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?

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 protectantAn ingredient that temporarily protects injured or exposed skin from harmful or annoying stimuli, and that may provide relief to such skin. In the United States, skin protectants are regulated as Over-The-Counter (OTC) drug ingredients. drug products and in anorectal drug products. The Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (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.

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 UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..

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 agentSubstances that reduce the clear or transparent appearance of cosmetic products. Some opacifying agents are used in skin make-up for hiding blemishes. 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/