Calamine

US over-the-counter (OTC) label

Brand or trade name

Calamine

Manufacturer

Topco Associates LLC

Label date

13 February 2026

Stated use in the United States

Purpose Skin Protectant

Label in the official openFDA API. This is the label date; the formula may have changed. Compare with the packaging.

Cosmetic analysis in the European Union

2 ingredients allowed under conditions (maximum concentration, product types): some active ingredient concentrations are printed; the other conditions and the product's classification in the European Union remain to be checked. 4 names recognised out of 6.

Warning: 2 names out of 6 are not recognised (Active ingredents Calamine 8%, bentonite magma): nothing below covers them.

Active ingredents Calamine 8%, Zinc oxide 8%, bentonite magma, calcium hydroxide, glycerin, purified water

Who it concerns

For each group, the ingredients of the list that an official classification or rule mentions. Open an ingredient's page to read what the text says. A group with no name does not mean the ingredients were judged to have no effect for it.

Prohibition or serious classificationThe text prohibits the substance for this use, or ranks it among the most serious hazards (known or presumed carcinogenic, mutagenic or reprotoxic, identified endocrine disruptor).Worth watchingThe text sets a condition or flags a hazard worth knowing: allergen, suspected effect, condition for children, hazard to the aquatic environment.For informationOfficial information with no condition on a finished product: warning to read, irritation of the pure substance.

• Environment

  • Worth watching ZINC OXIDEClassified under the CLP Regulation: hazardous to the aquatic environment, short term, category 1 (Aquatic Acute 1); hazardous to the aquatic environment, long term, category 1 (Aquatic Chronic 1).

• Read on the label

  • For information CALCIUM HYDROXIDEAnnex III, entry 15c, requires a warning that depends on the type of product: Hair straighteners containing two components: calcium hydroxide and a guanidine salt: “Contains alkali. Avoid contact with eyes. Keep out of reach of children. Can cause blindness”; pH ajuster for depilatories: “Contains alkali. Keep out of reach of children. Avoid contact with eyes”. None for: Other uses (e.g. pH adjuster, processing aid).

No official text covers the recognised ingredients for: pregnancy and breastfeeding, babies and children, skin, eyes and allergies.

For a question about your own situation (pregnancy, child, allergy), show this list to your doctor, midwife or pharmacist: we cannot say whether this product suits you.

Selling elsewhere

Ingredients of this list that are prohibited, prohibited in some cases or subject to conditions in the other countries whose rules we record (nothing changes for sale in France). Absence is not approval: several countries only allow the preservatives, UV filters and colorants on their lists, and the function of an ingredient in the product is not known. What is covered for each country.

No prohibition or condition found in the recorded lists for: United States (federal), Washington State, California, Japan, China.

Ingredient by ingredient

The line under each name gives its rule in the European Union (legend below). Click a name for its page.

Hover over or tap a badge for its meaning.

Classified hazard (cancer, DNA, reproduction): Carcinogenic, mutagenic or toxic for reproduction under the CLPEU regulation that classifies chemicals by their hazards (EC No 1272/2008). Regulation, or identified endocrine disruptor. Irritation, allergy and environment: see “Who it concerns”.

All US nonprescription labels

List in the official revision dated 13 February 2026 (register: openFDA: US OTC product labels, analysed under European cosmetic rules).

Has the product changed? Photograph the packaging.