Compliance & Safety
We hold ourselves to the highest regulatory and quality standards so you can confidently sell products under your brand.
FDA Cosmetic Labeling
All JuveRX products comply with FDA cosmetic labeling requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Every product label includes the complete INCI ingredient list, net weight/volume, manufacturer name and address, appropriate warnings, and directions for use. We maintain current knowledge of FDA guidance documents and ensure all labeling claims are substantiated and compliant. Products are marketed as cosmetics and do not make drug claims unless properly registered as OTC drugs.
INCI Standards
All ingredient lists follow the International Nomenclature of Cosmetic Ingredients (INCI) naming convention as required by the FDA and aligned with the Personal Care Products Council dictionary. Ingredients are listed in descending order of concentration, with ingredients at 1% or below listed in any order. All INCI names are verified against the current edition of the INCI dictionary to ensure accuracy and compliance with international cosmetic regulations.
Product Liability Insurance
JuveRX maintains comprehensive product liability insurance coverage of $1M-$2M, secured before the first product sale. This coverage protects both the company and our practitioner partners against claims related to product use. We work with insurance carriers experienced in cosmetic and personal care product coverage. Certificates of insurance are available upon request for practitioners who need documentation for their own business insurance requirements.
Certificates of Analysis & Safety Data Sheets
Certificates of Analysis (COA) and Safety Data Sheets (SDS) are maintained for all products and raw materials. COAs document batch-specific testing results including identity, purity, potency, and microbiological testing where applicable. SDS documents provide hazard identification, handling procedures, first aid measures, and disposal information as required by OSHA. All documentation is available to practitioners upon request and maintained in our digital archive.
OTC Sunscreen Compliance
Our SPF products are sourced exclusively from FDA-registered, OTC-compliant manufacturers. These products comply with the FDA OTC Sunscreen Monograph, including proper Drug Facts panel labeling, approved active ingredient concentrations (zinc oxide, titanium dioxide), required testing for SPF value and broad-spectrum protection, and all mandated warnings and directions.
TCPA Compliance
All marketing communications, including text messages, phone calls, and emails, comply with the Telephone Consumer Protection Act (TCPA) and CAN-SPAM Act. We maintain proper consent records for all contacts, include opt-out mechanisms in every message, honor all opt-out requests promptly, and use compliant SMS platforms. Our outreach practices are reviewed regularly to ensure continued compliance with evolving telecommunications regulations.
Quality Control & Batch Records
Every production run is documented with comprehensive batch records including date of production, product name, formulation version, ingredient lot numbers and quantities, pH readings, visual inspection notes, and producer identification. AI-generated batch record templates ensure consistency and completeness. All raw ingredients are sourced from pharmaceutical and cosmetic-grade suppliers with verified quality certifications. This documentation supports traceability and quality assurance across our entire product line.
Have Compliance Questions?
Our team is available to discuss regulatory requirements, provide documentation, or answer any questions about product safety and compliance.