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 develop OTC-style sunscreen for sensitive skin for the U.S., including mineral (zinc oxide) or hybrid options, fragrance-free and low-irritant.
- Typical starting MOQ is 1,000-3,000 units per SKU depending on the tube/bottle; lab sampling usually takes 10-14 business days after brief and target SPF are confirmed.
- For compliance support, we can arrange third-party SPF, Broad Spectrum, and Water Resistance testing, plus stability, microbiology, and packaging compatibility.
- We operate under ISO 9001:2015 quality management, and can provide documentation such as REACH-related material statements and cruelty-free/no animal testing declarations; clinical patch testing can be supported if you want “tested” positioning (no approval guarantees).
- Claims to avoid in the U.S.: “FDA approved,” “sunblock,” “100%/all-day protection,” “chemical-free,” unqualified “reef safe,” and any disease/medical claims (eczema, rosacea, melasma treatment, anti-inflammatory cures).
- After formula and artwork sign-off, typical production lead time is ~35-55 days, and we can also support packaging/VI and barcode setup for Amazon-ready launch.
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.
