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.
- Shelf life is established by conducting stability testing under controlled conditions, typically involving accelerated testing (e.g., 40°C/75% RH for 3-6 months) and real-time testing (e.g., 25°C/60% RH for 12-24 months).
- This evaluates product changes in appearance, pH, viscosity, and microbial count over time.
- Evidence comes from lab reports and data logs that track these parameters, ensuring they remain within specified limits.
- For US markets, we align with FDA guidelines and USP standards, though final regulatory approval depends on your brand’s submission.
- We support by performing tests in-house or through partnered labs and compiling documentation like stability study protocols and reports.
- Key details include MOQ considerations—higher MOQs may allow dedicated stability batches, reducing per-unit cost.
- Sampling timeline for stability studies adds 3-6 months to development, impacting overall lead time.
- Packaging choices, such as airless pumps or opaque bottles, can extend shelf life by preventing oxidation or light exposure.
- We recommend factoring in testing early to avoid delays and ensure robust evidence for shelf life claims.
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.