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Urea (Cosmetic) is permitted by the US FDA. Several countries restrict, warning-label, or have reviewed it for safety concerns. The US has more lenient additive rules than the EU, UK, Canada, and Japan, which is why this ingredient remains widely used here.
Cosmetic urea is safe and has been used for decades in dermatology for very dry and keratotic skin conditions. The CIR has confirmed safety at cosmetic concentrations. At concentrations above 10%, it may cause mild stinging on broken or inflamed skin. No carcinogenicity or hormone disruption is documented. Urea is considered an active ingredient in OTC skin softeners in Europe.
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