Cosmetics · Quasi-drug actives
Tranexamic Acid
トラネキサム酸 (Toranekisamu-san)
Also known as: TXA
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| Category | Cosmetics |
|---|---|
| INCI name | Tranexamic Acid↗ |
| Japanese labeling name | トラネキサム酸 |
| Common Japanese notations | トラネキサム酸 |
| CAS number | 1197-18-8↗ |
| Origin | Synthetic (developed in Japan) |
| Typical functions | Quasi-drug whitening active (cosmetic context), Pharmaceutical use (separate context, antifibrinolytic) |
| Regulatory status in Japan | Approved as a quasi-drug (医薬部外品) whitening active by 厚生労働省 (Ministry of Health, Labour and Welfare). Pharmaceutical use is regulated separately. |
Tranexamic acid is a synthetic lysine analog originally developed in 1962 by Shosuke and Utako Okamoto at Keio University in Japan as an antifibrinolytic pharmaceutical. In cosmetic use, the compound is approved as a quasi-drug whitening active in Japan, where it is positioned around interrupting inflammation-related contributors to hyperpigmentation. The pharmaceutical use and cosmetic use are entirely separately regulated.
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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
Regulatory tags
Origin
Common OEM product categories
Finished-product categories where Japanese OEM manufacturers commonly formulate with this ingredient.
- Medicated whitening products (薬用美白)
- Spot-care treatment products
- Pharmaceutical applications (separate context)
Ingredient profile
Tranexamic acid is the synthetic lysine analog 4-(aminomethyl)cyclohexane-1-carboxylic acid. In medicinal use it functions as an antifibrinolytic; in cosmetic use it is positioned around skin tone uniformity and pigment-related concerns.
OEM applications
In Japanese cosmetics, tranexamic acid appears in medicated whitening products, often in serum and lotion formats.
Regulatory classification in Japan
Approved as a quasi-drug whitening active by 厚生労働省 (Ministry of Health, Labour and Welfare). Pharmaceutical applications are separately regulated under prescription frameworks.
Regulatory classification in other markets
| EU | Listed in CosIng. Permitted for cosmetic use within applicable concentration ranges. |
|---|---|
| USA | INCI recognized for cosmetic use. |
| China | Permitted per IECIC listings. |
| Korea | Permitted under KFDA / MFDS for cosmetic use. |
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 lotion / serum (Japan) | 2% | 2% per 厚生労働省 quasi-drug approval (representative) | 厚生労働省 医薬部外品有効成分通知 |
| Quasi-drug anti-inflammatory acne / scalp products | 1–3% | — | Applied as anti-plasmin / anti-inflammatory active |
Stability & compatibility
- pH range
- pH 3–9 (broadly stable)
- Temperature
- Highly stable; tolerates standard hot-process formulation
- Incompatibilities
- Strong oxidizing agents
One of the most formulation-friendly whitening actives in Japan; compatible with most surfactant systems.
Storage requirements
How the receiving OEM facility needs to handle inbound raw material.
- Temperature
- Room temperature ≤30°C
- Conditions
- Dry, sealed in original packaging
- Shelf life
- 36 months sealed (one of the most stable whitening actives)
Supplier safety data sheet
Supply concentration
Where this ingredient comes from — useful for single-source-risk planning.
- Primary regions
- Synthetic; major suppliers in Japan, China, India
- Import dependence
- Pharmaceutical-grade USP / JP grades sourced globally; cosmetic-grade follows
Certifications commonly available
Certification schemes commonly obtainable for this raw material. Always confirm the specific supplier's current certificate before contracting.
| Scheme | Availability | |
|---|---|---|
| GMP (pharmaceutical / quasi-drug) | Standard | |
| Halal | On-request | |
| Kosher | On-request | |
| Vegan | Common | Synthetic origin |
Alternative ingredients
Related ingredients commonly evaluated as substitutes.
Quick answers
- What is Tranexamic Acid?
- Tranexamic acid is a synthetic lysine analog originally developed in 1962 by Shosuke and Utako Okamoto at Keio University in Japan as an antifibrinolytic pharmaceutical. In cosmetic use, the compound is approved as a quasi-drug whitening active in Japan, where it is positioned around interrupting inflammation-related contributors to hyperpigmentation. The pharmaceutical use and cosmetic use are entirely separately regulated.
- What is the regulatory status of Tranexamic Acid in Japan?
- Approved as a quasi-drug (医薬部外品) whitening active by 厚生労働省 (Ministry of Health, Labour and Welfare). Pharmaceutical use is regulated separately.
- What products typically use Tranexamic Acid?
- Medicated whitening products (薬用美白) / Spot-care treatment products / Pharmaceutical applications (separate context)
- Where does Tranexamic Acid come from?
- Synthetic (developed in Japan)
- What is the INCI / JSCI labeling name for Tranexamic Acid?
- INCI: Tranexamic Acid / JSCI: トラネキサム酸
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From the same origin
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Regulatory guidance
Take the next step
FAQ for OEM buyers
Q. Is tranexamic acid approved for whitening claims in Japan?
Yes — tranexamic acid is approved by 厚生労働省 (Ministry of Health, Labour and Welfare) as a quasi-drug whitening active for prevention of melasma-related pigmentation; finished products must be filed as quasi-drugs to make this claim.
Sources · Last reviewed: 2026-04-26
- 厚生労働省 (Ministry of Health, Labour and Welfare) — quasi-drug whitening actives (tranexamic acid)
Q. What is the regulatory status outside Japan?
Tranexamic acid is widely used in cosmetics in Korea, China (registered actives lists), and the EU as a non-medicinal cosmetic ingredient. In the US it is used as a cosmetic ingredient (separate from its prescription oral/topical drug uses).
Sources · Last reviewed: 2026-04-26
- China NMPA — Inventory of Existing Cosmetic Ingredients (IECIC)
- Korea MFDS — cosmetic ingredient listings
Industry-knowledge claim — not yet pinned to a single primary source
Q. What use level is typical and what are the formulation considerations?
Japanese quasi-drug whitening lotions use tranexamic acid at around 2–3%; it is freely water-soluble, stable across a wide pH range (~3–9), and easy to formulate into clear toners and serums.
Sources · Last reviewed: 2026-04-26
- Industry knowledge — tranexamic acid formulation practice
Industry-knowledge claim — not yet pinned to a single primary source
Q. Can it be combined with other whitening actives?
Yes — tranexamic acid is commonly co-formulated with niacinamide, ascorbyl glucoside, and arbutin in Japanese medicated whitening serums. Combination claims must still fit within quasi-drug-permitted language.
Sources · Last reviewed: 2026-04-26
- Industry knowledge — Japanese medicated whitening combinations
Industry-knowledge claim — not yet pinned to a single primary source
Use cases
Medicated whitening lotion (Shiseido HAKU-style lineup)
- Positioning
- Premium daily-use medicated whitening
- Typical usage level
- 2–3% (Japan quasi-drug)
- Formulation notes
- Clear water-phase formulation; pair with niacinamide for combined claim.
Sources
- Industry knowledge — Japanese premium whitening category
Industry-knowledge claim — not yet pinned to a single primary source
Brightening serum / ampoule
- Positioning
- Targeted melasma-care positioning
- Formulation notes
- Higher-strength leave-on; combine with arbutin or vitamin C derivatives.
Sources
- Industry knowledge — melasma-targeted serum category
Industry-knowledge claim — not yet pinned to a single primary source
Sensitive-skin brightening cream
- Positioning
- Anti-inflammatory + brightening dual positioning
- Formulation notes
- Combined with dipotassium glycyrrhizate and ceramides for sensitive-skin lines.
Sources
- Industry knowledge — sensitive-skin brightening segment
Industry-knowledge claim — not yet pinned to a single primary source
Sheet mask
- Positioning
- Spot-care single-use mask
- Formulation notes
- Compatible with niacinamide and HA in standard mask serum bases.
Sources
- Industry knowledge — Asian brightening mask category
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
Last updated: 2026-04-22. Ingredient entries are reviewed at least annually against current regulatory listings.