Melatonin

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 melatonin. 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 about hair studies: Some studies on this page tested melatonin in people with hair loss (such as androgenetic alopecia), which is a medical condition, or in cell cultures or animals. Under FDA rules (21 CFR 310.527), a product that claims to grow hair or prevent hair loss is a drug. ORY^® products that contain melatonin are cosmetics that help hair look fuller and thicker and help the scalp feel refreshed; they are not intended to grow hair or treat hair loss.

Not a sleep product: Topical ORY^® products with melatonin are cosmetics. They are not intended to help you sleep, and melatonin does not replace sunscreen.

1. General Description and Role

Verification: Supported, with caveats. We did not find a Cosmetic Ingredient Review (CIR) conclusion for melatonin. The European Scientific Committee on Consumer Safety (SCCS) found melatonin in hair products at 0.0033% does not pose a risk to consumers. Rules differ by country, so ORY^® confirms its status in each market.

Citations:

• • European Commission, Scientific Committee on Consumer Safety. (2010). Opinion on melatonin, SCCS/1315/10 (use in hair products at 0.0033% does not pose a risk to consumer health). https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_024.pdf
    • What it shows: SCCS opinion on melatonin.
  • Fischer, T. W., Slominski, A., Zmijewski, M. A., Reiter, R. J., & Paus, R. (2008). Melatonin as a major skin protectant: From free radical scavenging to DNA damage repair. Experimental Dermatology, 17(9), 713–730. https://doi.org/10.1111/j.1600-0625.2008.00767.x
    • What it shows: Review of melatonin in skin.

2. Composition and Production

Verification: Supported. Its chemistry and antioxidant roles are described in reviews.

Citations:

• • Fischer, T. W., Slominski, A., Zmijewski, M. A., Reiter, R. J., & Paus, R. (2008). Melatonin as a major skin protectant: From free radical scavenging to DNA damage repair. Experimental Dermatology, 17(9), 713–730. https://doi.org/10.1111/j.1600-0625.2008.00767.x
    • What it shows: Review.

3. Skin Type Suitability

Verification: Supported, with caveats. Reviews describe melatonin as an antioxidant in skin; a thesis summary reported less UV redness when melatonin was applied before UV exposure. Melatonin is not a sunscreen, and ORY^® makes no sun-protection claims.

Citations:

• • Fischer, T. W., Slominski, A., Zmijewski, M. A., Reiter, R. J., & Paus, R. (2008). Melatonin as a major skin protectant: From free radical scavenging to DNA damage repair. Experimental Dermatology, 17(9), 713–730. https://doi.org/10.1111/j.1600-0625.2008.00767.x
    • What it shows: Review.
  • Scheuer, C. (2017). Melatonin for prevention of erythema and oxidative stress in response to ultraviolet radiation (doctoral thesis summary). Danish Medical Journal, 64(6), B5358. https://pubmed.ncbi.nlm.nih.gov/?term=Scheuer%20melatonin%20erythema%20oxidative%20stress%20ultraviolet%20Danish%20Medical%20Journal
    • What it shows: Thesis summary of UV studies.
  • 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 sunscreen rules.

4. Hair and Scalp Suitability

Verification: Supported, with caveats. A small randomized pilot trial in women with hair loss and a larger observational series used a 0.1% topical melatonin solution. These studied medical conditions; ORY^® does not claim melatonin grows hair.

Citations:

• • Fischer, T. W., Burmeister, G., Schmidt, H. W., & Elsner, P. (2004). Melatonin increases anagen hair rate in women with androgenetic alopecia or diffuse alopecia: Results of a pilot randomized controlled trial. British Journal of Dermatology, 150(2), 341–345. https://doi.org/10.1111/j.1365-2133.2004.05685.x
    • What it shows: Pilot randomized trial in hair loss.
  • Fischer, T. W., Trüeb, R. M., Hänggi, G., Innocenti, M., & Elsner, P. (2012). Topical melatonin for treatment of androgenetic alopecia. International Journal of Trichology, 4(4), 236–245. https://pubmed.ncbi.nlm.nih.gov/23766606/
    • What it shows: Observational series in hair loss.
  • U.S. Food and Drug Administration. 21 CFR 310.527 — Drug products offered over-the-counter for external use as hair growers or for hair loss prevention. https://www.law.cornell.edu/cfr/text/21/310.527
    • What it shows: FDA hair-growth rule.

5. Benefits

Verification: Supported, with caveats. Evidence comes from reviews, UV studies, and hair-loss studies.

Citations:

• • Fischer, T. W., Slominski, A., Zmijewski, M. A., Reiter, R. J., & Paus, R. (2008). Melatonin as a major skin protectant: From free radical scavenging to DNA damage repair. Experimental Dermatology, 17(9), 713–730. https://doi.org/10.1111/j.1600-0625.2008.00767.x
    • What it shows: Review.

6. Use Across ORY^® Product Lines

Verification: Supported. It is not used in soap.

Citations:

• • European Commission, Scientific Committee on Consumer Safety. (2010). Opinion on melatonin, SCCS/1315/10 (use in hair products at 0.0033% does not pose a risk to consumer health). https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_024.pdf
    • What it shows: Hair-product use level.
  • U.S. Food and Drug Administration. 21 CFR 701.20 — Definition of “soap” (only true soap, made mainly of alkali salts of fatty acids and sold only as soap, is exempt from cosmetic rules). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-G/part-701/subpart-B/section-701.20
    • What it shows: FDA definition of soap; other bars are cosmetics.

7. Pros

Verification: Supported, with caveats. Evidence is from small human studies and reviews.

Citations:

• • Fischer, T. W., Burmeister, G., Schmidt, H. W., & Elsner, P. (2004). Melatonin increases anagen hair rate in women with androgenetic alopecia or diffuse alopecia: Results of a pilot randomized controlled trial. British Journal of Dermatology, 150(2), 341–345. https://doi.org/10.1111/j.1365-2133.2004.05685.x
    • What it shows: Trial.

8. Cons

Verification: Supported. We list these limits so you have the full picture:

• • Regulatory variation. Confirm status per market.
  • No CIR review.
  • Light-sensitive. Opaque packaging.
  • Hormone perception. Explain cosmetic use.

Citations:

• • European Commission, Scientific Committee on Consumer Safety. (2010). Opinion on melatonin, SCCS/1315/10 (use in hair products at 0.0033% does not pose a risk to consumer health). https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_024.pdf
    • What it shows: EU opinion.

9. Safety Notes

Verification: Supported. Follow these precautions:

• • Patch test any new product on a small area for 24–48 hours before full use.
  • If you are pregnant, breastfeeding, or buying for a child, ask a healthcare provider before use.
  • Stop use if redness, burning, itching, or rash occurs, and talk to a healthcare provider.
  • For external use only. Avoid the eyes unless the product is made for the eye area.
  • If you are pregnant, nursing, have a medical condition, or are buying for a child, ask a healthcare provider before use.

Citations:

• • European Commission, Scientific Committee on Consumer Safety. (2010). Opinion on melatonin, SCCS/1315/10 (use in hair products at 0.0033% does not pose a risk to consumer health). https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_024.pdf
    • What it shows: Safety opinion.

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 the look and feel of hair and scalp comfort. Not intended to treat dandruff or scalp conditions, or to promote hair growth or prevent hair loss. If you notice sudden or patchy hair loss, see a dermatologist.
  • ORY^® Handmade Soap: Melatonin is not used in ORY^® soap because it would rinse away or break down.
  • ORY^® Cosmetics: Do not share applicators, and replace any product that changes color, smell, or texture.

11. References

Peer-reviewed research

• • Fischer, T. W., Burmeister, G., Schmidt, H. W., & Elsner, P. (2004). Melatonin increases anagen hair rate in women with androgenetic alopecia or diffuse alopecia: Results of a pilot randomized controlled trial. British Journal of Dermatology, 150(2), 341–345. https://doi.org/10.1111/j.1365-2133.2004.05685.x
  • Fischer, T. W., Slominski, A., Zmijewski, M. A., Reiter, R. J., & Paus, R. (2008). Melatonin as a major skin protectant: From free radical scavenging to DNA damage repair. Experimental Dermatology, 17(9), 713–730. https://doi.org/10.1111/j.1600-0625.2008.00767.x
  • Fischer, T. W., Trüeb, R. M., Hänggi, G., Innocenti, M., & Elsner, P. (2012). Topical melatonin for treatment of androgenetic alopecia. International Journal of Trichology, 4(4), 236–245. https://pubmed.ncbi.nlm.nih.gov/23766606/
  • Scheuer, C. (2017). Melatonin for prevention of erythema and oxidative stress in response to ultraviolet radiation (doctoral thesis summary). Danish Medical Journal, 64(6), B5358. https://pubmed.ncbi.nlm.nih.gov/?term=Scheuer%20melatonin%20erythema%20oxidative%20stress%20ultraviolet%20Danish%20Medical%20Journal

Government and regulatory sources

• • European Commission, Scientific Committee on Consumer Safety. (2010). Opinion on melatonin, SCCS/1315/10 (use in hair products at 0.0033% does not pose a risk to consumer health). https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_024.pdf
  • U.S. Food and Drug Administration. 21 CFR 310.527 — Drug products offered over-the-counter for external use as hair growers or for hair loss prevention. https://www.law.cornell.edu/cfr/text/21/310.527
  • 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. 21 CFR 701.20 — Definition of “soap” (only true soap, made mainly of alkali salts of fatty acids and sold only as soap, is exempt from cosmetic rules). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-G/part-701/subpart-B/section-701.20