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. lip care (non-SPF), the biggest label risks we see are drug-like claims (“treats”/”heals”/”repairs eczema”), missing net contents, and incomplete ingredient declaration.
- Send us your full label text, PDP/back panel layout, and your Amazon bullets; we will review for: product identity (e.g., Lip Balm), net wt in oz + g, INCI ingredient list in descending order, responsible party/distributor name + U.S. address, batch/lot coding, and clear cautions (e.g., external use only where appropriate).
- If you plan SPF, that typically shifts into OTC requirements (Drug Facts); we can help you choose a safer cosmetic positioning if you want to avoid that path.
- On OEM/ODM execution: we can do custom formula and lab sampling; typical first samples are 7-14 business days after brief confirmation, with 1-3 revision rounds.
- MOQ is often 3,000-5,000 pcs per SKU depending on tube/jar and decoration.
- We can support documentation and testing (COA, SDS, micro/stability/heavy metals) and can arrange third-party testing and track reports.
- Packaging: we provide full VI and packaging matching (tube, shrink, carton), barcode support, and practical lead time guidance; mass production is commonly 25-35 days after formula/pack approval and deposit, subject to component readiness.
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.
