§609 Labeling and Responsible Person Details
Cosmetic labels must show the responsible person’s name and contact in the United States and will soon need fragrance allergen disclosures once FDA finalizes the list.
Key obligations
- Display the responsible person contact (address, phone, or electronic contact) on every label.
- Control artwork changes through a documented review and approval process.
- Track fragrance allergens and prepare to update labels once FDA publishes the list.
- Flag professional-use products and make sure labels carry required statements.
Evidence regulators expect to see
- Artwork masters with version history and sign-offs.
- Label review checklist proving regulatory, quality, and marketing approvals.
- Allergen tracking register tied to formulas and artwork updates.
- Claim substantiation files linked to marketing statements on-pack.
Intake sections that populate this section
Relevant SOP templates
Risk of non-compliance
- Misbranding citations and product holds if labels omit required contact details.
- Costly rework when allergen disclosures or claims lack documentation.
- Retailer compliance penalties for inaccurate or outdated labels.
Further reading
Use these notes to brief leadership and justify remediation work. As you complete the intake, the Generate Package step merges your answers into each SOP so you can demonstrate compliance with §609 Labeling and Responsible Person Details.