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BHA salicylic acid toner OEM/ODM manufacturing
BHA Salicylic Acid Toner · OEM/ODM
Salicylic acid — BHA — is the familiar active of products for oily skin: a lipophilic aromatic acid described as loosening the bonds between corneocytes rather than cutting keratin fibers, which helps the skin surface feel smoother and helps clear sebum and dead cells from pores. Putting it into a toner is a problem of its own: salicylic acid dissolves only to about 0.2% in water, its pKa of 2.98 means pH decides how much free acid is present, and ASEAN Annex III (Ref 98) caps it at 2.0% for facial products — counting every use of salicylic acid in the formula, including any used as a preservative — while ruling out applications that may be inhaled, so a BHA toner is not made as a fine-mist spray. Human data for BHA are mostly 1.5–2% creams and gels in a dermatology setting, and a 2020 Cochrane review rated the comparisons involving salicylic acid as low to very low quality evidence; a cosmetic toner therefore claims cleansing and smoothing only, not an effect on acne. Butter-C offers full-service OEM/ODM manufacturing, from solvent system, pH selection and tolerance testing to a labeled finished product with its cosmetic product notification.
Formula base
Choose the form of BHA first; the solvent system follows
The same word “BHA” on a label can mean crystalline salicylic acid, a salicylic acid complex or a derivative. Each form dissolves differently, converts differently against the limit and carries a different level of evidence, so this is the first decision in the formula.
Crystalline salicylic acid
INCI Salicylic Acid (CAS 69-72-7, molecular weight 138.12). Water solubility about 2.24 mg/mL at 25 °C; readily soluble in alcohol (about 35% by weight in absolute ethanol at 21 °C, Merck Index via PubChem). Most human data use this form: 1.5–2% in creams and hydrogels. The ceiling for a facial toner is 2.0% (Annex III Ref 98, “other products”).
Betaine salicylate
A 1:1 betaine – salicylic acid compound; 1 g contains about 0.541 g of salicylic acid, so 2% betaine salicylate corresponds to only about 1.08% salicylic acid. It is not named in the ASEAN annexes; Butter-C converts with the 0.541 factor and applies all Ref 98 conditions — a cautious reading that needs regulatory confirmation. The “gentle BHA” label currently rests on laboratory data: limited evidence.
Capryloyl salicylic acid (LHA) — for comparison
A highly lipophilic derivative (XLogP 5.2 versus 2.3 for salicylic acid), described in a review as penetrating the stratum corneum more slowly. In 2024 the CIR Expert Panel concluded the available data are insufficient to determine LHA safe under intended conditions of use, and contact allergy cases have been reported. LHA is therefore not part of the default toner direction; it is considered only when the supplier provides a safety file and the finished product passes tolerance testing.
What goes with BHA
Solvents Propanediol, Butylene Glycol (or alcohol in the quick-dry version); moisturizing and soothing with Glycerin, Betaine, Panthenol, Allantoin (Allantoin only when the finished pH is 4 or above — the ingredient monograph gives a pH range of 4–8). No AHA, retinoid or niacinamide in the same bottle — BHA stays the lead and the formula pH does not have to serve two actives.
Key technical points
Four things specific to a toner named after BHA
A toner is almost all water, with no oil phase or thickener to hide behind: crystallizing, discoloring or exceeding the limit all show. The four items below are settled before skin feel or packaging is discussed.
Dissolving and crystallization
Salicylic acid is predissolved in glycol or alcohol before it goes into the water phase; with too little solvent, crystals appear on dilution or in the cold. The solvent level is set by testing at 4 °C and through freeze–thaw cycling. Partial neutralization increases the dissolved salt form but reduces free acid — the two goals pull in opposite directions.
pH and free acid
With a pKa of 2.98, the un-ionized fraction of salicylic acid is about 49% at pH 3.0, 23% at pH 3.5, 9% at pH 4.0 and 3% at pH 4.5 (calculated from pKa). CIR could not identify a pH threshold that ensures non-irritation, so pH is settled together with human tolerance testing rather than taken as a default number.
Counting the total under Ref 98
Maximum 2.0% in facial products, and “These levels are inclusive of any use of salicylic acid”: add free acid, the portion neutralized into salt, the portion converted from betaine salicylate (a cautious reading that needs regulatory confirmation) and any used as a preservative (Annex VI Ref 3, maximum 0.5% as acid). If the alcohol is denatured with salicylic acid (CIR lists denaturant among its functions), that portion counts too — ask the alcohol supplier which denaturant is used. The purpose must be other than preservation and apparent from the product presentation.
No spray, light protection, color control
Ref 98 excludes applications that may lead to exposure of the user’s lungs by inhalation: a BHA toner uses a flip-top or screw cap or pre-soaked pads, never a fine-mist sprayer. Salicylic acid gradually discolors in sunlight (Merck Index, via PubChem), so light-protective packaging is used; salicylate gives a color with iron ions, so the formula includes the chelator Disodium EDTA and water and equipment are controlled.
Three formulation directions
Three ways to put BHA in a toner bottle
Alcohol-free BHA toner, glycol base
Salicylic acid dissolved in Propanediol and Butylene Glycol, partly neutralized; a moist feel with no alcohol smell. The common direction for oily and combination skin, used daily or every other day.
Betaine salicylate toner
Labeled “contains betaine salicylate”, with the salicylic acid equivalent kept in the dossier. A gentle positioning for first-time BHA users; “gentler” is claimed only when the finished product itself has passed human tolerance testing.
Water – alcohol BHA toner, quick-dry
Alcohol dissolves salicylic acid well and evaporates quickly, suiting very oily skin and hot, humid climates. The trade-off is tightness: it needs added humectants and documentation of the alcohol’s denaturant.
Packaging must be planned with the formula
Light-protective plastic or glass bottles with a flip-top or reducer cap for pouring onto a pad; pre-soaked pads in a sealed jar need their own solvent-evaporation and microbiology tests. No fine-mist sprayers. Plastics and gaskets are soak-tested with the acid – glycol solution.
Parameters we monitor
What our R&D lab measures on every sample
Below are the parameters Butter-C tracks during formula development and scale-up. Specific limits are agreed with you on the approved sample and then written into the product’s in-house specification.
- Appearance & clarity
- Color, odor, clarity; compared with a reference sample kept in the R&D lab — salicylic acid discolors with light or metal ions.
- pH
- Measured directly at 25°C on every lot; pH drift tracked through stability checkpoints, since pH decides the free-acid fraction.
- Salicylic acid content
- HPLC assay at release and through stability checkpoints; expressed as total salicylic acid (including salt and converted portions) against the 2.0% limit.
- Low-temperature crystallization
- Storage at 4°C and freeze–thaw cycling; inspection for crystals at the bottom, neck and cap.
- Density & conductivity
- Two quick lot-identity checks for a water – glycol system, catching mixing deviations.
- Stability
- Accelerated aging at 40°C, freeze–thaw cycling and light exposure; watching for discoloration, precipitation and odor change.
- Packaging compatibility
- Filled into the actual bottle and cap; watching for solvent loss, plastic deformation and gasket discoloration.
- Microbiology & preservative challenge
- Tested at a GLP / ISO 17025-accredited laboratory; preservative efficacy (challenge) test per ISO 11930 — a low pH does not replace the test.
- Irritation & stinging
- Human volunteer testing before the pH and salicylic acid level are fixed — the basis for CIR’s condition of formulating to be non-irritating and non-sensitizing.
Claims
Writing claims within the cosmetic scope
Most salicylic acid trials were done in people with acne and compared against prescription actives, so marketing copy slides easily into dermatology language. A cosmetic toner stops at cleansing, smoothing and describing the suitable skin type. Butter-C reviews label and marketing wording when preparing the notification dossier.
Helps clear sebum and dead cells from pores
Instead of: unclogs pores, removes blackheads, comedolytic.
Helps the skin shed dead cells for a smoother surface
Instead of: peels the skin, skin renewal, skin regeneration.
Suitable for oily, blemish-prone skin
Describes who uses it, not an effect on acne. Instead of: claims of an effect on acne, reduces inflamed breakouts, prevents acne, acts on acne bacteria.
Contains salicylic acid (BHA)
The amount is stated only when an assay proves it and every source of salicylic acid has been added up. Instead of: stacking “2% BHA” with betaine salicylate into a figure above the ceiling, “peel-strength”.
Helps control excess oil
Only when measured on the finished product: salicylic acid’s reduction of lipid synthesis has so far been shown only in cultured sebocytes. Instead of: permanently reduces sebum, shrinks pores.
Directions and label notes
Avoid the eye area; start every other day; do not layer several products containing salicylic acid; use retinoids and AHAs at a different time; use sunscreen during the day (general advice — Ref 98 has no sunburn warning). The sentence “Not to be used for children under three years of age” is mandatory for products that might be used for children under three — footnote (8) of Annex III: “Solely for products which might be used for children under three years of age”; an adult oily-skin toner may carry it as a voluntary note. Instead of: safe in pregnancy, suitable for young children.
Manufacturing specifications
Capabilities
- Texture
- Clear, colorless liquid; alcohol-free glycol base or quick-dry water – alcohol base.
- Formats
- Flip-top or screw-cap bottles, or pre-soaked pads in a sealed jar; no fine-mist sprayer. Volume agreed when packaging is selected.
- Minimum order quantity
- Agreed per order — depends on the form of BHA and the chosen format.
- Testing
- Tested at a GLP / ISO 17025-accredited laboratory, including salicylic acid assay; certificate of analysis supplied with every lot.
- Documentation
- Product Information File (PIF) and cosmetic product notification prepared by Butter-C, including the total salicylic acid calculation under Annex III Ref 98.
- Packaging
- Label design, printing and packing run in parallel with formula development.
Suggested product concept
Alcohol-free, fragrance-free BHA toner for oily skin
One product direction to help you picture the result — not a ready-made product for sale. The actual formula is built around your brand positioning and price range.
Salicylic acid
The named active; level set by tolerance testing, total salicylic acid not above 2.0%. The 1.5–2% range is what has been tested in humans in creams and hydrogels.
Propanediol, Butylene Glycol
Solvent system that keeps salicylic acid in solution throughout shelf life; ratio set by crystallization testing at 4°C.
Glycerin, Panthenol, Allantoin
Replenish moisture and ease the tight feeling after acid; Allantoin only when the finished pH is 4 or above; fragrance-free, alcohol-free.
150 ml light-protective plastic bottle with flip-top cap
Poured onto a cotton pad and swept over the face; the label gives frequency of use, eye-area caution and daytime sunscreen advice.
Customization options
What you can specify
Within the same product type, every brand targets a different customer. Tell us your requirements in the areas below and our pharmacists will build the formula to match.
Form of BHA
Crystalline salicylic acid or betaine salicylate — determines the solvent system, how the limit is calculated and the label wording.
Salicylic acid level and pH
Stronger for very oily skin or lighter for first-time users; the two are different level – pH pairs, settled by tolerance testing.
With or without alcohol
Quick-dry and fresh, or moist and gentle; decide early, since switching means changing the whole solvent system.
How it is used
Poured onto a pad, patted on by hand or pre-soaked pads; not as a spray.
Moisturizing and soothing group
Glycerin, Betaine, Panthenol, Allantoin; a few well-chosen ingredients rather than a long list.
Ingredient preferences
Fragrance-free, alcohol-free, paraben-free, vegan — please state these at the outset so we can select suitable raw materials.
Further reading
Related knowledge
Salicylic acid (BHA) in cosmetics
Mechanism, evidence, ASEAN Annex III limits and safety notes (in Vietnamese).
Betaine salicylate in cosmetics
The 0.541 conversion factor and why “gentle BHA” is still limited evidence (in Vietnamese).
Capryloyl salicylic acid (LHA)
A lipophilic derivative and CIR’s 2024 “insufficient data” conclusion (in Vietnamese).
Blackheads and whiteheads
The main customer group for a BHA toner and where a cosmetic product stops (in Vietnamese).
Blemish serum manufacturing
A different direction: a concentrated serum pairing BHA with niacinamide and zinc — its own pH problem; used together with a BHA toner, cumulative exposure must be considered.
Toner manufacturing
Hydrating and balancing toners, where acids are just one option among many.
Facial exfoliator manufacturing
Rinse-off formats: scrubs, enzymes, peeling gels, used once or twice a week.
PHA gluconolactone toner manufacturing
A gentler direction for sensitive skin, outside the salicylic acid limit.
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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