Is Octisalate banned?
Octisalate 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.
Why Octisalate is flagged
Octisalate is FDA-approved at up to 5% and EU-permitted at up to 5%. It has a good safety record and low sensitization rate. The 2019 FDA absorption study detected systemic absorption above the 0.5 ng/mL threshold, warranting further study. This does not indicate known harm. It is a salicylate; those with aspirin sensitivity should note the structural relationship, though reactions are rare.
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