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Tranexamic acid & alpha-arbutin serum OEM/ODM manufacturing
Tranexamic Acid & Alpha-Arbutin Serum · OEM/ODM
Tranexamic acid and alpha-arbutin are two brightening actives that act at different steps of pigment formation. Tranexamic acid is thought to reduce pigment signaling via the plasmin pathway — mechanistic data come mainly from guinea pigs and one small uncontrolled study; alpha-arbutin inhibits tyrosinase and lowers melanin in cultured human melanoma cells and a three-dimensional skin model (laboratory data). The two also have different regulatory standing: tranexamic acid is capped at 3.0% and not allowed in products intended to contact mucous membranes (ASEAN Annex III, Ref A10); alpha-arbutin has no entry of its own in the ASEAN Annexes, the 2% level for face creams is the SCCS safety assessment, and as a glycoside of hydroquinone, free hydroquinone must be tested. Topical evidence for each active is still limited and this exact pairing has not been tested, so the claim stops at “helps skin look brighter and more even”, always with a sunscreen recommendation. Butter-C offers full-service OEM/ODM manufacturing, from raw material selection and formula development to a labeled finished product with its cosmetic product notification.
Formula base
Two actives, two regulatory statuses
The serum consists of two water-soluble actives dissolved in the water phase, a light hydrating base and a buffer that keeps the pH out of the acidic range. The sources Butter-C has checked include no study of the tranexamic acid – alpha-arbutin pair itself; the complete formula needs stability and tolerance testing.
Tranexamic Acid up to 3.0%
Legal limit: skin products, maximum 3.0%, not in products intended to contact mucous membranes (Annex III Ref A10, no mandatory label warning). Topical forms have been tested at 2% (12 weeks, open-label, 23 people) and as a 3% cream (8 weeks, split-face, 20 people) — all in people with pigmentation disorders, in a medical setting. One 5% gel trial did no better than its vehicle and caused more redness; 5% also exceeds the ASEAN cosmetic cap.
Alpha-Arbutin up to 2%
The SCCS considers it safe up to 2% in face creams and 0.5% in body lotions. The ASEAN Annexes have no entry for it — this is a scientific reference level, not a legal limit; going above it requires separate safety data in the PIF. Alpha-arbutin inhibits tyrosinase from mouse melanoma cells (in the same study it did not inhibit mushroom tyrosinase, the enzyme often used in screening assays); in a three-dimensional human skin model, melanin fell to 40% of control. Clinical evidence for alpha-arbutin alone is limited: the human studies checked all used combination formulas, and one had no control group.
Niacinamide (optional)
Tranexamic acid 2% + niacinamide 2% is a combination with a randomized, double-blind, vehicle-controlled trial: 42 women, 8 weeks, with sunscreen. Niacinamide does not inhibit tyrosinase; it reduces pigment transfer to keratinocytes — one more step.
Hydrating and soothing base
Glycerin, Butylene Glycol, Sodium Hyaluronate, Panthenol, Allantoin; electrolyte-tolerant polymers such as Hydroxyethylcellulose or Xanthan Gum, since tranexamic acid carries both an amine and a carboxyl group and can affect viscosity.
Key technical points
Keeping arbutin from turning into hydroquinone
Hydroquinone is banned in cosmetics (ASEAN Annex II, Ref 1339) and is a breakdown product of arbutin. The four items below decide whether the serum's file holds up.
Heat, pH and light
Arbutin breaks down into hydroquinone and p-benzoquinone under heat, UV or dilution in acidic conditions. Alpha-arbutin is added at the cool-down phase without prolonged heating; AHAs and exfoliating acids are not put in the same bottle; the pH range is settled by stability testing with hydroquinone assays.
The right test method
Arbutin interferes with UV-VIS spectrophotometry for hydroquinone and can give false results; Butter-C uses HPLC to quantify arbutin, hydroquinone and p-benzoquinone together in the raw material and across stability time points. Alpha-arbutin can be synthesized enzymatically from hydroquinone, so free hydroquinone on the COA is the key parameter.
The right substance, the right name
Alpha-Arbutin and Arbutin (beta) are two different INCI names with different SCCS levels; deoxyarbutin is banned (Annex II, Ref 1657). The SCCS has not assessed combined use of several hydroquinone-releasing substances, so the formula adds no other arbutin or derivative. For tranexamic acid, the CAS number on the COA is checked.
Scope of use and label directions
Under the Ref A10 condition: no lip or intimate-area versions; an eye cream needs separate regulatory confirmation. Directions say avoid lips and eyes and use sunscreen during the day; people using prescription tranexamic acid should ask their doctor before adding the serum.
Three formulation directions
The same pair of actives, three ways to combine them
Two-active serum
Tranexamic acid 2–3%, alpha-arbutin no more than 2%, a light hydrating base; morning and evening, with sunscreen during the day. For dull, uneven-looking skin.
Three-active serum with niacinamide
Adds niacinamide 2% following the 2% + 2% combination with tranexamic acid that has human data. One more HPLC parameter, and more thorough tolerance testing.
Gentle serum-gel for sensitive skin
Tranexamic acid and alpha-arbutin below their caps, more Panthenol and Allantoin, fragrance-free. Trades some intensity for tolerance; hydroquinone is still tested batch by batch.
Packaging is designed with the formula
UV accelerates arbutin breakdown: amber glass, opaque light-blocking bottles or airless pumps, with a carton; dropper and gasket materials are soak-tested with the samples.
Parameters we monitor
What our R&D lab measures on every sample
Below is the set of parameters Butter-C tracks during formula development and scale-up to production. Specific limits are agreed with you on the approved sample and then written into the product's in-house specification.
- Raw material COA
- Alpha-arbutin: purity, free hydroquinone. Tranexamic acid: CAS number, purity. Niacinamide (if used): free nicotinic acid.
- Appearance & color index
- Color, odor, clarity; color index measured periodically to catch discoloration early.
- pH
- Measured directly at 25°C; pH drift tracked across stability time points — drift toward acidic raises the risk of arbutin breakdown.
- Viscosity
- Rotational viscometer, with spindle and speed recorded; matched to the dropper or pump.
- Active content
- Tranexamic acid, alpha-arbutin (and niacinamide) assayed by HPLC; tranexamic acid must be shown not to exceed 3.0%.
- Hydroquinone & p-benzoquinone
- HPLC on the raw material, the finished product and after stability time points; no UV-VIS method when arbutin is present.
- Stability
- Accelerated aging at 40°C, freeze–thaw cycling and light exposure; remaining actives and hydroquinone formed are compared — the basis for setting shelf life.
- Microbiology & preservative challenge
- Tested at a GLP / ISO 17025-accredited laboratory; preservative efficacy (challenge) test per ISO 11930.
- Irritation & tolerance
- Tested on volunteers before the formula is finalized; more redness has been reported with 5% tranexamic acid (a level outside the ASEAN cosmetic scope).
Claims
Writing claims within the cosmetic scope
Brightening products face frequent post-market checks, and the studies of both actives were done in people with pigmentation disorders, so borrowing medical language is easy. Butter-C reviews the wording on labels and marketing materials while preparing the cosmetic product notification.
Helps skin look brighter and more even
Ideally tested on the finished product, always paired with a sunscreen recommendation. Instead of: instant whitening, bleaching, erases melasma, fades melasma.
Contains tranexamic acid and alpha-arbutin
Correct INCI names; percentages only when assayed and within limits. Instead of: “tranexamic 5%”, “arbutin 5%”, “replaces hydroquinone”, “hydroquinone-free” without an HPLC result.
Daily sunscreen recommendation
Included in the directions; persistent or spreading darkening of the skin should be seen by a dermatologist. Instead of: prevents melasma from returning, removes melasma at the root.
Directions: avoid lips and eyes
Following the no-mucous-membrane condition of Ref A10. Instead of: for dark lips, intimate areas, nipples.
Hydrates, helps skin feel soft and smooth
Instead of: regenerates skin, renews skin.
Time to visible difference
Topical studies ran 8–12 weeks; numbers of days, weeks or percentages are stated only with a test on the finished product. Instead of: “brighter skin in 7 days”, “as effective as oral tranexamic acid”.
Manufacturing specifications
Current capabilities
- Texture
- Watery serum, lightly thickened gel-serum or fluid essence; clear, colorless to slightly off-white.
- Packaging format
- Amber glass or opaque light-blocking bottles with a dropper, or airless pump bottles. Volume agreed when selecting packaging.
- Minimum order quantity
- Agreed per order — depending on the formula direction and the chosen packaging format.
- Testing
- Performed at a GLP / ISO 17025-accredited laboratory, with HPLC assays of the actives and hydroquinone; a certificate of analysis delivered with each batch.
- Documentation
- Product Information File (PIF) and cosmetic product notification dossier prepared by Butter-C, including a safety assessment of alpha-arbutin against the SCCS level.
- Packaging
- Label design, printing and packing run in parallel with formula development.
Suggested product concept
Tranexamic acid – alpha-arbutin serum, 30 ml light-blocking bottle
A product direction to help you picture the idea — not a ready-made product for sale. The actual formula is developed around your brand's positioning and price range.
Tranexamic Acid 2%
A level tested topically in people with pigmentation disorders (open-label study, medical setting — not a basis for claims), within the 3.0% Annex III limit.
Alpha-Arbutin, no more than 2%
Within the SCCS safe level for face creams; hydroquinone tested batch by batch by HPLC.
Glycerin, Sodium Hyaluronate, Panthenol
A light hydrating base, fragrance-free, with no exfoliating acids.
30 ml amber glass bottle
Dropper and light-blocking carton; the label carries a sunscreen recommendation and directions to avoid lips and eyes.
Customization options
What you can specify
The same product type can serve very different customers depending on the brand. Tell us your requirements in the areas below, and our team of pharmacists will develop a matching formula.
Set of actives
Two actives or with niacinamide added — determines HPLC parameters and the extent of tolerance testing.
Concentrations
Tranexamic acid up to 3.0%, alpha-arbutin up to 2%; lower levels for a gentle version.
Time of use
Morning and evening, or evening only; a daytime version gives a more prominent sunscreen reminder.
Texture
Watery, a lightly thickened gel-serum or an essence.
Companion products
Brightening cream, sunscreen and cleanser in the same line, to sell as a set.
Ingredient direction
Fragrance-free, alcohol-free, vegan — please specify these from the start so suitable raw materials can be selected.
Further reading
Related topics
Tranexamic acid in cosmetics
The 3.0% limit and what topical forms have been tested (in Vietnamese).
Alpha-arbutin in cosmetics
The SCCS safe level and hydroquinone control (in Vietnamese).
Managing skin pigmentation
How melanin forms and where cosmetics can act (in Vietnamese).
Using sunscreen correctly
The step every brightening product depends on (in Vietnamese).
Brightening serum manufacturing
A different direction: a multi-active serum with vitamin C and its derivatives.
Dark spot brightening cream manufacturing
A different direction: a cream format with banned-substance control.
How we work
From idea to finished batch
Eight steps and three milestones signed off by both sides: approved sample, notification number, finished batch. Step-by-step details (in Vietnamese) →
Get started
Tell us about the product you plan to launch
Send us your product direction and expected volume. Our team will get back to you during business hours (Vietnam time, GMT+7).
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