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Ensulizole 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.
Ensulizole is approved by the FDA at up to 4% and in the EU at up to 8%. It is water-soluble and less likely to cause sensitivity reactions than oil-soluble filters. Minimal systemic absorption is documented. No established carcinogenicity or endocrine disruption. As with other UV filters, phototoxicity and photocontact dermatitis are very rare possibilities.
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