Evaluation of a sunscreen for phototoxic and photo-irritant potential via photo patch testing
DOI:
https://doi.org/10.18203/issn.2455-4529.IntJResDermatol20261099Keywords:
Venusia Sun Unseen Sunscreen, Draize scale, Photo-patch test, Phototoxicity, Skin safetyAbstract
Background: Evaluation of the potential of Venusia Sun Unseen Sunscreen to induce phototoxicity (photo irritation) in adult participants, using a photo patch test technique.
Methods: This is a monocentric, non-randomised, single-application study to evaluate the potential of the Venusia sun unseen sunscreen to induce phototoxicity in adult participants, using a photo patch test technique. Two treatment sites were tested on the back of each subject and the grading was done for erythema/dryness/wrinkles (A) and oedema (O) reactions on the Draize scale. At both sites ~0.04 g of the test sunscreen was applied occlusively (T1 and T2) at visit 1. One additional site (C1) in the adjoining skin was exposed to ultraviolet (UV) light for the same period to act as a control (no product was applied on this site) for the UV exposure. At 24 hrs, T1 and C1 were UV-exposed and T1 reapplied; T2 stayed occlusive. All sites were scored at 48 hrs, with recovery confirmed at 1 week.
Results: The study included 26 healthy male and female participants aged 18-65 years. At 48 hrs, mean combined phototoxicity scores (A + O) were low across sites: 0.04 at control (C1), 0.75 at UV-exposed test site (T1), and 0.96 at unexposed test site (T2). No study-related adverse events (AEs) or intolerances were reported.
Conclusions: Venusia sun unseen sunscreen is well tolerated and suitable for long-term daily use, including in individuals with sensitive skin. Regular application helps reduce cumulative UV damage and lowers the risk of skin cancers.
Metrics
References
Kohli M, Srinivas CR, Saraswat A, Ganjoo A, Kathed A, Patel G, et al. Practical Recommendations for Indians on Sunscreen Use-A Modified Delphi Consensus by Indian Sunscreen Forum (PRISM-ISF). J Cosmet Dermatol. 2025;24(9):e70441. DOI: https://doi.org/10.1111/jocd.70441
D’Orazio J, Jarrett S, Amaro-Ortiz A, Scott T. UV Radiation and the Skin. Int J Mol Sci. 2013;14(6):12222-48. DOI: https://doi.org/10.3390/ijms140612222
Yamaguchi Y, Brenner M, Hearing VJ. The regulation of skin pigmentation. J Biol Chem. 2007;282(38):27557-61. DOI: https://doi.org/10.1074/jbc.R700026200
Fisher GJ, Kang S, Varani J, Bata-Csorgo Z, Wan Y, Datta S, et al. Mechanisms of photoaging and chronological skin aging. Arch Dermatol. 2002;138(11):1462-70. DOI: https://doi.org/10.1001/archderm.138.11.1462
Breakell T, Kowalski I, Foerster Y, Kramer R, Erdmann M, Berking C, et al. Ultraviolet Filters: Dissecting Current Facts and Myths. J Clin Med. 2024 19;13(10):2986. DOI: https://doi.org/10.3390/jcm13102986
Europe PMC. Available at: https://europepmc.org/article/med/35533024. Accessed on 12 January 2026.
Farage MA. The Prevalence of Sensitive Skin. Front Med. 2019;6:98. DOI: https://doi.org/10.3389/fmed.2019.00098
Addor FAS, Barcaui CB, Gomes EE, Lupi O, Marçon CR, Miot HA. Sunscreen lotions in the dermatological prescription: review of concepts and controversies. An Bras Dermatol. 2022;97(2):204-22. DOI: https://doi.org/10.1016/j.abd.2021.05.012
Sunscreen FAQs. Available at: https://www.aad.org/media/stats-sunscreen. Accessed on 12 January 2026.
Li H, Colantonio S, Dawson A, Lin X, Beecker J. Sunscreen Application, Safety, and Sun Protection: The Evidence. J Cutan Med Surg. 2019;23(4):357-69. DOI: https://doi.org/10.1177/1203475419856611
Pai SB, Anchan VN. Phototoxicity and photoallergy-A brief review on pathogenesis, recent advances, and approach to a patient with photosensitivity. Indian J Skin Allergy. 2024;3(1):28-35. DOI: https://doi.org/10.25259/IJSA_9_2024
Phototoxicity-an overview. ScienceDirect Topics. 2025. Available at: https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/phototoxicity. Accessed on 12 January 2026.
Rai R, Thomas M. Photopatch and UV-irradiated patch testing in photosensitive dermatitis. Indian Dermatol Online J. 2016;7(1):12-6. DOI: https://doi.org/10.4103/2229-5178.174319
Randhawa M, Wang S, Leyden JJ, Cula GO, Pagnoni A, Southall MD. Daily Use of a Facial Broad Spectrum Sunscreen Over One-Year Significantly Improves Clinical Evaluation of Photoaging. Dermatol Surg. 2016;42(12):1354-61.
Jansen R, Wang SQ, Burnett M, Osterwalder U, Lim HW. Photoprotection: part I. Photoprotection by naturally occurring, physical, and systemic agents. J Am Acad Dermatol. 2013;69(6):853.e1-12. DOI: https://doi.org/10.1016/j.jaad.2013.08.021
Young AR, Narbutt J, Harrison GI, Lawrence KP, Bell M, O’Connor C, et al. Optimal sunscreen use, during a sun holiday with a very high ultraviolet index, allows vitamin D synthesis without sunburn. Br J Dermatol. 2019;181(5):1052-62. DOI: https://doi.org/10.1111/bjd.17888
How to apply sunscreen. Available at: https://www.aad.org/public/everyday-care/sun-protection/shade-clothing-sunscreen/how-to-apply-sunscreen. Accessed on 12 January 2026.
Sunscreens: An Update. ResearchGate. 2025; Available at: https://www.researchgate.net/ publication/316992665_Sunscreens_An_Update. Accessed on 12 January 2026.
Gianeti MD, Maia Campos PMBG. Efficacy Evaluation of a Multifunctional Cosmetic Formulation: The Benefits of a Combination of Active Antioxidant Substances. Molecules. 2014;19(11):18268-82. DOI: https://doi.org/10.3390/molecules191118268
Damiani E, Rosati L, Castagna R, Carloni P, Greci L. Changes in ultraviolet absorbance and hence in protective efficacy against lipid peroxidation of organic sunscreens after UVA irradiation. J Photochem Photobiol B. 2006;82(3):204-13. DOI: https://doi.org/10.1016/j.jphotobiol.2005.03.011
Gaspar LR, Maia Campos PMBG. Rheological behavior and the SPF of sunscreens. Int J Pharm. 2003;250(1):35-44. DOI: https://doi.org/10.1016/S0378-5173(02)00462-3
Fidanzi C, Iannone M, Tonini G, Romanelli M, Dini V, Janowska A. An adult with allergic contact dermatitis from octocrylene in a sunscreen. Photodermatol Photoimmunol Photomed. 2023;39(4):397-9. DOI: https://doi.org/10.1111/phpp.12842
Berkey C, Oguchi N, Miyazawa K, Dauskardt R. Role of sunscreen formulation and photostability to protect the biomechanical barrier function of skin. Biochem Biophys Rep. 2019;19:100657. DOI: https://doi.org/10.1016/j.bbrep.2019.100657
Ka Y, Lee I, Ji K. Thyroid and growth hormone endocrine disruption and mechanisms of homosalate and octisalate using wild-type, thrαa-/-, and dre-miR-499-/- zebrafish embryo/larvae. Ecotoxicol Environ Saf. 2024;286:117170. DOI: https://doi.org/10.1016/j.ecoenv.2024.117170
Stoeckelhuber M, Scherer M, Peschel O, Leibold E, Bracher F, Scherer G, et al. Human metabolism and urinary excretion kinetics of the UV filter Uvinul A plus® after a single oral or dermal dosage. Int J Hyg Environ Health. 2020;227:113509. DOI: https://doi.org/10.1016/j.ijheh.2020.113509
Pniewska A, Kalinowska-Lis U. A Survey of UV Filters Used in Sunscreen Cosmetics. Appl Sci. 2024;14(8):3302. DOI: https://doi.org/10.3390/app14083302
Chatelain E, Gabard B. Photostabilization of butyl methoxydibenzoylmethane (Avobenzone) and ethylhexyl methoxycinnamate by bis-ethylhexyloxyphenol methoxyphenyl triazine (Tinosorb S), a new UV broadband filter. Photochem Photobiol. 2001;74(3):401-6. DOI: https://doi.org/10.1562/0031-8655(2001)074<0401:POBMAA>2.0.CO;2
How to Use Sunscreen. Sun Safety. Available at: https://www.cancer.org/cancer/risk-prevention/sun-and-uv/how-to-use-sunscreen.html. Accessed on 12 January 2026.
Phillips TJ, Bhawan J, Yaar M, Bello Y, Lopiccolo D, Nash JF. Effect of daily versus intermittent sunscreen application on solar simulated UV radiation-induced skin response in humans. J Am Acad Dermatol. 2000;43(4):610-8. DOI: https://doi.org/10.1067/mjd.2000.107244
Randhawa M, Wang S, Leyden JJ, Cula GO, Pagnoni A, Southall MD. Daily Use of a Facial Broad Spectrum Sunscreen Over One-Year Significantly Improves Clinical Evaluation of Photoaging. Dermatol Surg Off Publ Am Soc Dermatol Surg Al. 2016;42(12):1354-61. DOI: https://doi.org/10.1097/DSS.0000000000000879
Agarwal SB, Godse K, Patil S, Nadkarni N. Knowledge and Attitude of General Population toward Effects of Sun Exposure and Use of Sunscreens. Indian J Dermatol. 2018;63(4):285-91. DOI: https://doi.org/10.4103/ijd.IJD_609_17
Diffey BL. When should sunscreen be reapplied? J Am Acad Dermatol. 2001;45(6):882-5. DOI: https://doi.org/10.1067/mjd.2001.117385