Facility registration is non-negotiable
Every facility that manufactures or processes cosmetic products for the US market must be registered with FDA, and the registration must be renewed every two years. As your contract manufacturer, SkinCore Labs handles facility registration on our side — but you are responsible for confirming we are listed as your manufacturer in your product filings.
If you also do any finishing, kitting or repackaging at your own facility (relabeling, gift-set assembly), that facility must register separately.
Product listings are due before market launch
Every cosmetic product distributed in the US requires a product listing submitted to FDA. The listing includes brand and product name, applicable cosmetic category, ingredient list (including fragrance allergens above threshold), and the responsible person.
New products require a listing within 120 days of first marketing. Existing products that materially change formula or label require an updated listing.
Adverse event reporting now has teeth
The 'responsible person' on a product label must collect and retain adverse-event reports for six years (three years for small businesses) and report serious adverse events to FDA within 15 business days. Build the intake workflow before launch — not after your first complaint.
- Add an adverse-event email and phone line to your contact page
- Train customer support on the FDA's 'serious adverse event' definition
- Maintain records for six years, even after a SKU is discontinued
Label updates you should plan for in 2026
FDA's labeling final rule for fragrance allergens lands in 2026, with a multi-year compliance runway. Plan label updates for any product that contains fragrance allergens above the listed threshold — this affects almost every leave-on product with parfum.
Domestic addresses for adverse-event reporting must appear on the label. A PO box is acceptable; an international-only address is not.
What we handle vs what you must own
SkinCore Labs maintains facility registration, GMP records, batch records and ingredient documentation. You — as the brand owner / responsible person — own product listing, claim substantiation, marketing-facing labels and adverse-event response. Get this division in writing in your manufacturing services agreement.
Key takeaways
- Confirm your contract manufacturer is registered and listed in your product filings before launch.
- Submit product listings within 120 days of first sale; refresh on material formula or label changes.
- Stand up an adverse-event intake and 15-day reporting workflow before you ship the first unit.
- Refresh labels for fragrance allergens and US contact information ahead of the 2026 enforcement window.