How to Source GMP-Certified Non-Nano Zinc Oxide for Sunscreen Formulation

For sunscreen and skincare brands, ingredient sourcing is business-critical. The wrong supplier can mean failed SPF testing, regulatory delays, or even product recalls. That’s why non-nano zinc oxide — the only single active proven to deliver true UVA and UVB protection — must come from a trusted, compliant source.

Regulatory Approval and GMP: The Foundation of Trust

The first step in sourcing is confirming that your ingredient meets the standards of leading regulators. The Australian TGA permits non-nano zinc oxide in sunscreens up to 25%, while the U.S. FDA recognises it as GRASE (Generally Recognised as Safe and Effective), with the EU maintaining strict requirements for UV filter approval. Once regulatory alignment is established, GMP (Good Manufacturing Practice) becomes the safeguard that ensures those standards are consistently met. GMP-certified production delivers reproducible SPF results, controlled purity with reduced trace metals, and full documentation for audits and approvals. Without both regulatory approval and GMP certification, brands risk compliance failures, inconsistent performance, and costly delays to market.

The 5-Step Sourcing Checklist

1. Verify TGA Approval – Confirm your supplier is licensed by the TGA for sunscreen-grade production.

2. Verify FDA and EU Compliance – Ensure their zinc oxide is FDA GRASE-approved and aligned with EU regulations.

3. Verify GMP Certification – GMP guarantees pharmaceutical-grade consistency and audit-ready documentation.

4. Assess Supply Security – Choose suppliers with large-scale capacity and global distribution networks.

5. Confirm Financial Strength – Select financially stable partners with proven long-term reliability.

Why Advance ZincTek - ZinClear® XP

Advance ZincTek manufactures GMP-certified, TGA and FDA licensed non-nano zinc oxide powder in Australia — one of the world’s most UV-intense environments.

• ZinClear® XP Powder: Trusted by formulators worldwide, fully aligned with FDA GRASE and TGA sunscreen standards.

• Scale: 5,000 MT annual manufacturing capacity, placing us among the largest global producers of non-nano zinc oxide.

• Trust: GMP-certified production ensures safety, purity, and reproducibility.

• Compliance: Regulated by FDA, TGA, and EU requirements.

The Takeaway

Sourcing non-nano zinc oxide starts with FDA and TGA compliance — and is secured through GMP. By following the sourcing checklist and partnering with a supplier that combines regulatory alignment, manufacturing capacity, and financial stability, brands can reduce formulation risks, accelerate approvals, and launch with confidence.

With industry-leading capacity and proven products like ZinClear® XP, Advance ZincTek is the trusted global partner for safe, effective, and compliant sunscreens.

 Contact Advance ZincTek today to request a sample or technical report.