Cosmetics · Quasi-drug actives
Arbutin
アルブチン (Arubuchin)
Also known as: β-Arbutin, Hydroquinone-β-D-Glucopyranoside
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| Category | Cosmetics |
|---|---|
| INCI name | Arbutin↗ |
| Japanese labeling name | アルブチン |
| Common Japanese notations | アルブチン |
| CAS number | 497-76-7↗ |
| Origin | Plant-derived or synthetic (originally isolated from bearberry) |
| Typical functions | Quasi-drug whitening active |
| Regulatory status in Japan | Approved as a quasi-drug (医薬部外品) whitening active by Japan's 厚生労働省 (Ministry of Health, Labour and Welfare). |
Arbutin is a glycosylated form of hydroquinone, originally isolated from bearberry (Arctostaphylos uva-ursi) and other plants. As a quasi-drug whitening active in Japan, it represents one of several 厚生労働省 (Ministry of Health, Labour and Welfare)-approved options for medicated bihaku formulations. Internationally, arbutin is widely used in cosmetic skincare across the Asian beauty markets.
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Classification
Tags below link to other ingredients sharing the same attribute, so you can pivot from one ingredient to its peers.
Product applications
Functions
Regulatory tags
Common OEM product categories
Finished-product categories where Japanese OEM manufacturers commonly formulate with this ingredient.
- Medicated whitening serums and lotions
- Brightening cosmetic skincare
- Spot-care products
Ingredient profile
Arbutin is a hydroquinone β-D-glucopyranoside. The glycosylation reduces direct hydroquinone availability while preserving tyrosinase-inhibition activity in the melanin biosynthesis pathway.
Alpha-arbutin is a related but stereochemically distinct compound, offered separately in supplier catalogs.
OEM applications
In Japanese cosmetics, arbutin appears in medicated whitening lines and brightening-positioned skincare across multiple brand portfolios.
Regulatory classification in Japan
Approved as a quasi-drug whitening active by 厚生労働省 (Ministry of Health, Labour and Welfare) within defined concentration ranges.
Regulatory classification in other markets
| EU | Listed in CosIng. EU SCCS opinions on alpha-arbutin and beta-arbutin recommend specific maximum concentrations — typically 2 percent for alpha-arbutin and 7 percent for beta-arbutin in face creams. Refer to the current SCCS opinions and Cosmetics Regulation annexes for the binding values. |
|---|---|
| USA | INCI recognized. |
| China | Permitted per IECIC listings. |
| Korea | Approved as a functional cosmetic ingredient under KFDA / MFDS for brightening claims. |
Market reference formulations
Example finished products will be added after each product's current full ingredient list has been verified.
All brand names and product names referenced anywhere on this site are the property of their respective owners. Example entries are provided for informational purposes only and do not imply endorsement.
Typical OEM use levels
Formulation ranges per finished-product application. Verify against the cited source before production.
| Application | Typical range | Regulatory limit | Notes |
|---|---|---|---|
| Quasi-drug whitening serum / lotion (Japan) | 3–7% | Capped per 厚生労働省 quasi-drug notification per product | β-arbutin formulations; check the brand's individual 厚生労働省 dossier(厚生労働省 医薬部外品有効成分通知 / SCCS (欧州消費者安全科学委員会) opinion on β-arbutin) |
| Cosmetic brightening serum (overseas) | 1–5% | — | EU SCCS (欧州消費者安全科学委員会) recommends ≤7% in face creams for β-arbutin(EU SCCS (欧州消費者安全科学委員会)/1642/22 (β-arbutin)) |
Stability & compatibility
- pH range
- pH 4.5–7.0
- Temperature
- Hydrolyzes to hydroquinone above ~50°C and at very low pH; cool process recommended
- Incompatibilities
- Strong acids
- Strong oxidizers
- Iron / copper ions
Add at the cool-down phase (<40°C). Use chelators (EDTA / phytate) to minimize metal-catalyzed degradation.
Storage requirements
How the receiving OEM facility needs to handle inbound raw material.
- Temperature
- Cool, dark; ≤25°C; refrigerated long-term storage extends shelf life
- Conditions
- Sealed against humidity; opaque or amber containers (light-sensitive)
- Shelf life
- 24 months sealed; reduces under heat or humid exposure
Supplier safety data + EU SCCS (欧州消費者安全科学委員会) opinion stability discussion
Supply concentration
Where this ingredient comes from — useful for single-source-risk planning.
- Primary regions
- Synthetic / fermentation-derived; no Japanese geographic concentration
- Import dependence
- Production split between Japanese, Korean, and Chinese chemical / fermentation suppliers
Beta-arbutin (Japan quasi-drug) and alpha-arbutin (cosmetic-only) sourced from different suppliers
Certifications commonly available
Certification schemes commonly obtainable for this raw material. Always confirm the specific supplier's current certificate before contracting.
| Scheme | Availability | |
|---|---|---|
| GMP (cosmetic / quasi-drug) | Standard | Required for 厚生労働省 quasi-drug supply |
| Halal | On-request | Synthetic / fermentation-derived; Halal cert available from select suppliers |
| Kosher | On-request | |
| Vegan | Common | Synthetic / non-animal origin |
| COSMOS | Rare | COSMOS-Approved synthetic-origin arbutin is limited |
Alternative ingredients
Related ingredients commonly evaluated as substitutes.
Quick answers
- What is Arbutin?
- Arbutin is a glycosylated form of hydroquinone, originally isolated from bearberry (Arctostaphylos uva-ursi) and other plants. As a quasi-drug whitening active in Japan, it represents one of several 厚生労働省 (Ministry of Health, Labour and Welfare)-approved options for medicated bihaku formulations. Internationally, arbutin is widely used in cosmetic skincare across the Asian beauty markets.
- What is the regulatory status of Arbutin in Japan?
- Approved as a quasi-drug (医薬部外品) whitening active by Japan's 厚生労働省 (Ministry of Health, Labour and Welfare).
- What products typically use Arbutin?
- Medicated whitening serums and lotions / Brightening cosmetic skincare / Spot-care products
- Where does Arbutin come from?
- Plant-derived or synthetic (originally isolated from bearberry)
- What is the INCI / JSCI labeling name for Arbutin?
- INCI: Arbutin / JSCI: アルブチン
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From the same origin
Other ingredients that share an origin classification.
Regulatory guidance
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FAQ for OEM buyers
Q. What is the difference between alpha-arbutin and beta-arbutin for OEM?
Alpha-arbutin and beta-arbutin are stereoisomers; alpha-arbutin is more stable and reportedly more potent in tyrosinase inhibition, while beta-arbutin is the form historically used in Japanese quasi-drug whitening. Specify the isomer on every CoA.
Sources · Last reviewed: 2026-04-26
- PubChem CID 440936 (alpha-arbutin), CID 6036 (arbutin/beta) — structural reference
Q. Is arbutin approved as a quasi-drug whitening active in Japan?
Yes — arbutin (beta form) is on the 厚生労働省 (Ministry of Health, Labour and Welfare) quasi-drug whitening active ingredient list; finished whitening products must be filed as quasi-drugs.
Sources · Last reviewed: 2026-04-26
- 厚生労働省 (Ministry of Health, Labour and Welfare) — quasi-drug whitening actives
Q. What is the EU regulatory status?
The EU SCCS issued opinions concluding alpha-arbutin is safe up to 2% in face creams and 0.5% in body lotions, and beta-arbutin up to 7% in face creams, with hydroquinone impurity limits applying. Confirm hydroquinone residual on supplier CoA.
Sources · Last reviewed: 2026-04-26
- SCCS Opinion on Alpha-Arbutin (SCCS/1552/15)
- SCCS Opinion on Beta-Arbutin (SCCS/1550/15)
Q. What stability challenges should I plan for?
Arbutin can hydrolyze to hydroquinone under low pH or high temperature, so target pH ~5.5–7 and avoid prolonged elevated-temperature processing. Specify residual hydroquinone (typically <10 ppm) at qualification.
Sources · Last reviewed: 2026-04-26
- Industry knowledge — arbutin stability practice
Industry-knowledge claim — not yet pinned to a single primary source
Use cases
Medicated whitening lotion (薬用美白化粧水)
- Positioning
- Mainstream daily-use whitening regimen
- Typical usage level
- ~3% (Japan quasi-drug)
- Formulation notes
- Water-phase; pH 5.5–7; pair with vitamin C derivatives or tranexamic acid.
Sources
- Industry knowledge — Japanese whitening lotion formulation
Industry-knowledge claim — not yet pinned to a single primary source
Brightening serum (alpha-arbutin)
- Positioning
- Premium Asia/global brightening positioning
- Typical usage level
- 1–2% (alpha-arbutin)
- Formulation notes
- Compatible with niacinamide and HA; airless pump packaging recommended.
Sources
- Industry knowledge — alpha-arbutin serum formulation
Industry-knowledge claim — not yet pinned to a single primary source
Brightening sheet mask
- Positioning
- K-beauty / J-beauty brightening single-use mask
- Formulation notes
- Used at 1–2% in mask serum; combine with niacinamide for synergistic claim.
Sources
- Industry knowledge — Asian brightening sheet mask category
Industry-knowledge claim — not yet pinned to a single primary source
Spot-targeted concentrate
- Positioning
- Targeted hyperpigmentation serum
- Formulation notes
- Combined with kojic acid or tranexamic acid for layered tyrosinase-pathway claim.
Sources
- Industry knowledge — spot-treatment formulation
Industry-knowledge claim — not yet pinned to a single primary source
Search the academic literature
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Official regulatory databases
External links to public Japanese / international regulatory authorities. We are not affiliated.
References
- Japan 医薬品医療機器総合機構 PMDA (Pharmaceuticals and Medical Devices Agency) — quasi-drug active ingredient approval registry
- EU SCCS opinions on alpha-arbutin and beta-arbutin
Last updated: 2026-04-22. Ingredient entries are reviewed at least annually against current regulatory listings.