Aluminum Sulfate

What Is It?

Aluminum Sulfate is a white crystalline solid. In cosmetics and personal care products, Aluminum Sulfate is used in the formulation of deodorants, makeup foundations, face and neck products, personal cleanliness products and skin fresheners.

Why Is It Used?

Aluminum Sulfate induces a tightening or tingling sensation of the skin. It also draws together or constricts body tissues which are effective in stopping the flow of blood or other secretions. Aluminum Sulfate can also reduce or eliminate unpleasant odor and protects against the formation of such odors on the skin.

Scientific Facts

Aluminum Sulfate occurs naturally as the mineral alunogenite but can also be produced synthetically. In addition to its use in cosmetics and personal care products, Aluminum Sulfate is used in water purification where it causes impurities to coagulate so they may be filtered out.

Safety Information

Aluminum Sulfate is Generally Redognized 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.) as a multipurpose food substance. This designation is a result of a review by the Food and Drug Administration (FDA). Aluminum Sulfate is also approved for use 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 at concentrations of 46 to 63%. When used in OTC drugs, it is listed on the label as Aluminum Sulfate Buffered. 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.

The FDA’s Select Committee on GRAS Substances (SCOGS) concluded that there was no evidence in the available information on Aluminum Sulfate that demonstrates, or suggests a hazard to the public when it is used at levels that are now current or might reasonably be expected in the future. http://www.cfsan.fda.gov/~dms/opascogc.html

More information about aluminum.

Link to FDA Code of Federal Regulations for Aluminum Sulfate

Aluminum Sulfate 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

Aluminum Sulfate is an inorganic salt. In cosmetics and personal care products, Aluminum Sulfate functions as an cosmetic astringentIngredients that induce a tightening or tingling sensation of the skin. and deodorant agentIngredients that reduce or eliminate unpleasant odor and that protect against the formation of such odors on the skin.. It is also approved for use in skin protectant OTC drugs as a drug astringent.

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): 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/