At ORY®, we believe you should know what’s in your products and why. This page lists the published research behind what we say about zinc oxide. Each section starts with our claim, then tells you how well the research supports it, then lists the sources so you can read them yourself.
Important: Zinc oxide is an FDA-recognized over-the-counter (OTC) drug ingredient for sunscreens and skin protectants. ORY® products that claim sun protection (SPF) or skin protection are OTC drugs with a Drug Facts label. ORY® products that use zinc oxide only as a pigment or for oil absorption, with no sun or skin protection claims, are cosmetics and do not protect against the sun.
How to read this page Supported — backed by peer-reviewed research or official safety reviews. Supported, with caveats — the research points this way, but mostly from laboratory or animal studies, or at different strengths than ORY® uses. Limited evidence — little or no published research yet. We say so openly. |
1. General Description and Role
Claim: Zinc oxide is a white mineral powder. In ORY® OTC products it is a broad-spectrum sunscreen and a skin protectant. In ORY® cosmetics and soap it is a white pigment and helps absorb excess oil for a matte look. |
Verification: Supported. FDA permits zinc oxide as a sunscreen active at up to 25% and has proposed recognizing it as generally safe and effective. FDA also lists zinc oxide as a skin protectant active. Sun and skin protection claims make a product an OTC drug.
Citations:
- U.S. Food and Drug Administration. OTC Monograph M020 — Sunscreen drug products for over-the-counter human use (and the 2019 proposed rule, 84 Fed. Reg. 6204). https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use
- What it shows: FDA sunscreen monograph and the 2019 proposal to recognize zinc oxide as safe and effective.
- U.S. Food and Drug Administration. 21 CFR Part 347 — Skin protectant drug products for over-the-counter human use. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-347
- What it shows: FDA skin protectant rule listing zinc oxide.
- Gupta, M., Mahajan, V. K., Mehta, K. S., & Chauhan, P. S. (2014). Zinc therapy in dermatology: A review. Dermatology Research and Practice, 2014, 709152. https://doi.org/10.1155/2014/709152
- What it shows: Review of zinc compounds in dermatology.
- U.S. Food and Drug Administration. OTC Monograph M020 — Sunscreen drug products for over-the-counter human use (and the 2019 proposed rule, 84 Fed. Reg. 6204). https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use
2. Composition and Production
Claim: Zinc oxide (ZnO) is made by oxidizing zinc metal or processing zinc ores. It comes in non-nano and nano grades, and coated grades that spread more evenly. USP grade is used for OTC drug products. |
Verification: Supported. Grades and particle sizes are described in the safety literature. Reviews indicate very little zinc oxide penetrates intact skin.
Citations:
- Smijs, T. G., & Pavel, S. (2011). Titanium dioxide and zinc oxide nanoparticles in sunscreens: Focus on their safety and effectiveness. Nanotechnology, Science and Applications, 4, 95–112. https://pubmed.ncbi.nlm.nih.gov/24198489/
- What it shows: Review of nano zinc oxide safety and skin penetration.
- Smijs, T. G., & Pavel, S. (2011). Titanium dioxide and zinc oxide nanoparticles in sunscreens: Focus on their safety and effectiveness. Nanotechnology, Science and Applications, 4, 95–112. https://pubmed.ncbi.nlm.nih.gov/24198489/
3. Skin Type Suitability
Claim: Zinc oxide is gentle and suits all seven ORY® skin types. It is a common choice for sensitive skin in sunscreens and adds a matte finish for oily skin. |
Verification: Supported. Zinc oxide is well tolerated and among the least irritating sunscreen ingredients.
Citations:
- Smijs, T. G., & Pavel, S. (2011). Titanium dioxide and zinc oxide nanoparticles in sunscreens: Focus on their safety and effectiveness. Nanotechnology, Science and Applications, 4, 95–112. https://pubmed.ncbi.nlm.nih.gov/24198489/
- What it shows: Safety and tolerance review.
- Gupta, M., Mahajan, V. K., Mehta, K. S., & Chauhan, P. S. (2014). Zinc therapy in dermatology: A review. Dermatology Research and Practice, 2014, 709152. https://doi.org/10.1155/2014/709152
- What it shows: Dermatologic uses of zinc.
- Smijs, T. G., & Pavel, S. (2011). Titanium dioxide and zinc oxide nanoparticles in sunscreens: Focus on their safety and effectiveness. Nanotechnology, Science and Applications, 4, 95–112. https://pubmed.ncbi.nlm.nih.gov/24198489/
4. Hair and Scalp Suitability
Claim: In haircare, zinc oxide is used in OTC scalp sunscreen products for exposed partings. It is not a dandruff ingredient. |
Verification: Supported. Zinc oxide is not zinc pyrithione, the FDA-approved dandruff active. Scalp sun protection claims make a product an OTC sunscreen drug.
Citations:
- U.S. Food and Drug Administration. 21 CFR Part 358, Subpart H — Drug products for the control of dandruff, seborrheic dermatitis, and psoriasis. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-358/subpart-H
- What it shows: FDA dandruff actives list includes pyrithione zinc, not zinc oxide.
- U.S. Food and Drug Administration. OTC Monograph M020 — Sunscreen drug products for over-the-counter human use (and the 2019 proposed rule, 84 Fed. Reg. 6204). https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use
- What it shows: Sunscreen rules that apply to scalp SPF products.
- U.S. Food and Drug Administration. 21 CFR Part 358, Subpart H — Drug products for the control of dandruff, seborrheic dermatitis, and psoriasis. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-358/subpart-H
5. Benefits
Claim: In OTC products, zinc oxide provides broad-spectrum UVA and UVB protection and temporarily protects minor skin irritation. In cosmetics, it absorbs oil for a matte look and acts as a white pigment. |
Verification: Supported. Zinc oxide protects across UVA and UVB and is photostable. A comparison study found microfine zinc oxide gave better UVA protection than microfine titanium dioxide.
Citations:
- Pinnell, S. R., Fairhurst, D., Gillies, R., Mitchnick, M. A., & Kollias, N. (2000). Microfine zinc oxide is a superior sunscreen ingredient to microfine titanium dioxide. Dermatologic Surgery, 26(4), 309–314. https://doi.org/10.1046/j.1524-4725.2000.99237.x
- What it shows: Comparison of zinc oxide and titanium dioxide UV protection.
- Smijs, T. G., & Pavel, S. (2011). Titanium dioxide and zinc oxide nanoparticles in sunscreens: Focus on their safety and effectiveness. Nanotechnology, Science and Applications, 4, 95–112. https://pubmed.ncbi.nlm.nih.gov/24198489/
- What it shows: Review of effectiveness and safety in sunscreens.
- Pinnell, S. R., Fairhurst, D., Gillies, R., Mitchnick, M. A., & Kollias, N. (2000). Microfine zinc oxide is a superior sunscreen ingredient to microfine titanium dioxide. Dermatologic Surgery, 26(4), 309–314. https://doi.org/10.1046/j.1524-4725.2000.99237.x
6. Use Across ORY® Product Lines
Claim: Zinc oxide is used in all four ORY® product lines. Only products labeled with SPF or skin-protectant claims provide protection. |
Verification: Supported. Zinc oxide is a mineral and is stable in soap and cosmetic processing. Any SPF claim requires FDA sunscreen testing and Drug Facts labeling.
| Product line | Typical level | How ORY® uses it |
| Skincare | 5–25% (OTC sunscreen); 1–25% (OTC protectant) | Mineral sunscreens, tinted SPF, protectant creams, and clay masks (cosmetic). |
| Haircare | 5–20% (OTC scalp sunscreen) | Scalp SPF powders and sticks for exposed partings. |
| Handmade Soap | 1–3% of oil weight | White pigment for bright bars; no sun protection. |
| Cosmetics | 2–25% | Mineral foundations, powders, tinted moisturizers, and primers; SPF only when labeled as an OTC sunscreen. |
Citations:
- U.S. Food and Drug Administration. OTC Monograph M020 — Sunscreen drug products for over-the-counter human use (and the 2019 proposed rule, 84 Fed. Reg. 6204). https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use
- What it shows: Sunscreen concentration limits.
- U.S. Food and Drug Administration. 21 CFR Part 347 — Skin protectant drug products for over-the-counter human use. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-347
- What it shows: Skin protectant concentration limits.
- U.S. Food and Drug Administration. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap
- What it shows: FDA explains how soap is regulated.
- U.S. Food and Drug Administration. OTC Monograph M020 — Sunscreen drug products for over-the-counter human use (and the 2019 proposed rule, 84 Fed. Reg. 6204). https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use
7. Pros
Claim: Broad-spectrum and photostable, gentle, and useful as both a protective ingredient and a pigment. |
Verification: Supported. Supported by FDA rules and published reviews.
Citations:
- Pinnell, S. R., Fairhurst, D., Gillies, R., Mitchnick, M. A., & Kollias, N. (2000). Microfine zinc oxide is a superior sunscreen ingredient to microfine titanium dioxide. Dermatologic Surgery, 26(4), 309–314. https://doi.org/10.1046/j.1524-4725.2000.99237.x
- What it shows: UVA protection evidence.
- Smijs, T. G., & Pavel, S. (2011). Titanium dioxide and zinc oxide nanoparticles in sunscreens: Focus on their safety and effectiveness. Nanotechnology, Science and Applications, 4, 95–112. https://pubmed.ncbi.nlm.nih.gov/24198489/
- What it shows: Safety review.
- Pinnell, S. R., Fairhurst, D., Gillies, R., Mitchnick, M. A., & Kollias, N. (2000). Microfine zinc oxide is a superior sunscreen ingredient to microfine titanium dioxide. Dermatologic Surgery, 26(4), 309–314. https://doi.org/10.1046/j.1524-4725.2000.99237.x
8. Cons
Claim: Zinc oxide can leave a white cast, can feel heavy, and requires OTC drug compliance for any SPF claim. Fine powders should not be inhaled. |
Verification: Supported. We list these limits so you have the full picture:
- White cast. Especially with non-nano grades on deeper skin tones; tinted formulas help.
- Texture. Can feel heavy or drying at high levels.
- Drug rules. SPF claims require FDA testing and Drug Facts labeling.
- Inhalation. Avoid breathing in loose powders and sprays.
- Not a dandruff treatment. Zinc oxide is different from zinc pyrithione.
Citations:
- Smijs, T. G., & Pavel, S. (2011). Titanium dioxide and zinc oxide nanoparticles in sunscreens: Focus on their safety and effectiveness. Nanotechnology, Science and Applications, 4, 95–112. https://pubmed.ncbi.nlm.nih.gov/24198489/
- What it shows: Discusses particle size, cast, and inhalation considerations.
- Smijs, T. G., & Pavel, S. (2011). Titanium dioxide and zinc oxide nanoparticles in sunscreens: Focus on their safety and effectiveness. Nanotechnology, Science and Applications, 4, 95–112. https://pubmed.ncbi.nlm.nih.gov/24198489/
9. Safety Notes
Claim: Follow the Drug Facts label on OTC products and patch test cosmetics. |
Verification: Supported. The key label directions are listed below the disclaimer on this page.
Citations:
- U.S. Food and Drug Administration. OTC Monograph M020 — Sunscreen drug products for over-the-counter human use (and the 2019 proposed rule, 84 Fed. Reg. 6204). https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use
- What it shows: Source of sunscreen directions.
- U.S. Food and Drug Administration. 21 CFR Part 347 — Skin protectant drug products for over-the-counter human use. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-347
- What it shows: Source of skin protectant directions.
- U.S. Food and Drug Administration. OTC Monograph M020 — Sunscreen drug products for over-the-counter human use (and the 2019 proposed rule, 84 Fed. Reg. 6204). https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use
Before you use a zinc oxide product
- Sunscreen products (OTC): Apply liberally 15 minutes before sun exposure and reapply at least every 2 hours, or as directed on the Drug Facts label. Children under 6 months: ask a doctor.
- Skin protectant products (OTC): Follow the Drug Facts label. Stop use and ask a doctor if the condition worsens or lasts more than 7 days.
- Cosmetics and soap without SPF: These products do not protect against sunburn. Use a separate broad-spectrum sunscreen.
- Powders and sprays: Avoid breathing in loose powder or spray. Apply spray products to hands first when using on the face or scalp.
- Zinc oxide is not zinc pyrithione. ORY® zinc oxide products are not dandruff treatments.
10. References
Peer-reviewed research
- Gupta, M., Mahajan, V. K., Mehta, K. S., & Chauhan, P. S. (2014). Zinc therapy in dermatology: A review. Dermatology Research and Practice, 2014, 709152. https://doi.org/10.1155/2014/709152
- Pinnell, S. R., Fairhurst, D., Gillies, R., Mitchnick, M. A., & Kollias, N. (2000). Microfine zinc oxide is a superior sunscreen ingredient to microfine titanium dioxide. Dermatologic Surgery, 26(4), 309–314. https://doi.org/10.1046/j.1524-4725.2000.99237.x
- Smijs, T. G., & Pavel, S. (2011). Titanium dioxide and zinc oxide nanoparticles in sunscreens: Focus on their safety and effectiveness. Nanotechnology, Science and Applications, 4, 95–112. https://pubmed.ncbi.nlm.nih.gov/24198489/
Government and regulatory sources
- U.S. Food and Drug Administration. OTC Monograph M020 — Sunscreen drug products for over-the-counter human use (and the 2019 proposed rule, 84 Fed. Reg. 6204). https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use
- U.S. Food and Drug Administration. 21 CFR Part 347 — Skin protectant drug products for over-the-counter human use. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-347
- U.S. Food and Drug Administration. 21 CFR Part 358, Subpart H — Drug products for the control of dandruff, seborrheic dermatitis, and psoriasis. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-358/subpart-H
- U.S. Food and Drug Administration. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap
