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.
- For US market water resistance substantiation, we conduct FDA-compliant testing using 40 human subjects following the 21 CFR 201324 protocol.
- Testing requires 4 weeks minimum after formula finalization, with MOQ of 5,000 units to justify testing costs.
- Documentation includes detailed test reports, subject consent forms, and methodology that supports your FDA submission.
- Packaging must include ‘Water Resistant (80 minutes)’ as per FDA labeling requirements, with lead time extended by 3-4 weeks to incorporate testing results into production batch records.
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.