# ALPHA-ARBUTIN (alpha-arbutin) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/alpha-arbutin
- **Standard INCI**: `ALPHA-ARBUTIN`
- **KR MFDS Standard Name**: `알파-알부틴`
- **CAS No.**: `84380-01-8`
- **EC / EINECS No.**: `617-561-8`
- **Origin**: `synthetic`
- **Functions**: 항산화제, 미백제, 탈색제, 피부컨디셔닝제
- **Molecular Formula / MW**: `C12H16O7` (272.25 g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 알파-알부틴 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | ALPHA-ARBUTIN |
| US (PCPC / MoCRA INCI) | ALPHA-ARBUTIN |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | α-熊果苷 |
| JP (JCIA / MHLW QD) | α－アルブチン (QD: α－アルブチン) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `noted`
- **EU (1223/2009)**: `restricted`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `noted` (Entry: `1005`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `restricted`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **sccs_opinion** (face_cream): ≤ 2% — undefined (undefined)
- **sccs_opinion** (face_cream): ≤ 2% — undefined (undefined)
- **sccs_opinion** (body_lotion): ≤ 0.5% — undefined (undefined)
- **cn_iecic_max** (leave_on): ≤ 2% — NMPA IECIC (2025) Entry 00048 (2025)
- **cn_iecic_max** (rinse_off): ≤ 2% — NMPA IECIC (2025) Entry 00048 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 4.5 – 6
- **Max Process Temp**: ≤ 55°C
- **Synergy Pairings**: NIACINAMIDE, TRANEXAMIC ACID, SODIUM METABISULFITE, DISODIUM EDTA, 3-O-ETHYL ASCORBIC ACID
- **Incompatibilities**: CRITICAL INCOMPATIBILITY: Hydrolyzes into banned toxic Hydroquinone at pH < 3.5, pH > 7.0, or elevated temperatures, causing brown discoloration! Must buffer strictly to pH 4.8~5.8 and stabilize with 0.02~0.05% Sodium Metabisulfite + Disodium EDTA

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: ALPHA-ARBUTIN | CAS No.: 84380-01-8 | EC No.: 617-561-8
  - Origin: SYNTHETIC | Functions: , , , 
  - Physicochemical Profile: Formula C12H16O7 | MW 272.25 g/mol | LogP -1.35 | Ionic Nature: non-ionic | PubChem CID 158637
  - Official Regional Label Names: US [ALPHA-ARBUTIN] · EU [ALPHA-ARBUTIN] · CN [α-熊果苷] · JP [α－アルブチン] · JP Quasi-Drug [α－アルブチン]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Biosynthetic alpha-glucoside of hydroquinone that functions as a highly specific competitive inhibitor of human tyrosinase with ~10-fold greater potency than beta-arbutin. Suppresses epidermal melanin synthesis without melanocyte cytotoxicity.
■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)]
  - Regional Summary: KR: NOTED | EU: RESTRICTED | US: NONE | CN: NOTED | JP: NONE | ASEAN: RESTRICTED (CN IECIC (2025) Entry No. 1005 (α-熊果苷))
  - [EU / COMPOSITION / limited] (Max 0.5%): 
  - [KR / COMPOSITION / noted]: 
  - [CN / COMPOSITION / noted]: 
  - [EU / OFFICIAL / restricted] (Max 2.0%): EU Regulation (EU) 2024/996 (Annex III): Max 2.0% in face creams, Max 0.5% in body lotions. Hydroquinone levels shall remain as low as possi
  - Official Safety & Historical Use Concentration (Layer 2): sccs (sccs_opinion, face_cream): Max 2% / sccs (sccs_opinion, face_cream): Max 2% / sccs (sccs_opinion, body_lotion): Max 0.5%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [aqueous_serum] Typical range: 0.2 ~ 2.0% (Median 1.0%, Ref: EU SCCS/1642/22 Final Opinion & EU Omnibus 2024/996) — Competitive tyrosinase inhibitor for skin brightening (EU face max 2.0%)
  - [emulsion_cream] Typical range: 0.2 ~ 2.0% (Median 1.0%, Ref: EU Regulation 2024/996 Annex III & SCCS/1642/22) — Brightening face cream (Max 2.0%) & body lotion (Max 0.5% in EU)
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Cool-down Phase (< 50°C; Must buffer pH to 4.5~6.0)
  - Optimal pH Range: pH 4.5 ~ 6.0 | Max Process Temp: Max 55°C | Electrolyte Tolerance: HIGH
  - Incompatibility / Caution: CRITICAL INCOMPATIBILITY: Hydrolyzes into banned toxic Hydroquinone at pH < 3.5, pH > 7.0, or elevated temperatures, causing brown discoloration! Must buffer strictly to pH 4.8~5.8 and stabilize with 0.02~0.05% Sodium Metabisulfite + Disodium EDTA
  - Synergy Pairings: NIACINAMIDE, TRANEXAMIC ACID, SODIUM METABISULFITE, DISODIUM EDTA, 3-O-ETHYL ASCORBIC ACID | Reference Trade Names: Alpha-Arbutin (DSM / Pentapharm)
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 40705370 (2025, Drug Dev Ind Pharm): Quantifying alpha arbutin and niacinamide from nanocosmeceutical formulation matrix: AQbD driven high-performance thin-l
  - PMID 41346234 (2025, Nat Prod Res): Chemical composition and ameliorative effect of Cinnamomum burmanni (Nees & T.Nees) Blume essential oil nanoemulgel in U
  - PMID 42281907 (2026, JPRAS Open): Chitosan in aesthetic practice: A clinical narrative review of skin, scar, and scalp applications

## 6. Linked PubMed Literature
- [PMID: 40705370] Quantifying alpha arbutin and niacinamide from nanocosmeceutical formulation matrix: AQbD driven high-performance thin-layer chromatographic method — *Drug Dev Ind Pharm* (2025)
- [PMID: 41346234] Chemical composition and ameliorative effect of Cinnamomum burmanni (Nees & T.Nees) Blume essential oil nanoemulgel in UVB-induced skin photoaging C57BL/6 mice: in vivo and in silico studies — *Nat Prod Res* (2025)
- [PMID: 42281907] Chitosan in aesthetic practice: A clinical narrative review of skin, scar, and scalp applications — *JPRAS Open* (2026)
- [PMID: 42253203] A New Ultrasonic-Assisted One-Step Synthesis of Skin Lightening Bioactive Molecules by Using Fe/SiO2 as a Catalyst — *Curr Org Synth* (2026)
- [PMID: 42173470] Toxicological evaluation of α-Arbutin, a skin depigmenting agent, with emphasis on mutagenicity assessment — *Food Chem Toxicol* (2026)
- [PMID: 41657122] Cosmetic potential of Ganoderma lucidum (Reishi) extract in a topical cream formulation — *Int J Cosmet Sci* (2026)
- [PMID: 41518652] Antioxidant, anti-melanogenic, anti-inflammatory, and cytotoxic constituents of Butea monosperma (Lam.) Kuntze flowers — *Nat Prod Res* (2026)
- [PMID: 41147757] Insight Into the Cellular Activities of Tranexamic Acid as an Option for Melasma Treatment — *Cell Biol Int* (2026)
- [PMID: 40841180] Tetrahedral Framework Nucleic Acids as Thermal Loading Nanocarriers for Enhanced Inhibition of Melanin Synthesis — *ACS Appl Mater Interfaces* (2025)
- [PMID: 40443353] Acute and Subacute Toxicity Study of α-Arbutin: An In Vivo Evidence — *J Appl Toxicol* (2025)
- [PMID: 39943675] Efficacy and Safety of a Topical Formulation Containing Trihydroxybenzoic Acid Glucoside and α-Arbutin, Applied Along With a Sunscreen: A Noncomparative, Prospective, Interventional Study in Indian Females With Facial Melasma or Dark Spots — *J Cosmet Dermatol* (2025)
- [PMID: 39860181] Cuphea hookeriana: Phytochemical Profile and the Cosmeceutical and Dermatological Properties of Its Active Fraction from the Whole Plant — *Molecules* (2025)