Zinc Oxide, Non - Nano, USP Grade

Non-nano Zinc Oxide USP sold by the ounce, so you can purchase exactly what your formulation requires. This batch is sourced from Shay and Company and is 100 percent pure zinc oxide, 325 mesh, pharmaceutical grade (USP).

. It forms a protective physical barrier on the skin and is commonly included in formulations designed for moisture-prone or irritated areas.

This material is non-nano, meaning it is not engineered at nanoscale particle size.

Sun Protection Use
Under the FDA Over-the-Counter Monograph M020 (September 24, 2021), zinc oxide and titanium dioxide are the only mineral active ingredients permitted in OTC sunscreen drug products. Zinc oxide may be used at concentrations up to 25 percent.

General formulation reference:

• ~1 percent zinc oxide by weight corresponds to roughly 1.5 SPF
• ~10 percent zinc oxide corresponds to roughly 15 SPF
• ~20 percent zinc oxide corresponds to roughly 30 SPF

These figures are theoretical estimates only. Actual SPF can only be determined through laboratory testing of the finished product. Products intended for retail sale as sunscreens must meet FDA compliance and testing requirements.

Why It Matters
Certain organic UV filters, including oxybenzone and octinoxate, have been restricted in some coastal regions due to concerns about coral reef ecosystems and aquatic toxicity. Zinc oxide is a mineral UV filter and remains permitted under current FDA sunscreen regulations. It works by physically reflecting and scattering UV radiation rather than absorbing it through a chemical reaction.

For formulators seeking a mineral-based active ingredient with a long history of topical use, non-nano zinc oxide offers a straightforward alternative within current regulatory frameworks. Environmental impact depends on formulation, concentration, and usage patterns.

Formulation Notes
Zinc oxide can be dispersed into the warmed oil phase of a formulation or incorporated during cool down while actively blending. Thorough dispersion supports uniform coverage and performance.

Handling & Safety
This is a fine mineral powder. Avoid inhalation during handling. Mix slowly to reduce airborne dust and consider wearing a mask when working with dry powders. For external use in finished formulations only.

INCI: Zinc Oxide
CAS: 1314-13-2
Grade: USP (pharmaceutical grade)
Mesh Size: 325, non-nano
Country of Origin: Canada or Peru (lot dependent)
Solubility: Dispersible in oil and water systems
Extraction Method: Vaporized metallic zinc oxidized in an oxidation chamber
Composition: 100% Zinc Oxide
Vegan: Yes
Gluten Free: Yes
Allergen: None known