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.
- To support ‘dermatologist tested’ claims on baby care products, we arrange testing through ISO 17025 accredited labs such as SGS or Intertek.
- The standard protocol involves patch testing on 50+ volunteers (including infants) over 4 weeks, with dermatologist oversight.
- Testing costs typically add $3,000-$5,000 per SKU, requiring 6-8 weeks post-formulation lock.
- We provide full documentation including test reports, methodology, and dermatologist certifications.
- For US market compliance, we ensure protocols align with CTFA guidelines and FDA cosmetic labeling requirements.
- Testing must be completed before production, adding 2-3 weeks to your timeline.
- MOQ for testing batches is 500 units per SKU.
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.