Aluminum Zirconium Tetrachlorohydrex Glycine

EU-restricted under Annex III Entry 50 with defined concentration limits. Dermal absorption virtually zero per landmark AMS studies — systemic exposure from cosmetic use is negligible versus dietary background. No conclusive breast cancer, neurotoxicity, or CMR link. FDA OTC drug monograph approval at up to 20%. Fully compliant use requires staying within SCCS/1613/19 equivalent-Al limits per product category and adhering to Annex III conditions of use. Not certifiable under COSMOS/ECOCERT.

Approved OTC antiperspirant active under 21 CFR 350; max 20% in OTC antiperspirant products; regulated as drug not cosmetic; labeling requires kidney disease warning and broken skin warning (21 CFR 350.50)