ISSUE1731



- Mark Abramowicz, M.D., President has disclosed no relevant financial relationships.
- Jean-Marie Pflomm, Pharm.D., Editor in Chief has disclosed no relevant financial relationships.
- Amy Faucard, MLS, Associate Editor has disclosed no relevant financial relationships.
- Review the efficacy and safety of sunscreen ingredients available in the US.
- Discuss the appropriate use of sunscreens to maximize safety and efficacy.
- Sunscreens that protect against UV radiation reduce the risk of sunburn and photoaging, and regular use has been associated with a reduced risk of some skin cancers.
- Tinted sunscreens add protection against visible light, which can cause hyperpigmentation.
- Use of a broad-spectrum sunscreen with an SPF ≥30 is recommended by the American Academy of Dermatology.
- Sunscreen should be applied 15 minutes before sun exposure and reapplied at least every 2 hours and after swimming or sweating. Most adults require about 1-2 ounces to fully cover all sun-exposed areas.
- Organic sunscreens are absorbed systemically; whether long-term use could result in adverse health effects is unclear.
- Use of the inorganic sunscreens zinc oxide and titanium dioxide is unlikely to result in systemic absorption or toxicity.
- The organic sunscreens oxybenzone and octinoxate have been removed from many sunscreen products because they may be harmful to the environment.
Excessive exposure to ultraviolet (UV) radiation can cause erythema, photoaging, and skin cancer.1,2 Sunscreens are widely used to reduce these risks, but questions remain about their effectiveness and safety. In 2021, the FDA proposed a rule that would require additional safety studies for some sunscreen active ingredients and mandate better UVA protection in sunscreen products.3
UVA and UVB — UV radiation is classified based on wavelength as UVB (290-320 nm), UVA2 (320-340 nm), and UVA1 (340-400 nm). UVA, which makes up 95% of terrestrial UV radiation, penetrates the dermis and causes long-term damage. UVB, which is mostly absorbed in the epidermis, is largely responsible for the erythema of sunburn. Both UVA and UVB radiation can cause photoaging, hyperpigmentation, and skin cancer.4 UVB is strongest at midday; in temperate climates, it is present primarily in late spring, summer, and early autumn. UVA is relatively constant in sunlight throughout the year and, unlike UVB, is not filtered by clear glass.5
SPF/BROAD SPECTRUM RATINGS — The sun protection factor (SPF) is the ratio of the amount of UV radiation required to produce a minimally detectable sunburn on sunscreen-protected skin to the amount required on unprotected skin. The amount of erythema-producing UV radiation (primarily UVB) that penetrates through a sunscreen product to reach the skin is affected by factors such as exposure time, intensity of solar energy, and the amount applied. When properly applied, a sunscreen product with an SPF of 15, 30, or 50 allows 1/15, 1/30, or 1/50, respectively, of erythemogenic UV photons to reach the skin.
There is no specific rating system in the US for how much UVA protection is provided by sunscreens. The FDA has allowed sunscreens to be labeled "broad spectrum" if they protect against UVA and UVB and the UVA protection is proportional to the UVB protection; it has now proposed requiring that sunscreen products with an SPF ≥15 offer greater UVA protection (UVA1/UV ratio ≥0.7) in order to be labeled broad spectrum.3
Manufacturers of broad-spectrum sunscreens with an SPF ≥15 can claim that their products reduce the risk of skin cancer and photoaging if used as directed with other sun protection measures. The FDA and the US Preventive Services Task Force (USPSTF) both recommend use of a broad-spectrum sunscreen with an SPF ≥15.6 The American Academy of Dermatology recommends use of a broad-spectrum, water-resistant sunscreen with an SPF ≥30.7 The FDA has proposed a maximum labeled SPF value of 60+ because data showing that sunscreen products with SPF values >60 provide additional clinical benefits are lacking.3
Concerns have been raised that the current rating system for commercial sunscreens is misleading with regard to the actual protection provided against the adverse effects of sun exposure. In addition, some inorganic sunscreen products include non-FDA-approved organic filters (e.g., butyloctyl salicylate), listed as inactive ingredients, to boost the SPF.8
In the amounts customarily applied to skin, no sunscreen product provides the labeled degree of protection. The FDA requires that SPF values be determined after applying 2 mg/cm2 of the product. At 2 mg/cm2, a 4-ounce container provides 2-4 whole body applications for an adult. Studies have shown that consumers usually apply 0.5-1.0 mg/cm2 or less. Applying 0.5-mg/cm2 doses of sunscreens labeled SPF 30-100 has been shown to provide an actual SPF that is about 25% of the labeled SPF.9
ACTIVE INGREDIENTS — Organic – Several organic sunscreens that absorb different wavelengths of UV radiation are approved by the FDA (see Table 1). Avobenzone is an effective UVA1 absorber, and it also absorbs some UVA2, but it is photolabile; its efficacy decreases by about 60% after 60 minutes of exposure to sunlight. Oxybenzone absorbs both UVB and UVA2. Octinoxate is a potent UVB absorber, but it is photolabile. Octisalate and homosalate are weak UVB absorbers; they are generally used with other agents as photostabilizers. Octocrylene absorbs UVB and UVA2 and is photostable; when combined with other sunscreens, it can improve the photostability of the entire product. Ecamsule is photostable and absorbs both UVA2 and UVA1.10,11
PABA (para-aminobenzoic acid) and trolamine salicylate are not considered GRASE (generally recognized as safe and effective) by the FDA and are no longer available in sunscreen products sold in the US.3
Bemotrizinol (PARSOL Shield; also sold as Tinosorb S, Escalol S), a photostable UVA and UVB filter that has been available in Europe and Australia for many years, is under review by the FDA and may be available in 2026. In a preliminary trial in healthy adults, maximal application of a sunscreen formulation containing 6% bemotrizinol did not result in meaningful systemic exposure (only 13 of 299 plasma samples showed quantifiable bemotrizinol).12
Inorganic – The two FDA-approved inorganic sunscreens, zinc oxide and titanium dioxide, block UVB, UVA2, and UVA1 penetration, and they are photostable. Zinc oxide offers better UVA protection than titanium dioxide. Used together, they provide broad UV protection.13 Nanoparticle formulations are now widely used because they are less visible on the skin, but they may also be less effective.14
OTHER INGREDIENTS — In addition to UV filters, tinted sunscreens, which are often available in a variety of shades to match different skin colors, contain iron oxide pigments (and less commonly non-nanosized pigmentary titanium dioxide) that physically block visible light (400-700 nm). Visible light can induce erythema in light-skinned people and pigmentary changes in dark-skinned people and may play a role in photoaging and some photodermatoses.10,15
Antioxidants such as vitamins E and C and niacinamide are added to sunscreen products to reduce oxidative stress caused by UV radiation and increase photoprotective effects,16,17 but they are not very stable and it is unclear whether they retain their activity when they penetrate the skin. Some plant-derived extracts with antioxidant effects have also demonstrated photoprotective activity in vitro and in animals. Green tea extract, carotenoids such as beta-carotene, lycopene and lutein, and Polypodium leucotomos extract (PLE; derived from a South American species of fern) have been shown to reduce sunburn intensity and improve signs of photodamage in humans, but data are limited.18
FORMULATIONS — Sunscreen dosage forms that the FDA has proposed to classify as GRASE include oils, lotions, creams, gels, butters, pastes, ointments, and sticks. Wipes, towelettes, body washes, and shampoos are excluded for lack of data. Sprays and powders require additional testing. Sunscreen sprays are flammable, and burns requiring hospitalization have been reported. Based on animal models, the small particles in sprays and powders could pose inhalation risks.
PREVENTION OF SKIN CANCER — Long-term daily sunscreen use (combined with other sun-protective measures) has been shown to reduce the risk of some nonmelanoma skin cancers.19 Using a sunscreen with a high SPF may prevent DNA damage to the skin even when the amount applied is less than optimal.20
Melanoma – Fair skin, use of tanning beds, and a history of sunburn are associated with increased melanoma risk.6 In an Australian population-based, case-control study that included 603 adults 18-39 years old with a first primary cutaneous melanoma diagnosis and 1088 controls 18-44 years old, regular sunscreen use in childhood and early adulthood was associated with a reduced risk of cutaneous melanoma.21 In a prospective trial, 1621 Australians 25-75 years old were randomized to use an SPF 16 sunscreen either daily or in a discretionary manner (generally 0-2 times weekly) for 4 years. Daily sunscreen users had 50% fewer new primary melanomas (11 vs 22) and 73% fewer invasive melanomas (3 vs 11) than discretionary users 14 years after randomization.22 In a US casecontrol study, high cumulative lifetime sun exposure was associated with an increased risk of cutaneous melanoma in subjects with medium or dark skin, but not in those with fair skin.23
SAFETY — Organic – All organic sunscreens, especially oxybenzone, can cause contact allergic and photoallergic reactions, but severe reactions are uncommon.24 Estrogenic and anti-androgenic activity and neurotoxicity have been reported in vitro and in some animal studies.25 These agents penetrate the epidermis and are absorbed systemically; detectable levels have been reported in human plasma, urine, breast milk, amniotic fluid, and fetal and cord blood.26
Two randomized, open-label trials were conducted by the FDA to determine whether the active ingredients in some commercially available sunscreen products are absorbed systemically.27,28 In the first trial, a sunscreen product was applied under maximal use conditions (2 mg/cm2 every 2 hours [4 times per day] to 75% of body surface area) for 4 days; the 4 active ingredients studied (3% avobenzone, 4-6% oxybenzone, 2.35-10% octocrylene, 2% ecamsule) reached mean maximum plasma concentrations that exceeded the FDA threshold for safety testing (>0.5 ng/mL) and they remained in plasma for at least 3 days after the last application.
In the second trial, the sunscreen product was applied once on day 1, followed by maximal application on days 2-4. Mean maximum plasma concentrations after a single application were >0.5 ng/mL with all 6 of the active ingredients studied (3% avobenzone, 4-6% oxybenzone, 6-10% octocrylene, 10-15% homosalate, 5% octisalate, 7.5% octinoxate); the highest levels occurred with oxybenzone (85-94 ng/mL). All of the active ingredients had long terminal half-lives (mean range 27.3-157.4 hours); concentrations of homosalate and oxybenzone were >0.5 ng/mL in >50% of participants at 21 days.
Whether such exposure could affect hormone levels or result in other adverse effects in humans is unclear.26,29 The FDA has stated that additional studies are needed to determine the clinical significance of these findings. A study in 441 healthy women found an association between oxybenzone exposure and urinary markers of kidney dysfunction.30
Inorganic – Studies have found that titanium dioxide and zinc oxide nanoparticles either do not penetrate or minimally penetrate the stratum corneum and underlying layers of skin, suggesting that systemic absorption and toxicity are unlikely.31,32 The FDA has stated that available evidence supports a GRASE classification for zinc oxide and titanium dioxide.3
Benzene – In 2021, an independent laboratory (Valisure) tested 293 samples of commercially available sunscreens and after-sun products and found that 14 (4.8%), mainly sprays, contained benzene, a known carcinogen, at concentrations above 2 parts per million (the maximum allowed by the FDA).33 According to the FDA, the contamination may be related to inactive ingredients such as isobutane (a spray propellant); some aerosol sunscreen products with high benzene concentrations have been recalled, and certain manufacturers are now required to test their products for benzene contamination.34 A retrospective analysis of data from the National Health and Nutrition Examination Survey suggested that the risk of systemic benzene exposure from sunscreen use may be low in US adults.35
Environmental Safety – Hawaii, Key West (Florida), the US Virgin Islands, and some other tourist destinations (e.g., Aruba, Palau, Bonaire) have passed ordinances and/or legislation banning the sale of sunscreens that contain oxybenzone and/or octinoxate because they can cause coral reef bleaching.36 The US Virgin Islands has also banned octocrylene. The FDA intends to evaluate the potential environmental effects associated with use of oxybenzone and octinoxate in sunscreen products.37 Detectable concentrations of sunscreen active ingredients have been observed in some fish species and adverse reproductive effects have been reported.38 Nanoparticles of zinc oxide and titanium dioxide may also have detrimental effects on the environment, including coral bleaching.39
INFANTS AND CHILDREN — Sunscreen use should generally be avoided in infants <6 months old. A broad-spectrum sunscreen with an SPF ≥30 is recommended for children >6 months old during any sun exposure that might burn unprotected skin. Inorganic sunscreens are less likely than organic sunscreens to cause irritation and sensitization.7,40
PREGNANCY — Data on sunscreen use in pregnancy are limited. The results of human and animal studies suggest that the endocrine-disrupting effects of oxybenzone may result in reproductive toxicity, including adverse effects on fetal growth41,42; an association between maternal oxybenzone exposure and Hirschsprung's disease in their offspring has been observed.43 Inorganic sunscreens are generally preferred for pregnant women.
VITAMIN D AND SUNSCREENS — The UVB dose is the most important factor in vitamin D synthesis. The amount of UVB required for production of vitamin D is very small and is much lower than the amount that produces sunburn.25 Most people require only 2-8 minutes of unprotected exposure to summer sun to maximize synthesis of vitamin D3.
Whether sunscreen use could lead to vitamin D3 deficiency is unclear. Two reviews have evaluated the association between sunscreen use and vitamin D3 levels. Although sunscreen use decreased vitamin D3 production in some experimental studies, most randomized, controlled field trials found no change in vitamin D3 levels with daily application of a sunscreen with an SPF of ~16.44,45 A controlled study in subjects on a 1-week sun holiday found that optimal SPF 15 sunscreen use prevented erythema and increased vitamin D production; synthesis of vitamin D was greater with use of a sunscreen product with a high UVA protection factor compared to one with a low UVA protection factor because it allowed more UVB transmission.46 No trials have evaluated the effects of high-SPF sunscreens (SPF ≥50) on vitamin D3 synthesis.
APPLICATION — For maximum efficacy, sunscreen should be applied 15 minutes before sun exposure and reapplied at least every 2 hours and after swimming or sweating. Water-resistant sunscreens remain effective for 40 or 80 minutes while swimming or sweating; no sunscreens are waterproof. Sunscreen should be applied to all sun-exposed areas, using 2 to 3 tablespoons of sunscreen for the entire body and 1 to 2 teaspoons for the face and neck.16 An appropriate dose of spray sunscreen can be difficult to determine; spraying the sunscreen until the skin glistens and then rubbing it in has been recommended.7
With Insect Repellent – When using both a sunscreen and an insect repellent, the sunscreen should be applied first. Applying the insect repellent N,N-diethyl-m-tolumide (DEET) after sunscreen has been shown to reduce the SPF of the sunscreen, but applying DEET before sunscreen may increase absorption of DEET. Use of products containing both a sunscreen and an insect repellent is not recommended because the sunscreen may need to be reapplied more often and in greater amounts than the repellent.
OTHER SUN PROTECTION MEASURES — In addition to sunscreen use, The American Academy of Dermatology recommends seeking shade during hours of peak sunlight (10am-2pm) and wearing sun-protective clothing, including long-sleeve shirts, pants, wide-brimmed hats, and sunglasses with UV protection. Factors that affect the level of UV protection from clothing include fabric color, fabric type, and tightness of the weave. The ultraviolet protection factor (UPF) is a measure of how effective a fabric is at blocking UV radiation; UV protection is considered very good with a UPF rating of 30-49 and excellent with a rating of 50+.47 Washing clothes once with RIT Sun Guard, a commercially available laundry product containing a broad-spectrum UV absorber (Tinosorb FD), can confer a UPF of 30 that lasts through 20 additional washings.
- U Panich et al. Ultraviolet radiation-induced skin aging: the role of DNA damage and oxidative stress in epidermal stem cell damage mediated skin aging. Stem Cells Int 2016; 2016:7370642. doi:10.1155/2016/7370642
- M Arnold et al. Global burden of cutaneous melanoma attributable to ultraviolet radiation in 2012. Int J Cancer 2018; 143:1305. doi:10.1002/ijc.31527
- FDA. Proposed Order (OTC000008): Amending over-the-counter (OTC) monograph M020: sunscreen drug products for OTC human use. September 24, 2021. Available at: https://bit.ly/3SVWg3n.gov. Accessed June 2, 2025.
- RE Neale et al. Environmental effects of stratospheric ozone depletion, UV radiation, and interactions with climate change: UNEP Environmental Effects Assessment Panel, update 2020. Photochem Photobiol Sci 2021; 20:1. doi:10.1007/s43630-020-00001-x
- F Wang et al. Dermal damage promoted by repeated low-level UVA-1 exposure despite tanning response in human skin. JAMA Dermatol 2014; 150:401. doi:10.1001/jamadermatol.2013.8417
- US Preventive Services Task Force. Behavioral counseling to prevent skin cancer: US Preventive Services Task Force recommendation statement. JAMA 2018; 319:1134. doi:10.1001/jama.2018.1623
- American Academy of Dermatology. Shade, clothing, and sunscreen. Available at: https://bit.ly/4kqHQ7q. Accessed June 2, 2025.
- S Moradi Tuchayi et al. Sunscreens: misconceptions and misinformation. J Invest Dermatol 2023; 143:1406. doi:10.1016/j.jid.2023.03.1677
- H Ou-Yang et al. High-SPF sunscreens (SPF ≥70) may provide ultraviolet protection above minimal recommended levels by adequately compensating for lower sunscreen user application amounts. J Am Acad Dermatol 2012; 67:1220. doi:10.1016/j.jaad.2012.02.029
- LL Guan et al. Sunscreens and photoaging: a review of current literature. Am J Clin Dermatol 2021; 22:819. doi:10.1007/s40257-021-00632-5
- A new sunscreen agent. Med Lett Drugs Ther 2007; 49:41.
- CD D'Ruiz et al. Preliminary clinical pharmacokinetic evaluation of bemotrizinol – a new sunscreen active ingredient being considered for inclusion under FDA's over-the-counter (OTC) sunscreen monograph. Regul Toxicol Pharmacol 2023; 139:105344. doi:10.1016/j.yrtph.2023.105344
- SL Schneider and HW Lim. A review of inorganic UV filters zinc oxide and titanium dioxide. Photodermatol Photoimmunol Photomed 2019; 35:442. doi:10.1111/phpp.12439
- JB Mancuso et al. Sunscreens: an update. Am J Clin Dermatol 2017; 18:643. doi:10.1007/s40257-017-0290-0
- AB Lyons et al. Photoprotection beyond ultraviolet radiation: a review of tinted sunscreens. J Am Acad Dermatol 2021; 84:1393. doi:10.1016/j.jaad.2020.04.079
- S Abdel Azim et al. Sunscreens part 1: mechanisms and efficacy. J Am Acad Dermatol 2025; 92:677. doi:10.1016/j.jaad.2024.02.065
- A Jesus et al. Antioxidants in sunscreens; which and what for? Antioxidants (Basel) 2023; 12:138. doi:10.3390/antiox12010138
- L Rabinovich and V Kazlouskaya. Herbal sun protection agents: human studies. Clin Dermatol 2018; 36:369. doi:10.1016/j.clindermatol.2018.03.014
- M Sander et al. The efficacy and safety of sunscreen use for the prevention of skin cancer. CMAJ 2020; 192:E1802. doi:10.1503/cmaj.201085
- AR Young et al. Sub-optimal application of a high SPF sunscreen prevents epidermal DNA damage in vivo. Acta Derm Venereol 2018; 98:880. doi:10.2340/00015555-2992
- CG Watts et al. Sunscreen use and melanoma risk among young Australian adults. JAMA Dermatol 2018; 154:1001. doi:10.1001/jamadermatol.2018.1774
- AC Green et al. Reduced melanoma after regular sunscreen use: randomized trial follow-up. J Clin Oncol 2011; 29:257. doi:10.1200/jco.2010.28.7078
- LK Dennis. Cumulative sun exposure and melanoma in a population-based case-control study: does sun sensitivity matter? Cancers (Basel) 2022; 14:1008. doi:10.3390/cancers14041008
- KA McDonald et al. Review on photoprotection: a clinician's guide to the ingredients, characteristics, adverse effects, and disease-specific benefits of chemical and physical sunscreen compounds. Arch Dermatol Res 2023; 315:735. doi:10.1007/s00403-022-02483-4
- T Breakell et al. Ultraviolet filters: dissecting current facts and myths. J Clin Med 2024; 13:2986. doi:10.3390/jcm13102986
- S Suh et al. The banned sunscreen ingredients and their impact on human health: a systematic review. Int J Dermatol 2020; 59:1033. doi:10.1111/ijd.14824
- MK Matta et al. Effect of sunscreen application under maximal use conditions on plasma concentration of sunscreen active ingredients: a randomized clinical trial. JAMA 2019; 321:2082. doi:10.1001/jama.2019.5586
- MK Matta et al. Effect of sunscreen application on plasma concentration of sunscreen active ingredients: a randomized clinical trial. JAMA 2020; 323:256. doi:10.1001/jama.2019.20747
- JA Ruszkiewicz et al. Neurotoxic effect of active ingredients in sunscreen products, a contemporary review. Toxicol Rep 2017; 4:245. doi:10.1016/j.toxrep.2017.05.006
- H Kang et al. Urinary metabolites of dibutyl phthalate and benzophenone-3 are potential chemical risk factors of chronic kidney function markers among healthy women. Environ Int 2019; 124:354. doi:10.1016/j.envint.2019.01.028
- Australian Government Department of Health. Therapeutic Goods Administration. Literature review on the safety of titanium dioxide and zinc oxide nanoparticles in sunscreens. Scientific review report. Version 1.1, August 2016. Available at: https://bit.ly/4dBLx7P. Accessed June 2, 2025.
- YH Mohammed et al. Support for the safe use of zinc oxide nanoparticle sunscreens: lack of skin penetration or cellular toxicity after repeated application in volunteers. J Invest Dermatol 2019; 139:308. doi:10.1016/j.jid.2018.08.024
- A Hudspeth et al. Independent sun care product screening for benzene contamination. Environ Health Perspect 2022; 130:37701. doi:10.1289/ehp10386
- FDA. FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs. February 24, 2025. Available at: https://bit.ly/4jHf55D. Accessed June 2, 2025.
- MS Chang et al. Sunscreen use is not associated with increased blood concentrations of benzene among adults in the United States: data from the National Health and Nutrition Examination Survey 2003-2006 and 2009-2018. J Am Acad Dermatol 2022; 87:440. doi:10.1016/j.jaad.2021.09.003
- CA Downs et al. Toxicopathological effects of the sunscreen UV filter, oxybenzone (benzophenone-3), on coral planulae and cultured primary cells and its environmental contamination in Hawaii and the U.S. Virgin Islands. Arch Environ Contam Toxicol 2016; 70:265. doi:10.1007/s00244-015-0227-7
- FDA. Environmental Impact Statement (EIS) for certain sunscreen drug products. October 13, 2021. Available at: https://bit.ly/3weZrFT. Accessed June 2, 2025.
- SL Schneider and HW Lim. Review of environmental effects of oxybenzone and other sunscreen active ingredients. J Am Acad Dermatol 2019; 80:266. doi:10.1016/j.jaad.2018.06.033
- D Fivenson et al. Sunscreens: UV filters to protect us: part 2-increasing awareness of UV filters and their potential toxicities to us and our environment. Int J Women's Dermatol 2021; 7:45. doi:10.1016/j.ijwd.2020.08.008
- FDA. Sunscreen: how to help protect your skin from the sun. August 16, 2024. Available at: https://bit.ly/4mAxbc1. Accessed June 2, 2025.
- M Ghazipura et al. Exposure to benzophenone-3 and reproductive toxicity: a systematic review of human and animal studies. Reprod Toxicol 2017; 73:175. doi:10.1016/j.reprotox.2017.08.015
- H Teiri et al. The association of prenatal exposure to benzophenones with gestational age and offspring size at birth. Environ Sci Pollut Res Int 2022; 29:24682. doi:10.1007/s11356-021-17634-9
- JC DiNardo and CA Downs. Can oxybenzone cause Hirschsprung's disease? Reprod Toxicol 2019; 86:98. doi:10.1016/j.reprotox. 2019.02.014
- RE Neale et al. The effect of sunscreen on vitamin D: a review. Br J Dermatol 2019; 181:907. doi:10.1111/bjd.17980
- T Passeron et al. Sunscreen photoprotection and vitamin D status. Br J Dermatol 2019; 181:916. doi:10.1111/bjd.17992
- AR Young 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; 181:1052. doi:10.1111/bjd.17888
- Skin Cancer Foundation. Sun-protective clothing. April 2025. Available at: https://bit.ly/43ASyBa. Accessed June 2, 2025.