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Can you support ophthalmologist-tested and sensitive-skin positioning (what evidence is needed)?

Yes. For US positioning like "ophthalmologist-tested" and "sensitive-skin" we can support the required substantiation via third-party clinical/tolerability testing and a documentation pack (without promising any regulatory outcome).

US buyer view Launch planning Updated: January 27, 2026
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Best for
US brand owners, Amazon/FBA sellers, distributors, and private label buyers
Core intent
Who submits, what data is needed, and how to plan timelines before production

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.
⚠️
This page is a practical buyer guide. For definitive requirements and updates, use FDA resources and qualified regulatory counsel.
  • Our team will answer your inquiries within 8 hours.
  • Your information will be kept strictly confidential.

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