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 US OTC sunscreen, your label must include a Drug Facts panel listing active ingredients (avobenzone, oxybenzone, etc.) with concentration percentages, SPF value, water resistance claims (40/80 minutes), and usage directions.
- We’ll provide template-compliant labeling during sampling phase.
- MOQ starts at 5,000 units per SKU, with 4-6 weeks for regulatory review and testing documentation.
- Final packaging requires FDA registration number and batch code traceability.
- Lead time is 8-12 weeks post-approval, with 2-3 weeks for label artwork verification.
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.