Quick Answer (for busy buyers)
Here’s the buyer-first summary. If your brand name is on the label, you usually act as the responsible person and must ensure the listing is submitted and kept current.
- In the US, dandruff control claims can trigger OTC drug regulations if they imply therapeutic effects.
- We recommend using cosmetic-only claims like ‘helps reduce visible flakes’ with mild actives like zinc pyrithione at 0.5-1% concentration.
- Our MOQ starts at 5,000 units for sampling, with 2-3 week turnaround for stability and compatibility testing.
- We provide full documentation including ingredient safety assessments and claim substantiation support.
- Packaging must clearly state cosmetic status, and lead time is 8-12 weeks after formula approval.
- We can help structure your claim language to stay within cosmetic boundaries while delivering effective results.
Buyer outcome
A launch-ready compliance plan: inputs collected, roles assigned, and update cadence defined.
Most common blocker
Missing facility information + inconsistent ingredient/label snapshots across SKUs.
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This page is a practical buyer guide. For definitive requirements and updates, use FDA resources and qualified regulatory counsel.