# TOCOPHEROL (tocopherol) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/tocopherol
- **Standard INCI**: `TOCOPHEROL`
- **KR MFDS Standard Name**: `토코페롤`
- **CAS No.**: `54-28-4`
- **EC / EINECS No.**: `200-201-5`
- **Origin**: `vitamin`
- **Functions**: 항산화제, 향료, 피부컨디셔닝제, 밀폐제
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 토코페롤 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | TOCOPHEROL |
| US (PCPC / MoCRA INCI) | TOCOPHEROL |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 生育酚(维生素E) |
| JP (JCIA / MHLW QD) | トコフェロール (QD: 天然ビタミンＥ) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `restricted`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `6029`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`

- **KR** [limited]: ≤ 20% —  (화장품 안전기준 등에 관한 규정 [별표2] 사용상의 제한이 필요한 원료)

## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 5% — NMPA IECIC (2025) Entry 05892 (2025)
- **cn_iecic_max** (rinse_off): ≤ 3% — NMPA IECIC (2025) Entry 05892 (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: TOCOPHEROL | CAS No.: 54-28-4 | EC No.: 200-201-5
  - Origin: VITAMIN | Functions: , , , 
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: non-ionic | CosIng/MFDS 
  - Official Regional Label Names: US [TOCOPHEROL] · EU [TOCOPHEROL] · CN [生育酚(维生素E)] · JP [トコフェロール] · JP Quasi-Drug [天然ビタミンＥ]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Tocopherol consists of alpha-tocopherol, beta-tocopherol, delta-tocopherol and/or gamma-tocopherol and conforms to the formulae: Classified under origin 'vitamin', 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: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 6029 (生育酚(维生素E)))
  - [KR / COMPOSITION / limited] (Max 20%): 
  - Official Safety & Historical Use Concentration (Layer 2): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 5.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 3.0%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [anhydrous_balm] Typical range: 0.05 ~ 4.0% (Median 0.5%, Ref: Global Starter Formulation Library Statistical Distribution (n=10, SEPPIC 7 · GRANT 2 · EVONIK 1)) — Anhydrous balm, oil & stick structural emollient
  - [aqueous_serum] Typical range: 0.05 ~ 1.0% (Median 1.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=15, GRANT 8 · SEPPIC 6 · EVONIK 1)) — Aqueous serum, toner & hydrogel matrix formulation component
  - [cleanser_rinse] Typical range: 0.05 ~ 7.0% (Median 0.5%, Ref: Global Starter Formulation Library Statistical Distribution (n=7, SEPPIC 6 · EVONIK 1)) — Rinse-off cleanser & surfactant system 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: TOCOPHEROL
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 31975502 (2020, J Cosmet Dermatol): Anti-aging and brightening effects of a topical treatment containing vitamin C, vitamin E, and raspberry leaf cell cultu
  - PMID 41690654 (2026, Clin Dermatol): Vitamin E in dermatology
  - PMID 34655146 (2021, Dermatol Ther): Vitamin E supplementation in inflammatory skin diseases

## 6. Linked PubMed Literature
- [PMID: 31975502] Anti-aging and brightening effects of a topical treatment containing vitamin C, vitamin E, and raspberry leaf cell culture extract: A split-face, randomized controlled trial — *J Cosmet Dermatol* (2020)
- [PMID: 41690654] Vitamin E in dermatology — *Clin Dermatol* (2026)
- [PMID: 34655146] Vitamin E supplementation in inflammatory skin diseases — *Dermatol Ther* (2021)
- [PMID: 17628183] Vitamin E and mast cells — *Vitam Horm* (2007)
- [PMID: 20487657] Vitamin E and allergic contact dermatitis — *Dermatitis* (2010)
- [PMID: 33324057] Pharmacology and Pharmacokinetics of Vitamin E: Nanoformulations to Enhance Bioavailability — *Int J Nanomedicine* (2020)
- [PMID: 42235198] Multifunctional self-assembled nanoparticles loaded into immunomodulatory microneedles for synergistic therapy of psoriasis — *Colloids Surf B Biointerfaces* (2026)
- [PMID: 42223799] Enhancing skin moisture and anti-aging by DL-α-tocopherol loading sodium alginate-based hydrogel microneedles — *Drug Deliv Transl Res* (2026)
- [PMID: 42030024] Screening of microalgal strains with elevated α-tocopherol levels and antioxidant capacity for biotechnological applications — *Arch Microbiol* (2026)
- [PMID: 41976115] A Self-Deliverable H(2)O(2)-Responsive Tocopherol Dimer for Enhanced Antioxidant and Liposomal Delivery — *Molecules* (2026)
- [PMID: 42281344] Exploring the role of alpha-tocopherol in pain and inflammation: interplay with TRPV1, PKA, and PKC pathways — *Korean J Pain* (2026)
- [PMID: 42195887] Storage Quality and Tocopherol Content of Crude Glandless Cottonseed Oil Under Accelerated Oxidation Conditions in Comparison with Commercial Cottonseed Oil — *Foods* (2026)
- [PMID: 42274816] Algal Derived Bioactive Compounds as Radiation Protectant: An Emerging Strategy for Future Applications — *Curr Microbiol* (2026)
- [PMID: 42255700] Safflower (Carthamus tinctorius L.) Seed Oils: Effect of Extraction Process and Cultivars on Chemical Composition, Physicochemical Parameters and Nutritional Quality Index — *Food Sci Nutr* (2026)
- [PMID: 42048920] Meat oxidative stability in lambs given almond skin to partially replace maize — *Meat Sci* (2026)
- [PMID: 42048793] Astaxanthin-ascorbyl palmitate co-loaded transfersomes: Targeting oxidative stress and inflammation — *Colloids Surf B Biointerfaces* (2026)
- [PMID: 42035878] Chemical Composition and Time-Temperature Arrhenius Modeling for Shelf-Life Prediction of Olive Flounder (Paralichthys olivaceus) By-Products — *J Food Prot* (2026)
- [PMID: 41963430] New insights into the chemical composition and biological activities of Lawsonia inermis seeds and leaves: a comparative study — *Sci Rep* (2026)