Sunkool Lotion is a stabilized sunscreen formulation engineered for pharmaceutical precision, combining broad-spectrum UV filters with emollients to ensure efficacy and user compliance. The SPF-30+ rating is achieved through a proprietary blend of organic and inorganic sunscreens, including avobenzone and zinc oxide, which provide balanced UVA/UVB protection. The formulation employs a water-in-oil emulsion system to enhance skin adhesion and durability, while preservatives and pH regulators ensure microbial stability and compatibility with pharmaceutical-grade excipients. The product’s low viscosity and non-greasy texture are optimized for industrial production, ensuring uniform dispersion during manufacturing. From a formulation perspective, Sunkool Lotion adheres to pharmaceutical standards for safety, consistency, and shelf-life stability, with a focus on minimizing degradation under thermal and photolytic stress. The inclusion of emollients such as glycerin and dimethicone improves sensory attributes without compromising the active ingredient’s photostability, making it suitable for large-scale production.
Manufacturing Capability
Our pharmaceutical manufacturing infrastructure is designed to meet the demands of high-volume production while maintaining strict adherence to GMP standards. The facility is equipped with advanced processing units, including high-speed mixers, homogenizers, and vacuum distillation systems, enabling precise control over emulsion stability and active ingredient dispersion. Sterile processing capabilities are integrated for sunscreen formulations, with dedicated cleanrooms classified at ISO 7 and ISO 8 standards to prevent contamination. Production scalability is ensured through modular manufacturing lines that can accommodate batch sizes from 1,000 to 100,000 liters, with real-time monitoring systems for temperature, pH, and viscosity. Quality systems include automated documentation, traceability protocols, and continuous validation of critical process parameters. The facility’s infrastructure also supports the integration of API sourcing, formulation development, and packaging solutions, ensuring end-to-end compliance for pharmaceutical-grade products.
Available Strengths and Packaging
Composition: Sunscreen Lotion SPF-30+
Packaging: 60ml
Sunkool Lotion is available in a single strength formulation (SPF-30+) to meet standardized dermatological requirements. The 60ml packaging is designed for commercial distribution, utilizing HDPE (high-density polyethylene) bottles with tamper-evident closures to ensure product integrity during storage and transport. The packaging is optimized for stability under varying climatic conditions, with UV-resistant materials to preserve the active ingredients’ efficacy.
Contract Manufacturing / Third Party Manufacturing
As a trusted manufacturer, we offer end-to-end contract manufacturing services tailored to pharmaceutical buyers’ needs. Our capabilities include private label manufacturing, where we produce branded formulations under a client’s trademark, as well as contract manufacturing for OEM and ODM applications. We support the development of customized sunscreen formulations, from API sourcing to final packaging, ensuring compliance with global regulatory standards. Our team collaborates with clients to optimize formulation parameters, such as SPF levels, texture, and shelf-life, while maintaining cost-efficiency and scalability. For third-party manufacturers, we provide turnkey solutions that include raw material procurement, quality control, and regulatory documentation, enabling clients to enter new markets with minimal overhead.
Quality Assurance
Our quality assurance framework is built on rigorous analytical validation, batch testing, and compliance with pharmaceutical standards. Each production batch undergoes in-process testing for pH, viscosity, and active ingredient concentration, with final testing conducted via HPLC (high-performance liquid chromatography) to quantify sunscreen components. Microbial and sterility testing are performed in accordance with USP and EP guidelines, ensuring product safety for dermatological use. Analytical validation includes stability testing under accelerated conditions (40°C, 75% RH) to confirm shelf-life claims. All quality control data is documented in electronic systems compliant with 21 CFR Part 11, ensuring transparency and traceability for regulatory audits.
Regulatory Compliance
Sunkool Lotion is manufactured in full compliance with GMP, WHO guidelines, and ISO 9001/14001 standards. The production process adheres to ICH Q7 and Q8 guidelines for pharmaceutical manufacturing, with documentation and validation protocols aligned with FDA, EMA, and WHO requirements. Our facility holds certifications for ISO 9001 (quality management) and ISO 14001 (environmental management), ensuring sustainable practices throughout the supply chain. Regulatory compliance extends to labeling, packaging, and export documentation, with support for market-specific requirements such as FDA registration, EMA compliance, and ASEAN regulatory frameworks.
Global Supply Capability
We provide robust global supply capabilities, including export-ready packaging, international distribution networks, and bulk supply solutions. Our logistics partners ensure seamless delivery to over 50 countries, with temperature-controlled storage and shipping options for sensitive formulations. Bulk supply capacity ranges from 10,000 to 500,000 liters per month, supported by a scalable supply chain with contingency planning for disruptions. The facility’s strategic location and partnerships with global freight providers enable rapid response to market demands, ensuring on-time delivery and compliance with import regulations.
Why Choose Us
Pharmaceutical distributors, exporters, and contract manufacturing partners benefit from our expertise in scalable, compliant production. Our experience in manufacturing pharmaceutical-grade sunscreens ensures consistent quality and regulatory alignment, while our flexible services cater to diverse market needs. We offer tailored solutions, from formulation development to global distribution, supported by a dedicated team with expertise in GMP, ISO, and regulatory compliance. Our commitment to innovation, sustainability, and customer support positions us as a reliable partner for businesses seeking to expand their product portfolios.
Bulk Supply Inquiry
We offer bulk supply capabilities for Sunkool Lotion, with production flexibility to meet large-scale demand. For inquiries regarding bulk orders, please contact:
info@delwishealthcare.com
FAQs
What certifications does your manufacturing facility hold?
Our facility is certified under GMP, ISO 9001, and ISO 14001, ensuring compliance with global pharmaceutical standards.
Can you customize the SPF level for sunscreen formulations?
Yes, we offer tailored SPF levels (e.g., SPF-30+, SPF-50+) based on client specifications and regulatory requirements.
What packaging options are available for bulk supply?
We provide 60ml HDPE bottles with tamper-evident closures, as well as bulk drums and intermediate bulk containers (IBCs) for large-scale distribution.
Do you support private label manufacturing?
Yes, we offer private label manufacturing services, including formulation development, packaging, and branding under your trademark.
What regulatory standards do you follow for sunscreen products?
We comply with FDA, EMA, WHO, and ASEAN guidelines, with documentation for global market entry.
How do you ensure product stability during storage?
Our formulations are tested for stability under accelerated conditions (40°C, 75% RH), with packaging designed for UV resistance and temperature control.
Can you provide samples for quality testing?
Yes, we offer small-scale samples for analytical validation and regulatory testing prior to bulk orders.
What is your minimum order quantity for bulk supply?
Our minimum order quantity is 10,000 liters, with flexibility for smaller orders based on client requirements.
How do you handle supply chain disruptions?
We maintain a diversified supply chain with backup suppliers and logistics partners to ensure uninterrupted delivery.
Do you support contract manufacturing for international markets?
Yes, our contract manufacturing services include compliance with regional regulations, enabling seamless market entry for global clients.
