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 benzophenone-4 (sulisobenzone). 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.
Please note: Benzophenone-4 is also an FDA-permitted sunscreen drug ingredient. ORY® uses it at low levels to protect the color, scent, and botanicals in our products from light. Products that use it this way are not sunscreens and do not protect your skin from the sun. Only products with a Drug Facts label and an SPF value are sunscreens.
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: Benzophenone-4 (sulisobenzone) is a water-soluble ingredient that absorbs ultraviolet (UV) light. In ORY® products, it is used at low levels to keep product colors, fragrances, and botanicals from fading or breaking down in light, and to help protect hair color from fading. |
Verification: Supported. The Cosmetic Ingredient Review (CIR) Expert Panel concluded in its 2021 amended report that benzophenone-4 is safe in cosmetics in the present practices of use and concentration (highest reported use about 1.6%).
Citations:
- Cosmetic Ingredient Review. (2021). Amended safety assessment of benzophenones as used in cosmetics (final report). https://www.cir-safety.org/sites/default/files/benzop032021FAR.pdf
- What it shows: CIR amended safety assessment of benzophenones.
- Elder, R. L. (Ed.). (1983). Final report on the safety assessment of benzophenones-1, -3, -4, -5, -9, and -11. Journal of the American College of Toxicology, 2(5), 35–77. https://doi.org/10.3109/10915818309140714
- What it shows: Original CIR assessment.
- Cosmetic Ingredient Review. (2021). Amended safety assessment of benzophenones as used in cosmetics (final report). https://www.cir-safety.org/sites/default/files/benzop032021FAR.pdf
2. Composition and Production
Claim: Benzophenone-4 is made by adding a sulfonic acid group to benzophenone-3 (oxybenzone), which makes it water-soluble. It absorbs UVB and short-wave UVA light. |
Verification: Supported. Its chemistry is well documented. FDA permits sulisobenzone up to 10% as an over-the-counter sunscreen active; in its 2019 proposed rule, FDA asked for more safety data on it. The widely reported absorption study of sunscreen actives tested oxybenzone and other filters, not benzophenone-4.
Citations:
- Cosmetic Ingredient Review. (2021). Amended safety assessment of benzophenones as used in cosmetics (final report). https://www.cir-safety.org/sites/default/files/benzop032021FAR.pdf
- What it shows: Describes chemistry.
- U.S. Food and Drug Administration. OTC Monograph M020 — Sunscreen drug products for over-the-counter human use (deemed final order), including sulisobenzone up to 10%. https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse09242021.pdf
- What it shows: FDA sunscreen monograph.
- U.S. Food and Drug Administration. (2019, February 26). Sunscreen drug products for over-the-counter human use (proposed rule), 84 FR 6204. https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use
- What it shows: FDA 2019 proposed rule.
- Matta, M. K., et al. (2019). Effect of sunscreen application under maximal use conditions on plasma concentration of sunscreen active ingredients: A randomized clinical trial. JAMA, 321(21), 2082–2091. https://doi.org/10.1001/jama.2019.5586
- What it shows: Absorption study (did not include benzophenone-4).
- Cosmetic Ingredient Review. (2021). Amended safety assessment of benzophenones as used in cosmetics (final report). https://www.cir-safety.org/sites/default/files/benzop032021FAR.pdf
3. Skin Type Suitability
Claim: At the low levels ORY® uses, benzophenone-4 protects the product and suits most skin types. People with benzophenone allergy should avoid it. |
Verification: Supported, with caveats. In a large North American patch-test study, about 1.6% of patients tested had a positive reaction to benzophenone-4, most of them relevant to their dermatitis.
Citations:
- Warshaw, E. M., et al. (2023). Patch testing with benzophenone-3 and -4: The North American Contact Dermatitis Group experience, 2013–2020. Dermatitis, 34(2), 105–112. https://doi.org/10.1089/derm.2022.29013.ewa
- What it shows: Patch-test study of benzophenone-4 allergy.
- Warshaw, E. M., et al. (2023). Patch testing with benzophenone-3 and -4: The North American Contact Dermatitis Group experience, 2013–2020. Dermatitis, 34(2), 105–112. https://doi.org/10.1089/derm.2022.29013.ewa
4. Hair and Scalp Suitability
Claim: In haircare, benzophenone-4 helps protect hair color from fading caused by light. |
Verification: Supported, with caveats. Protecting hair color is a cosmetic claim. Products that claim to protect the skin or scalp from sunburn are sunscreen drugs, and ORY® haircare products do not make that claim.
Citations:
- Cosmetic Ingredient Review. (2021). Amended safety assessment of benzophenones as used in cosmetics (final report). https://www.cir-safety.org/sites/default/files/benzop032021FAR.pdf
- What it shows: Reported hair-care uses.
- U.S. Food and Drug Administration. (2019, February 26). Sunscreen drug products for over-the-counter human use (proposed rule), 84 FR 6204. https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use
- What it shows: FDA regulates sun-protection claims for skin as sunscreen drugs.
- Cosmetic Ingredient Review. (2021). Amended safety assessment of benzophenones as used in cosmetics (final report). https://www.cir-safety.org/sites/default/files/benzop032021FAR.pdf
5. Benefits
Claim: Benzophenone-4 helps keep ORY® products looking and smelling as intended and helps protect hair color from fading. |
Verification: Supported. Absorbing UV light to protect a product is a well-established cosmetic function. These are benefits to the product and hair color, not sun protection for your skin.
Citations:
- Cosmetic Ingredient Review. (2021). Amended safety assessment of benzophenones as used in cosmetics (final report). https://www.cir-safety.org/sites/default/files/benzop032021FAR.pdf
- What it shows: Describes function.
- Cosmetic Ingredient Review. (2021). Amended safety assessment of benzophenones as used in cosmetics (final report). https://www.cir-safety.org/sites/default/files/benzop032021FAR.pdf
6. Use Across ORY® Product Lines
Claim: Benzophenone-4 is used at low levels in all four ORY® product lines. |
Verification: Supported. Use levels are well below the highest concentration CIR reviewed. ORY® does not make SPF or sun-protection claims unless a product is made and labeled as an OTC sunscreen.
| Product line | Typical level | How ORY® uses it |
| Skincare | 0.05–0.5% | Clear toners, gels, mists, and serums (product protection only). |
| Haircare | 0.1–0.5% | Color-protect shampoos, conditioners, and leave-in sprays. |
| Handmade Soap | 0.1–0.3% | Clear and colored bars, to reduce fading. |
| Cosmetics | 0.05–0.5% | Setting sprays, gels, and clear products. |
Citations:
- Cosmetic Ingredient Review. (2021). Amended safety assessment of benzophenones as used in cosmetics (final report). https://www.cir-safety.org/sites/default/files/benzop032021FAR.pdf
- What it shows: Reported use concentrations.
- U.S. Food and Drug Administration. OTC Monograph M020 — Sunscreen drug products for over-the-counter human use (deemed final order), including sulisobenzone up to 10%. https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse09242021.pdf
- What it shows: Sunscreen rules.
- 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.
- Cosmetic Ingredient Review. (2021). Amended safety assessment of benzophenones as used in cosmetics (final report). https://www.cir-safety.org/sites/default/files/benzop032021FAR.pdf
7. Pros
Claim: A water-soluble, stable UV absorber with a CIR safety conclusion. |
Verification: Supported. Well established for protecting products and hair color.
Citations:
- Cosmetic Ingredient Review. (2021). Amended safety assessment of benzophenones as used in cosmetics (final report). https://www.cir-safety.org/sites/default/files/benzop032021FAR.pdf
- What it shows: Safety conclusion.
- Cosmetic Ingredient Review. (2021). Amended safety assessment of benzophenones as used in cosmetics (final report). https://www.cir-safety.org/sites/default/files/benzop032021FAR.pdf
8. Cons
Claim: Benzophenone-4 can cause allergy, belongs to a scrutinized ingredient family, and cannot support sun-protection claims at stabilizer levels. |
Verification: Supported. We list these limits so you have the full picture:
- Allergy. Uncommon but documented.
- Family scrutiny. Concerns about oxybenzone affect how the whole family is viewed.
- Not a sunscreen at low levels. No SPF claims without OTC compliance.
- Natural standards. Excluded from most natural certifications.
Citations:
- Warshaw, E. M., et al. (2023). Patch testing with benzophenone-3 and -4: The North American Contact Dermatitis Group experience, 2013–2020. Dermatitis, 34(2), 105–112. https://doi.org/10.1089/derm.2022.29013.ewa
- What it shows: Allergy.
- U.S. Food and Drug Administration. OTC Monograph M020 — Sunscreen drug products for over-the-counter human use (deemed final order), including sulisobenzone up to 10%. https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse09242021.pdf
- What it shows: Sunscreen rules.
- Warshaw, E. M., et al. (2023). Patch testing with benzophenone-3 and -4: The North American Contact Dermatitis Group experience, 2013–2020. Dermatitis, 34(2), 105–112. https://doi.org/10.1089/derm.2022.29013.ewa
9. Safety Notes
Claim: Patch test before use; for external use only. |
Verification: Supported. Follow these precautions:
- Patch test any new product on a small area for 24–48 hours before full use.
- If you are allergic to benzophenones or sunscreen ingredients, avoid this product.
- This product is not a sunscreen. Use a broad-spectrum sunscreen for sun protection.
- Stop use if redness, burning, itching, or rash occurs, and talk to a healthcare provider.
- For external use only. Avoid the eyes.
- If you are pregnant, nursing, have a medical condition, or are buying for a child, ask a healthcare provider before use.
Citations:
- Warshaw, E. M., et al. (2023). Patch testing with benzophenone-3 and -4: The North American Contact Dermatitis Group experience, 2013–2020. Dermatitis, 34(2), 105–112. https://doi.org/10.1089/derm.2022.29013.ewa
- What it shows: Allergy.
- Warshaw, E. M., et al. (2023). Patch testing with benzophenone-3 and -4: The North American Contact Dermatitis Group experience, 2013–2020. Dermatitis, 34(2), 105–112. https://doi.org/10.1089/derm.2022.29013.ewa
10. Product-line notes
- ORY® Skincare: For external use only. Not for deep or puncture wounds, animal bites, or serious burns.
- ORY® Haircare: Designed for scalp comfort and the look and feel of hair. Not intended to treat dandruff or scalp conditions, or to promote hair growth or prevent hair loss. If you notice sudden shedding or a persistent itchy, flaking scalp, see a dermatologist.
- ORY® Handmade Soap: Handmade soap is naturally alkaline, and each bar may vary slightly in color, scent, and texture. Not intended to treat eczema or any skin condition.
- ORY® Cosmetics: Lip products are not intended to treat or protect chapped or cracked lips. Do not share applicators, and replace any product that changes color, smell, or texture.
11. References
Peer-reviewed research
- Cosmetic Ingredient Review. (2021). Amended safety assessment of benzophenones as used in cosmetics (final report). https://www.cir-safety.org/sites/default/files/benzop032021FAR.pdf
- Elder, R. L. (Ed.). (1983). Final report on the safety assessment of benzophenones-1, -3, -4, -5, -9, and -11. Journal of the American College of Toxicology, 2(5), 35–77. https://doi.org/10.3109/10915818309140714
- Matta, M. K., et al. (2019). Effect of sunscreen application under maximal use conditions on plasma concentration of sunscreen active ingredients: A randomized clinical trial. JAMA, 321(21), 2082–2091. https://doi.org/10.1001/jama.2019.5586
- Warshaw, E. M., et al. (2023). Patch testing with benzophenone-3 and -4: The North American Contact Dermatitis Group experience, 2013–2020. Dermatitis, 34(2), 105–112. https://doi.org/10.1089/derm.2022.29013.ewa
Government and regulatory sources
- U.S. Food and Drug Administration. OTC Monograph M020 — Sunscreen drug products for over-the-counter human use (deemed final order), including sulisobenzone up to 10%. https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse09242021.pdf
- U.S. Food and Drug Administration. (2019, February 26). Sunscreen drug products for over-the-counter human use (proposed rule), 84 FR 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. 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
