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 eye cream and eye patches sold in the U.S. as cosmetics, MoCRA may require FDA facility registration and cosmetic product listing, depending on the roles in the supply chain.
- In most private label cases, the brand owner/Amazon seller (as the U.S.
- Responsible Person) files the product listing, while the manufacturer provides supporting details.
- If you plan drug-like claims (e.g., treating medical conditions), requirements can change, so please confirm your claim direction.
- From our side, we can help prepare the practical package: formula/INCI and shade/variant info, product concept and labeling copy support, and testing/document tracking (we can arrange product inspection and follow the report).
- We can also provide standard manufacturing credentials and documentation support.
- Execution-wise, our typical MOQ is 1,000-3,000 units (simple items like masks can start at 1,000; more complex sets often 3,000).
- Bulk production is usually 10-20 working days after final sample approval.
- Packaging ordering often takes 10-30 working days (e.g., glass bottle ~15 days, acrylic bottle ~30 days; single box ~15 days).
- Do you already have a designated U.S.
- Responsible Person and final claim set?
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.
