# TOCOPHERYL ACETATE (tocopheryl-acetate) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/tocopheryl-acetate
- **Standard INCI**: `TOCOPHERYL ACETATE`
- **KR MFDS Standard Name**: `토코페릴아세테이트`
- **CAS No.**: `7695-91-2`
- **EC / EINECS No.**: `231-710-0`
- **Origin**: `vitamin`
- **Functions**: 항산화제, 피부컨디셔닝제
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 토코페릴아세테이트 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | TOCOPHERYL ACETATE |
| US (PCPC / MoCRA INCI) | TOCOPHERYL ACETATE |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 生育酚乙酸酯 |
| JP (JCIA / MHLW QD) | 酢酸トコフェロール (QD: 酢酸ｄｌ－α－トコフェロール) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `6043`)
- **JP (MHLW)**: `restricted`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 36% — NMPA IECIC (2025) Entry 05895 (2025)
- **cn_iecic_max** (rinse_off): ≤ 5% — NMPA IECIC (2025) Entry 05895 (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: TOCOPHERYL ACETATE | CAS No.: 7695-91-2 | EC No.: 231-710-0
  - Origin: VITAMIN | Functions: , 
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: non-ionic | CosIng/MFDS 
  - Official Regional Label Names: US [TOCOPHERYL ACETATE] · EU [TOCOPHERYL ACETATE] · CN [生育酚乙酸酯] · JP [酢酸トコフェロール] · JP Quasi-Drug [酢酸ｄｌ－α－トコフェロール]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - TOCOPHERYL ACETATE functions primarily as ,  in dermatological and cosmetic formulations. 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: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: RESTRICTED | ASEAN: NONE (CN IECIC (2025) Entry No. 6043 (生育酚乙酸酯))
  - [JP / COMPOSITION / limited] (Max 3.03%): 
  - Official Safety & Historical Use Concentration (Layer 2): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 36.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 5.0%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [anhydrous_balm] Typical range: 0.1 ~ 1.0% (Median 0.5%, Ref: Global Starter Formulation Library Statistical Distribution (n=8, EVONIK 4 · GRANT 4)) — Anhydrous balm, oil & stick structural emollient
  - [aqueous_serum] Typical range: 0.1 ~ 1.0% (Median 0.2%, Ref: Global Starter Formulation Library Statistical Distribution (n=15, GRANT 13 · SEPPIC 2)) — Aqueous serum, toner & hydrogel matrix formulation component
  - [cleanser_rinse] Typical range: 0.1 ~ 0.35% (Median 0.2%, Ref: Global Starter Formulation Library Statistical Distribution (n=9, GRANT 5 · EVONIK 3 · SEPPIC 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: TOCOPHERYL ACETATE
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 12537931 (2002, Int J Toxicol): Final report on the safety assessment of Tocopherol, Tocopheryl Acetate, Tocopheryl Linoleate, Tocopheryl Linoleate/Olea
  - PMID 5723132 (1968, J Vitaminol (Kyoto)): Percutaneous absorption of alpha-tocopheryl acetate
  - PMID 8506388 (1993, Photochem Photobiol): Uptake and bioconversion of alpha-tocopheryl acetate to alpha-tocopherol in skin of hairless mice

## 6. Linked PubMed Literature
- [PMID: 12537931] Final report on the safety assessment of Tocopherol, Tocopheryl Acetate, Tocopheryl Linoleate, Tocopheryl Linoleate/Oleate, Tocopheryl Nicotinate, Tocopheryl Succinate, Dioleyl Tocopheryl Methylsilanol, Potassium Ascorbyl Tocopheryl Phosphate, and Tocophersolan — *Int J Toxicol* (2002)
- [PMID: 5723132] Percutaneous absorption of alpha-tocopheryl acetate — *J Vitaminol (Kyoto)* (1968)
- [PMID: 8506388] Uptake and bioconversion of alpha-tocopheryl acetate to alpha-tocopherol in skin of hairless mice — *Photochem Photobiol* (1993)
- [PMID: 41981221] TPGS Modified Phospholipid-free and Cholesterol-free Ethosomes Enhance Chemical Stability and Transdermal Permeation Of Retinol — *AAPS PharmSciTech* (2026)
- [PMID: 41309687] Nanostructured Lipid Carrier Based Gel Containing α-Tocopherol and α-Tocopheryl Acetate for Synergistic Cutaneous Antiaging Efficacy — *Sci Rep* (2025)
- [PMID: 40196947] Effects of a Moisturizer Containing Colloidal Oatmeal and Filaggrin Technology on Staphylococcus Species In Vitro — *J Drugs Dermatol* (2025)
- [PMID: 39330197] Unraveling the Impact of the Oil Phase on the Physicochemical Stability and Skin Permeability of Melatonin Gel Formulations — *Gels* (2024)
- [PMID: 37539504] Topical treatment of anal condylomata with Propionibacterium acnes lysate: results of a multicentric observational study — *Ital J Dermatol Venerol* (2023)
- [PMID: 34471722] Safety assessment on comedogenicity of dermatological products containing d-alpha tocopheryl acetate in Asian subjects: A double-blind randomized controlled trial — *Contemp Clin Trials Commun* (2021)
- [PMID: 24004959] Tocopheryl acetate 20% spray for elimination of head louse infestation: a randomised controlled trial comparing with 1% permethrin creme rinse — *BMC Pharmacol Toxicol* (2013)
- [PMID: 4996747] Isomers of alpha-tocopheryl acetate and their biological activity — *Lipids* (1971)
- [PMID: 4999545] Isomers of alpha-tocopheryl acetate and their biological activity — *Lipids* (1971)
- [PMID: 1429281] Effect of long- or short-term feeding of alpha-tocopheryl acetate to Holstein and crossbred beef steers on performance, carcass characteristics, and beef color stability — *J Anim Sci* (1992)
- [PMID: 40631809] Efficacy of a topical polyphenol-based formulation in palmoplantar psoriasis: an observational study — *Dermatol Reports* (2026)
- [PMID: 38556283] Topical Nanoemulsion Hydrogel Formulated from Supercritical Fluid Extracted Palm-Pressed Fiber Oil and Virgin Coconut Oil with Antioxidant and Antibacterial Effects — *J Oleo Sci* (2024)
- [PMID: 37153953] Failure of head lice treatment with tocopheryl acetate spray: results of a sponsor-free clinical study — *Ital J Dermatol Venerol* (2023)
- [PMID: 35437850] Darier disease successfully treated with a topical agent containing vitamin A (retinyl palmitate), vitamin E, and urea — *J Dermatol* (2022)
- [PMID: 34900006] Assessment of a feed additive consisting of all-rac-alpha-tocopheryl acetate (vitamin E) for all animal species for the renewal of its authorisation (Jilin Beisha Pharmaceutical Co., Ltd) — *EFSA J* (2021)
- [PMID: 34884343] A Clinical Study on the Efficacy and Tolerability of a New Topical Gel and Toothpaste in Patients with Xerostomia: A Randomized Controlled Trial — *J Clin Med* (2021)
