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Dimethicone 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.
Dimethicone has an excellent safety record. The CIR has reviewed it extensively and confirmed safety at cosmetic use concentrations. It is non-allergenic, non-comedogenic, and does not penetrate intact skin. It is FDA-approved as an OTC skin protectant (1–30%). Environmental concerns exist because high-molecular-weight dimethicone is not biodegradable and accumulates in aquatic sediments; this is a sustainability concern rather than a human health issue. No carcinogenic or endocrine effects are documented.
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