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 U.S. baby care SKUs, retailers typically demand Certificate of Analysis (COA) for each batch, Safety Data Sheet (SDS), stability testing data, and microbial reports.
- Our MOQ starts at 3,000 units per SKU, with sampling taking 2-3 weeks including documentation.
- We conduct 3-month stability testing at 25°C/60% RH and 40°C/75% RH, with microbial testing per USP .
- Packaging must include child-resistant features where applicable.
- Lead time for full documentation is 4-6 weeks from formula approval.
- We support all required testing but cannot guarantee regulatory approval as final responsibility lies with the brand.
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.