Safety Assessment of Alumina and Aluminum Hydroxide as Used in Cosmetics

Int J Toxicol. 2016 Nov;35(3 suppl):16S-33S. doi: 10.1177/1091581816677948.


This is a safety assessment of alumina and aluminum hydroxide as used in cosmetics. Alumina functions as an abrasive, absorbent, anticaking agent, bulking agent, and opacifying agent. Aluminum hydroxide functions as a buffering agent, corrosion inhibitor, and pH adjuster. The Food and Drug Administration (FDA) evaluated the safe use of alumina in several medical devices and aluminum hydroxide in over-the-counter drugs, which included a review of human and animal safety data. The Cosmetic Ingredient Review (CIR) Expert Panel considered the FDA evaluations as part of the basis for determining the safety of these ingredients as used in cosmetics. Alumina used in cosmetics is essentially the same as that used in medical devices. This safety assessment does not include metallic or elemental aluminum as a cosmetic ingredient. The CIR Expert Panel concluded that alumina and aluminum hydroxide are safe in the present practices of use and concentration described in this safety assessment.

Keywords: alumina; aluminum hydroxide; cosmetics; safety.

Publication types

  • Review

MeSH terms

  • Aluminum Hydroxide / analysis
  • Aluminum Hydroxide / pharmacokinetics
  • Aluminum Hydroxide / toxicity*
  • Aluminum Oxide / analysis
  • Aluminum Oxide / pharmacokinetics
  • Aluminum Oxide / toxicity*
  • Animals
  • Consumer Product Safety* / legislation & jurisprudence
  • Cosmetics / chemistry
  • Cosmetics / standards*
  • Equipment and Supplies / standards
  • Government Regulation
  • Humans
  • Molecular Structure
  • Toxicity Tests / methods
  • Toxicokinetics
  • United States
  • United States Food and Drug Administration


  • Cosmetics
  • Aluminum Hydroxide
  • Aluminum Oxide