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.
- Yes, we can support both “ophthalmologist-tested” and “sensitive-skin” positioning, but in the US you will need claim substantiation (test reports, protocol, and controlled wording) rather than just manufacturing certificates.
- We can help you choose compliant claim language for Amazon/FTC risk control and build a documentation folder.
- Evidence typically includes: (1) ophthalmologist-supervised safety/tolerability study for the eye area (in-use evaluation plus adverse event tracking), and (2) sensitive-skin support such as irritation testing and/or patch-style tolerability testing.
- We operate specialized labs including irritation and efficacy testing, and we can coordinate clinical testing through qualified medical/skin research partners.
- We can also provide supporting factory documents such as ISO 9001:2015, REACH-related compliance information, and cruelty-free/no animal testing statements.
- Execution guidance: MOQ is typically 3,000 to 10,000 pcs per SKU depending on formula and packaging.
- Lab samples can usually be ready in 7 to 14 days after brief confirmation; clinical testing timing depends on the protocol you select.
- Packaging and VI design support is available, and bulk production lead time is commonly 30 to 45 days after formula, artwork, and components are finalized.
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.