# POLYSORBATE 20 (polysorbate-20) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/polysorbate-20
- **Standard INCI**: `POLYSORBATE 20`
- **KR MFDS Standard Name**: `폴리솔베이트20`
- **CAS No.**: `9005-64-5`
- **EC / EINECS No.**: `N/A`
- **Origin**: `synthetic`
- **Functions**: 유화제, 세정제
- **Molecular Formula / MW**: `C58H114O26` (1227.54 g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 폴리솔베이트20 |
| KR (Former Names) | 폴리소르베이트20, 폴리솔베이트 20 |
| EU (CosIng 1223/2009) | POLYSORBATE 20 |
| US (PCPC / MoCRA INCI) | POLYSORBATE 20 |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 聚山梨醇酯-20 |
| JP (JCIA / MHLW QD) | ポリソルベート２０ (QD: ポリオキシエチレンソルビタンモノラウレート（２０Ｅ．Ｏ．）) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `3978`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 15% — NMPA IECIC (2025) Entry 03645 (2025)
- **cn_iecic_max** (rinse_off): ≤ 10% — NMPA IECIC (2025) Entry 03645 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 3.5 – 9
- **Max Process Temp**: ≤ 80°C
- **Synergy Pairings**: PHENOXYETHANOL, FRAGRANCE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
- **Incompatibilities**: High concentrations (>2%) can partition lipophilic preservatives (parabens, phenoxyethanol) into micelles, reducing antimicrobial efficacy

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: POLYSORBATE 20 | CAS No.: 9005-64-5 | EC No.: N/A
  - Origin: SYNTHETIC | Functions: , 
  - Physicochemical Profile: Formula C58H114O26 | MW 1227.54 g/mol | /   | Ionic Nature: non-ionic | PubChem CID 443314
  - Official Regional Label Names: US [POLYSORBATE 20] · EU [POLYSORBATE 20] · CN [聚山梨醇酯-20] · JP [ポリソルベート２０] · JP Quasi-Drug [ポリオキシエチレンソルビタンモノラウレート（２０Ｅ．Ｏ．）]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Sorbitan, monododecanoate, poly(oxy-1,2-ethanediyl) derivs. 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. 3978 (聚山梨醇酯-20))
  - 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 15.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 10.0%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [aqueous_serum] Typical range: 0.2 ~ 3.0% (Median 0.8%, Ref: SEPPIC MONTANOX 20 TDS & CIR Polysorbates Assessment) — Standard high-HLB non-ionic aqueous solubilizer
  - [emulsion_cream] Typical range: 0.1 ~ 3.0% (Median 0.75%, Ref: Global Starter Formulation Library Statistical Distribution (n=27, GRANT 14 · SEPPIC 10 · EVONIK 3)) — Emulsion cream & lotion structural / conditioning agent
  - [sun_color] Typical range: 0.1 ~ 1.0% (Median 0.2%, Ref: Global Starter Formulation Library Statistical Distribution (n=14, GRANT 13 · SEPPIC 1)) — Sun care & color cosmetics dispersion / sensory modifier
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Pre-mix with lipophilic fragrance/oil (3:1~5:1) before adding to Water Phase
  - Optimal pH Range: pH 3.5 ~ 9.0 | Max Process Temp: Max 80°C | Electrolyte Tolerance: HIGH
  - Incompatibility / Caution: High concentrations (>2%) can partition lipophilic preservatives (parabens, phenoxyethanol) into micelles, reducing antimicrobial efficacy
  - Synergy Pairings: PHENOXYETHANOL, FRAGRANCE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL | Reference Trade Names: Tween™ 20, MONTANOX™ 20, Kotilen-20
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 40753466 (2025, Cancer): Intratumoral vidutolimod as monotherapy or in combination with pembrolizumab in patients with programmed cell death 1 bl
  - PMID 39596238 (2024, Int J Mol Sci): Nanotechnology-Driven Delivery of Caffeine Using Ultradeformable Liposomes-Coated Hollow Mesoporous Silica Nanoparticles
  - PMID 37357890 (2023, Pharm Dev Technol): Development of invaethosomes and invaflexosomes for dermal delivery of clotrimazole: optimization, characterization and 

## 6. Linked PubMed Literature
- [PMID: 40753466] Intratumoral vidutolimod as monotherapy or in combination with pembrolizumab in patients with programmed cell death 1 blockade-resistant melanoma: Final analysis from a phase 1b study — *Cancer* (2025)
- [PMID: 39596238] Nanotechnology-Driven Delivery of Caffeine Using Ultradeformable Liposomes-Coated Hollow Mesoporous Silica Nanoparticles for Enhanced Follicular Delivery and Treatment of Androgenetic Alopecia — *Int J Mol Sci* (2024)
- [PMID: 37357890] Development of invaethosomes and invaflexosomes for dermal delivery of clotrimazole: optimization, characterization and antifungal activity — *Pharm Dev Technol* (2023)
- [PMID: 36725035] Allergy to Omalizumab: Lessons from a Reaction to the Coronavirus 2019 Vaccine — *Intern Med* (2023)
- [PMID: 41441633] Immunological Considerations of Polysorbate as an Excipient in Botulinum Neurotoxin Type A Formulations: A Narrative Review — *Toxins (Basel)* (2025)
- [PMID: 40925494] Unravelling the polysorbate 20 composition: A fusion of UPLC-MS analysis and stochastic modelling — *Eur J Pharm Biopharm* (2025)
- [PMID: 39533516] Micellar solubility and co-solubilization of fragrance raw materials in sodium dodecyl sulfate and polysorbate 20 surfactant systems — *Int J Cosmet Sci* (2025)
- [PMID: 38794319] Surfactants' Interplay with Biofilm Development in Staphylococcus and Candida — *Pharmaceutics* (2024)
- [PMID: 37630195] Molluscicidal and Cercaricidal Effects of Myrciaria floribunda Essential Oil Nanoemulsion — *Molecules* (2023)
- [PMID: 37492533] The effect of polysorbate 20 and polysorbate 80 on the solubility of quercetin — *J Public Health Afr* (2023)
- [PMID: 36425678] Synthesis and characterization of a lactose-based biosurfactant by a novel nanodendritic catalyst and evaluating its efficacy as an emulsifier in a food emulsion system — *RSC Adv* (2022)
- [PMID: 34449810] Safety verification for polysorbate 20, pharmaceutical excipient for intramuscular administration, in Sprague-Dawley rats and New Zealand White rabbits — *PLoS One* (2021)