Calamine

What Is It?

Calamine is a mixture of zinc oxide and iron oxide. In cosmetics and personal care products, Calamine is used in the formulation of body and hand products, paste masks and other skin care products.

Why is it used in cosmetics and personal care products?

Calamine has the capacity to absorb or soak up liquids. It also reduces the clear or transparent appearance of cosmetics and personal care product products. Calamine can be used in skin makeup for hiding blemishes and temporarily protects injured or exposed skin from harmful or annoying stimuli and may provide relief to the skin.

Scientific Facts:

Calamine is a mixture of inorganic chemical compounds used in calamine lotion and does not refer to the mineral by the same name.

Safety Information:

Based on a review of safety and efficacy, the Food and Drug Administration (FDA) permits the use of Calamine as an active ingredient in Over-the-Counter (OTC) skin protectant drug products and in anorectal drug products. The Cosmetic Ingredient Review (CIR) has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.

More safety Information:

Link to FDA Code of Federal Regulations for Calamine

Calamine may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union.

Link to the EU Cosmetic Regulation: 
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

More Scientific Information:

Calamine consists primarily of zinc oxide with the addition of approximately 0.5% ferric oxide. In cosmetics and personal care products, Calamine functions as an absorbent, opacifying agent and skin protectant.

Resources:

Find out more about the regulation of over-the-counter drugs by the Food and Drug Administration

OTC Drug Home Page: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSa…

Information about OTC Drug monographs: https://www.fda.gov/drugs/over-counter-otc-drug-monograph-process

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/