Sunscreen
Global Sunscreen OEM/ODM: cGMP Compliant & FDA-Registered Manufacturing Partner
Expert Sunscreen Manufacturing for Global Brands
Your FDA-Inspected, cGMP-Certified Partner in Global Sunscreen Manufacturing.
As a cGMP-certified facility that has successfully passed FDA on-site audits, we provide a full-service, turnkey solution for global brands seeking excellence in sunscreen products. Our seamless process covers every stage: Formulation R&D, Regulatory Compliance & Registration, and Full-Scale Production & Delivery.
With 20 years of specialized experience in the sun care sector, we have developed a portfolio of over 160 proprietary sunscreen formulas and have proudly served clients in 37 countries. Our expertise spans the complete range of product forms, including:
- Sprays
- Lotions
- Creams
- Gels
- Sticks
- Oils
Our state-of-the-art facility has a monthly production capacity of 4.5 million units. We also champion the growth of new and emerging brands by offering flexible manufacturing with a low Minimum Order Quantity (MOQ) starting at just 5,000 units. This approach empowers you to enter the global market with innovative products while minimizing inventory risk.
The Special Regulatory Status of Sunscreen Products
In the United States market, sunscreen products are strictly classified as over-the-counter (OTC) drugs, not as standard cosmetics. They are required to comply with the regulations outlined in the OTC Monograph M020 and the Final Rule for sunscreens under 21 CFR Part 352. Products that have not completed their National Drug Code (NDC) registration are subject to customs detention or receipt of a Warning Letter.
Key requirements include:
- Active Ingredient Restrictions: Only the use of FDA-approved UV filters is permitted.
- SPF Value Verification: SPF claims must be validated through in-vivo human testing as specified by the FDA under 21 CFR § 201.327.
- Labeling Regulations: The use of a “Drug Facts” panel on the label is mandatory.
- GMP Requirements: Manufacturing facilities must comply with the Current Good Manufacturing Practice (cGMP) regulations for drugs as detailed in 21 CFR Parts 210 and 211.
Our End-to-End Compliance Services
To address the core challenges of bringing sunscreen products to the U.S. market, we provide a full-process solution:
1. OTC Monograph Pre-Compliance Review
- Formula Audit: Ensures active ingredient combinations and concentrations comply with the FDA Monograph (e.g., Zinc Oxide ≤ 25%).
- Label & Claims Review: Prevents the use of unsubstantiated claims, such as unverified “80-minute water resistance” statements.
- Toxicological Risk Assessment (TRA)
- Active Ingredient Assay (Potency Test)
- USP <51> Antimicrobial Effectiveness Test
- USP <61> & <62> Microbiological Examination of Nonsterile Products
- In-Vivo SPF（UVB） Efficacy and In-Vitro PA(UVA）Testing
- Additional Chemical Testing: Heavy Metals (Lead, Cadmium, Mercury), 1,4-Dioxane, and Water Activity.
- Hypoallergenic Testing
2. NDC Number Application & OTC Drug Listing
We obtain your NDC code in an average of 15 days, compared to the 45-day industry average.
3. Optimized Testing Programs
We coordinate with FDA-recognized, GMP-qualified testing laboratories.
We offer integrated testing packages for SPF, Broad-Spectrum, and Water Resistance claims.
This approach can reduce redundant testing costs by 30%.
4. GMP Compliance Support
Our facility design and operational protocols are fully compliant with pharmaceutical cGMP requirements (21 CFR 210/211).
Lab Test Data of 6 Sun Care Formats
Visual Data: Usage Scenarios & Format Preferences
Outdoor Sports
- Spray Usage Rate: 72%
- Stick Usage Rate: 18%
Daily Commute
- Lotion Usage Rate: 45%
- Cream Usage Rate: 30%
Water Activities
- Cream Usage Rate: 65%
- Gel Usage Rate: 25%
Kids Care
- Mousse Usage Rate: 58%
- Spray usage rate 35%
