# POLYSORBATE 80 (polysorbate-80) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/polysorbate-80
- **Standard INCI**: `POLYSORBATE 80`
- **KR MFDS Standard Name**: `폴리솔베이트80`
- **CAS No.**: `9005-65-6`
- **EC / EINECS No.**: `N/A`
- **Origin**: `synthetic`
- **Functions**: 변성제, 유화제, 세정제
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 폴리솔베이트80 |
| KR (Former Names) | 폴리소르베이트80 |
| EU (CosIng 1223/2009) | POLYSORBATE 80 |
| US (PCPC / MoCRA INCI) | POLYSORBATE 80 |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 聚山梨醇酯-80 |
| JP (JCIA / MHLW QD) | ポリソルベート８０ (QD: モノオレイン酸ポリオキシエチレンソルビタン（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: `3984`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 10% — NMPA IECIC (2025) Entry 03648 (2025)
- **cn_iecic_max** (rinse_off): ≤ 8% — NMPA IECIC (2025) Entry 03648 (2025)

## 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: POLYSORBATE 80 | CAS No.: 9005-65-6 | EC No.: N/A
  - Origin: SYNTHETIC | Functions: , , 
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: non-ionic | CosIng/MFDS 
  - Official Regional Label Names: US [POLYSORBATE 80] · EU [POLYSORBATE 80] · CN [聚山梨醇酯-80] · JP [ポリソルベート８０] · JP Quasi-Drug [モノオレイン酸ポリオキシエチレンソルビタン（２０Ｅ．Ｏ．）]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Sorbitan, mono-9-octadecenoate, poly(oxy-1,2-ethanediyl) derivs., (Z)- 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. 3984 (聚山梨醇酯-80))
  - 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 10.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 8.0%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [emulsion_cream] Typical range: 0.3 ~ 5.0% (Median 1.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=7, SEPPIC 4 · EVONIK 2 · GRANT 1)) — Emulsion cream & lotion structural / conditioning agent
■ [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: POLYSORBATE 80
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 41420580 (2025, Rev Alerg Mex): Sensitization to polyethylene glycol and polysorbate in allergic patients with systemic adverse reactions following COVI
  - PMID 41349376 (2026, Colloids Surf B Biointerfaces): Sustainable encapsulation of lipophilic fragrances using biodegradable sodium alginate for cosmetic applications
  - PMID 41092173 (2025, Braz J Biol): Preparation of nanoemulsions containing herbal derivatives: a dynamic light scattering analysis

## 6. Linked PubMed Literature
- [PMID: 41420580] Sensitization to polyethylene glycol and polysorbate in allergic patients with systemic adverse reactions following COVID-19 vaccination — *Rev Alerg Mex* (2025)
- [PMID: 41349376] Sustainable encapsulation of lipophilic fragrances using biodegradable sodium alginate for cosmetic applications — *Colloids Surf B Biointerfaces* (2026)
- [PMID: 41092173] Preparation of nanoemulsions containing herbal derivatives: a dynamic light scattering analysis — *Braz J Biol* (2025)
- [PMID: 40998087] Effects of common cosmetic ingredients on growth of dominant human skin inhabitant Cutibacterium acnes — *Anaerobe* (2025)
- [PMID: 40836720] Evaluation for the Risk of Allergy to COVID-19 Vaccines in People with History of Allergy Diathesis — *J Assoc Physicians India* (2025)
- [PMID: 40821660] Gramicidin and chlorhexidine encapsulated in bicontinuous microemulsions: antimicrobial activity performance and their impact on self-assembly — *J Surfactants Deterg* (2025)
- [PMID: 39942728] Design of Decanoic Acid/Polysorbate 80 Composite Vesicles as Cosmetics Carrier: Stability, Skin Permeability, Antioxidant and Antibacterial Activity — *Molecules* (2025)
- [PMID: 42046683] Design, optimization, and in vitro antimicrobial evaluation of a clove leaf oil nanoemulsion against bovine mastitis-associated pathogens — *Vet World* (2026)
- [PMID: 41441633] Immunological Considerations of Polysorbate as an Excipient in Botulinum Neurotoxin Type A Formulations: A Narrative Review — *Toxins (Basel)* (2025)
- [PMID: 41247535] Cymbopogon citratus essential oil infused zinc oxide nanoparticles for eco-friendly anticariogenic action — *Clin Oral Investig* (2025)
- [PMID: 40988838] Taming the Rash: A Dermatological Case Report on Effective Treatments for Refractory Folliculitis — *Cureus* (2025)
- [PMID: 40761579] Evaluating vaccination dosing strategies for SARS-CoV-2 in patients at high-risk for allergic reactions: Insights from vaccination campaign — *World Allergy Organ J* (2025)