroblasts — *Antioxidants (Basel)* (2025)
- [PMID: 35648815] Reactions and Products of Squalene and Ozone: A Review — *Environ Sci Technol* (2022)
- [PMID: 39355739] Explicating the multifunctional roles of tocotrienol and squalene in promoting skin health — *Skin Health Dis* (2024)
- [PMID: 19169201] Biological and pharmacological activities of squalene and related compounds: potential uses in cosmetic dermatology — *Molecules* (2009)
- [PMID: 29328637] Alp Rose stem cells, olive oil squalene and a natural alkyl polyglucoside emulsifier: Are they appropriate ingredients of skin moisturizers - in vivo efficacy on normal and sodium lauryl sulfate - irritated skin? — *Vojnosanit Pregl* (2016)
- [PMID: 41892232] Brood-Derived Fat Extracts from Apis mellifera as Sustainable Alternatives to Beeswax in Topical Nanostructured Lipid Carriers — *Biology (Basel)* (2026)
- [PMID: 40037469] Breaking the virus: Yeast glucans as an effective alternative to acyclovir in HSVI treatment — *Eur J Pharm Biopharm* (2025)
- [PMID: 39741562] The Role of Moisturizer Containing Anti-inflammatory on Skin Hydration in Mild-Moderate Atopic Dermatitis Patients — *Dermatol Res Pract* (2024)
- [PMID: 37468272] Mechanical Properties and Friction Dynamics of Organogels Solidified with Rice Paraffin — *J Oleo Sci* (2023)
- [PMID: 37315362] Migration of polycyclic aromatic hydrocarbons from a polymer surrogate through the stratum corneum layer of the skin — *Ecotoxicol Environ Saf* (2023)
- [PMID: 37164691] A Sucrose Fatty Acid Ester-mixed Emulsifier as Stabilizer of Emulsion Systems — *J Oleo Sci* (2023)