Aluminum Hydroxide

What Is It?

Aluminum Hydroxide is a stable form of aluminum. It is found in nature as the mineral gibbsite. In cosmetics and personal care products, it is used in many types of cosmetics and personal care products including makeup and eye makeup products, lipstick, cleansing products, lotions, moisturizers, hair conditioners, other skin care products and suntan products.

Why Is It Used?

Aluminum Hydroxide functions as an 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 a 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..

Scientific Facts

When used as an antiacid, the hydroxide ion in Aluminum Hydroxide reacts with the excess acid in the stomach, reducing the acidity.

Safety Information

The Food and Drug Administration (FDA) reviewed the safety and efficacy of Aluminum Hydroxide for use in Over-the-Counter (OTC) drug products. It is permitted for use as an active ingredient in OTC antacids, and in OTC skin protectant drug products, including those intended for use in the anorectal area. The FDA also permits Aluminum Hydroxide to be used as an indirect food additiveIndirect food additives are additives that may become part of the food in trace amounts due to its packaging, storage or other handling. For example, minute amounts of packaging substances may find their way into foods during storage.. For example, it may be used as a defoaming agent in the manufacture of paper and paperboard used to package food. 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 the FDA Code of Federal Regulations:

In Europe, Aluminum Hydroxide is an approved color additive (CI 77002) that may be used in all types of cosmetics and personal care products (see Annex IV). When used as a colorantIngredients that impart color to cosmetic products. In the United States, the FDA regulates which colorants may be used in cosmetics. in cosmetic products in the European Union, this ingredient must be called CI 77002.

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

More information about aluminum.

More Scientific Information

Aluminum Hydroxide is an inorganic base. Inorganic bases are alkalies which contain no carbon atoms. When placed in water, Aluminum Hydroxide separates into cations (positively charged aluminum) and hydroxide anions (negatively charged). The hydroxide anions serve to decrease the acidity of water (increase pHA measurement of the acidity or basicity of a substance. pH is the negative logarithm (base 10) of the concentration of hydrogen ions in solution. Water has a concentration of hydrogen ions of 1.0 x 10-7, and thus has a pH of 7. A pH of 7 is considered neutral, a pH lower than 7 is considered acidic, and a pH higher than 7 is considered basic.).

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

Find out more about the regulation of Food Additives by the Food and Drug Administration

Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm

Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…

Substances Generally Recognized As Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm

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/