Sunscreen

We make it easy for you to build your brand by providing a one-stop solution for your private-label OEM/ODM production.

Over-The-Counter (OTC) Sunscreen

Compliance Declaration: Strictly adheres to FDA OTC Monograph M020 formulation standards.

As a cGMP-certified facility with on-site FDA audit clearance, we provide global skincare brands with a one-stop, end-to-end sunscreen solution: from formula R&D and regulatory registration to mass production and delivery.


With over 20 years of deep expertise in UV protection, we have developed 160+ proprietary sunscreen formulas and serve clients across 37 countries. Our manufacturing capabilities cover all formats—sprays, lotions, creams, gels, and sticks—with a monthly capacity of 4.5 million units. We support a highly flexible supply chain starting at an MOQ of just 10,000 units, empowering indie and emerging brands to penetrate the U.S. market with minimal inventory risk.

The Unique Regulatory Status of Sun Care

Products in the U.S.
In the United States, sunscreens are strictly regulated as Over-The-Counter (OTC) Drugs, not standard cosmetics. They must comply with the FDA OTC Monograph M020 (21 CFR 352). Products failing to secure an NDC (National Drug Code) face immediate customs detention or FDA Warning Letters. Our formulations guarantee compliance across all critical pillars:

  • Active Ingredient Restrictions: Utilizing only the 16 UV filters officially approved by the FDA.
  • SPF Validation: Mandatory human clinical testing compliant with FDA 21 CFR 201.327.
    Labeling
  • Compliance: Strict adherence to the mandatory “Drug Facts” panel layout.
  • cGMP Requirements: Production facilities strictly meet 21 CFR 210/211 pharmaceutical manufacturing standards.

Our Full-Cycle Regulatory Compliance Services

We eliminate the hurdles of entering the U.S. sunscreen market with a comprehensive regulatory package:
1. OTC Monograph Conformity Pre-Audit
  1. Formula Audit: Validating active ingredient combinations and concentrations against FDA monographs (e.g., Zinc Oxide ≤ 25%).
  2. Label & Claim Audit: Verifying marketing claims like “80-Minute Water Resistance” and ensuring structural label compliance.
  3. TRA (Toxicological Risk Assessment).
  4. Active Ingredient Assay Testing.
  5. USP <51> Antimicrobial Effectiveness Testing (AET).
  6. USP <61> & <62> Microbiological Examination.
  7. Human Clinical SPF & Broad-Spectrum Efficacy Testing.
  8. Chemical Purity Testing: Heavy metals (Pb, Cd, Hg), 1,4-Dioxane, and Water Activity.
  9. Hypoallergenic (HRIPT) Testing.
2. Accelerated NDC Code Application & OTC Listing

We secure NDC codes in an average of 5 days (compared to the industry average of 15 days).

3. Optimized Testing Protocols

Direct partnerships with FDA-recognized, cGMP-certified testing laboratories.
All-in-one testing packages (SPF / Broad-Spectrum / Water Resistance), reducing your total testing costs by 30%.

4. cGMP Compliance Support

Facility and cleanroom designs explicitly engineered to meet pharmaceutical GMP requirements.

Ultra-Lightweight Broad-Spectrum Sunscreen Lotion SPF 50+ PA++++

Core Efficacies:

  • Broad-Spectrum UV Defense
  • Photo-Damage Repair
  • Ultra-Lightweight Hydration
  • Non-Comedogenic
  • Safe & Gentle

Texture: An airy, cloud-like lotion that forms an invisible, skin-mimicking film upon application. Refreshing, non-sticky, completely non-comedogenic (won’t clog pores), and applies flawlessly without pilling under makeup.

Core Active Ingredients

FDA-Compliant UV Filter Matrix

Homosalate, Ethylhexyl Methoxycinnamate (Octinoxate), Ethylhexyl Salicylate (Octisalate), Phenylbenzimidazole Sulfonic Acid (Ensulizole), Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine (Bemotrizinol), Benzophenone-3 (Oxybenzone).

Tocopheryl Acetate (Vitamin E), Simmondsia Chinensis (Jojoba) Seed Oil, Cocos Nucifera (Coconut) Oil, Ectoin (Tetrahydropyrimidine Carboxylic Acid), Pro-Xylane (Hydroxypropyl Tetrahydropyrantriol), Centella Asiatica (Cica) Extract.

Formulation Advantages & Biological Pathways

1. GRASE (Generally Recognized As Safe and Effective) Compliance

Every UV active in this formulation strictly aligns with the FDA’s approved list of 16 suncare actives and falls within perfectly safe, permitted concentration limits. This guarantees the formula is globally recognized as safe and effective under current regulatory frameworks.

2. The 6-Filter Chemical Matrix: Broad-Spectrum UVA/UVB Shield

Mechanism: Our synergistic 6-filter matrix absorbs high-energy UV photons and converts them into harmless thermal energy (heat), preventing structural DNA damage to the skin. Operating within the FDA monograph framework, this matrix guarantees comprehensive broad-spectrum coverage against UVB (280-315nm) and UVA rays, intercepting 99% of harmful radiation before it penetrates the epidermis.

3. Antioxidant Repair: Neutralizing Free Radicals

Mechanism: When organic UV filters convert light into heat, trace amounts of free radicals can be generated. We offset this by infusing potent antioxidants (Vitamin E) and cellular repair agents (Ectoin, Pro-Xylane, and Cica). These actives instantly neutralize free radicals, reduce oxidative stress, and reverse the micro-damage that leads to photo-aging. It’s not just sunscreen; it’s active anti-aging repair.

4. Flawless Film-Formation & Hydration

Mechanism: Premium botanical bases (Jojoba and Coconut Oil) provide exceptional spreadability. This lipid base expertly dissolves the UV actives, ensuring they form a perfectly uniform, unbroken film across the skin’s micro-texture. This uniform film is the scientific key to ensuring the real-world SPF precisely matches the clinically tested SPF.

 

(Regulatory Edge: We actively track FDA administrative orders—including upcoming M020 monograph and active ingredient revisions scheduled for Oct 2025 and June 2026—ensuring your formulations remain future-proof and compliant).

📊 Visualized Data: Format Performance & Market Preferences

(Empowering your B2B purchasing decisions with empirical market data)

Table 1: Lab Performance Data of 5 Key Suncare Formats

Performance Metric Spray Lotion (This Product) Cream Gel Stick
SPF 50 Film-Formation Time 38 Sec 72 Sec 85 Sec 45 Sec 20 Sec
Lightweight Texture Score ★★★★☆ ★★★★★ ★★★☆☆ ★★★★☆ ★★★☆☆
Water Resistance 40 Min 80 Min 80 Min 40 Min 80 Min

(Data Source: Internal cGMP Laboratory Testing Reports)

Usage Scenarios & Consumer Format Preferences

Understanding consumer behavior to optimize your product line:

1. Outdoor Sports & Athletics

  • Aerosol Sprays: 72%
  • Sunscreen Sticks: 18%

2. Daily Commute / Under Makeup

  • Lotions: 45% (Highest Demand)
  • Creams: 30%

3. Water Activities / Beach

  • Heavy Creams: 65%
  • Gels: 25%

4. Pediatric / Kids Care

  • Aerosol Sprays: 35%