Calamine
Calamine suppliers and sourcing guide
Calamine is a pink powder of zinc oxide with a small amount of ferric (iron) oxide, which gives the color. Pharmacopeial calamine is made by blending or co-precipitating the two oxides to a set zinc oxide content; historically it was ground zinc carbonate ore. Brands buy it as a fine powder for lotions, creams and powders where it is the declared OTC skin protectant active.
- Category
- Cosmetic actives
- Also known as
- Prepared calamine · Zinc oxide with ferric oxide · Iron oxide-zinc oxide mixture
- Facts checked
- November 2026
Forms and grades of calamine
Suppliers sell different products under the same name. Specify the one you need.
Pharmacopeial powder
USP or Ph. Eur. calamine with a defined zinc oxide assay, used when calamine is the declared active.
Fine or micronized grades
Smaller particle sizes that suspend better in lotions and feel smoother on skin.
Color-matched grades
Grades with controlled iron oxide content for consistent pink shade between lots.
What to check on the COA
Compare each result with your own specification when the lot arrives.
- Zinc oxide assay
- Zinc oxide content after ignition, by complexometric titration, against the compendial range.
- Loss on ignition
- Weight lost on heating, which reflects carbonate and moisture.
- Acid-insoluble substances
- Residue insoluble in acid, which flags silica or other mineral contamination.
- Heavy metals
- Lead, arsenic, cadmium and mercury by ICP-MS, important for any mineral oxide.
- Microbiology
- Total aerobic count, yeast and mold, as the powder goes into water-based lotions.
- Color and particle size
- Shade against a standard and particle size distribution.
Storage, lots and expiry
Storage and shelf life
Store calamine in closed containers in a dry place; it is stable but picks up moisture and odors if left open. Keep dust down when handling. Shelf life and retest dates are set by the supplier's specification.
Lots and expiry dates
Record zinc oxide assay and color for each lot, since iron oxide content changes the finished shade. Check particle size when switching suppliers, as it affects lotion settling.
Regulatory status
Facts from regulators and standards bodies, each linked to its source.
21 CFR 347.10 lists calamine at 1 to 25 percent as an OTC skin protectant active ingredient.
Source: ecfr.gov (opens in a new tab)Health Canada's Medicated Skin Care Products Monograph lists calamine (iron oxide mixture with zinc oxide) at 1 to 25% as a medicinal ingredient.
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.
Calamine suppliers
Manufacturers and distributors whose own websites say they sell it.
We are checking calamine suppliers now
Every listing is checked against the supplier’s own website before it goes live, so this list fills in over the coming weeks. The specs and COA checklist above are ready today.
Sell calamine? Request a listingFrequently asked questions
What forms of calamine can brands buy?
Common forms include pharmacopeial powder, fine or micronized grades and color-matched grades. Ask each supplier for the specification sheet of the exact grade they quote.
What should the COA for calamine include?
Expect zinc oxide assay, loss on ignition, acid-insoluble substances, heavy metals, microbiology and color and particle size, each with its method, specification and result for that lot.
How should calamine be stored?
Store calamine in closed containers in a dry place; it is stable but picks up moisture and odors if left open. Keep dust down when handling. Shelf life and retest dates are set by the supplier's specification.
What is the regulatory status of calamine?
21 CFR 347.10 lists calamine at 1 to 25 percent as an OTC skin protectant active ingredient. Health Canada's Medicated Skin Care Products Monograph lists calamine (iron oxide mixture with zinc oxide) at 1 to 25% as a medicinal ingredient.
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