Salicylic acid
Salicylic acid is 2-hydroxybenzoic acid, a white crystalline powder. Commercial material is made synthetically, usually by carboxylating sodium phenoxide with carbon dioxide (the Kolbe-Schmitt process) and acidifying, then purifying by crystallization or sublimation. It dissolves poorly in water, so formulators dissolve it in alcohols or glycols or partly neutralize it. Skin care buyers usually purchase USP or Ph. Eur. grade powder.
Suppliers sell different products under the same name. Specify the one you need.
Pharmacopeial grade crystalline powder, the usual choice for OTC drug products and leave-on cosmetics.
Lower-purity material for industrial uses; not suitable for skin care because impurity limits are looser.
Finer particle size grades that dissolve faster in solvent systems and suspend better in rinse-off products.
Salicylic acid supplied dissolved in a glycol or other solvent at a stated percentage, easier to add to water-based formulas.
Compare each result with your own specification when the lot arrives.
Keep salicylic acid in a closed container in a cool, dry place away from light, since it can slowly discolor; avoid contact with iron, which turns it pink or violet. It is stable for years when kept dry, and shelf life and retest dates come from the supplier.
Lots differ mainly in particle size and trace impurities, so record the assay and related substances from each COA and check color on receipt. Keep pharmacopeial and technical grades physically separate.
Facts from regulators and standards bodies, each linked to its source.
Health Canada's Cosmetic Ingredient Hotlist restricts salicylic acid in cosmetics to a maximum concentration of 2%.
Source: canada.ca (opens in a new tab)21 CFR 333.310 lists salicylic acid, 0.5 to 2 percent, as a permitted active ingredient in the OTC topical drug monograph in part 333.
Source: ecfr.gov (opens in a new tab)21 CFR 358.710 lists salicylic acid, 1.8 to 3 percent, as an active ingredient in the OTC monograph for dandruff and seborrheic dermatitis products.
Source: ecfr.gov (opens in a new tab)Health Canada's Natural Health Products Ingredients Database says topical products with more than 20% salicylic acid or a pH below 3.0 fall under the Prescription Drug List, except products for warts, corns or calluses.
Source: webprod.hc-sc.gc.ca (opens in a new tab)This is general information, not regulatory advice. Status differs by country and by how the ingredient is used, so check the rules for your product and market.
Manufacturers and distributors whose own websites say they sell it.
Distributor · Redmond, WA
US supplier of cosmetic ingredients repackaged in retail and bulk sizes, covering actives, butters, oils, waxes and emulsifiers for brands, contract manufacturers and independent formulators.
Suppliers are in alphabetical order and none pays to appear. Each claim is checked against the supplier’s own website on the date shown. Ask for the specification sheet and a recent COA before you order, and confirm details with the supplier.
Common forms include uSP or Ph. Eur. powder, technical grade, micronized powder and pre-dissolved solutions. Ask each supplier for the specification sheet of the exact grade they quote.
Expect assay (titration), related substances (HPLC), identity (IR), loss on drying and residue on ignition and heavy metals and chloride, each with its method, specification and result for that lot.
Keep salicylic acid in a closed container in a cool, dry place away from light, since it can slowly discolor; avoid contact with iron, which turns it pink or violet. It is stable for years when kept dry, and shelf life and retest dates come from the supplier.
Health Canada's Cosmetic Ingredient Hotlist restricts salicylic acid in cosmetics to a maximum concentration of 2%. 21 CFR 333.310 lists salicylic acid, 0.5 to 2 percent, as a permitted active ingredient in the OTC topical drug monograph in part 333. 21 CFR 358.710 lists salicylic acid, 1.8 to 3 percent, as an active ingredient in the OTC monograph for dandruff and seborrheic dermatitis products. Health Canada's Natural Health Products Ingredients Database says topical products with more than 20% salicylic acid or a pH below 3.0 fall under the Prescription Drug List, except products for warts, corns or calluses.
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