PRACTICE POINT

COMMUNIQUE TO CDA MEMBERS

Sunscreens: Benzene Exposure Risk

Released: July 15, 2021 | Reviewed April 2022

A recent independent US investigation of 294 unique batches of sunscreen and after-sun products found detectable levels of benzene, a known carcinogen, in 78 products (27%).  Of these, 32 of the 40 most contaminated products (80%) were sprays with levels of benzene greater than 0.1 ppm.

On May 24, 2021, Valisure, an independent US pharmaceutical product testing company, submitted a Citizen Petition to the US Food and Drug Administration (FDA) requesting the FDA recall 78 sunscreen and after-sun care products that were found to have levels of benzene in concentrations of 0.1 ppm or greater.

The petition stated that 78 of the 294 sunscreen and after-sun batches (27%) tested by Valisure had detectable levels of benzene. Of the 78 identified, 14 had levels of benzene over 2 ppm, 26 had levels between 0.1 ppm and 2.0 ppm, and 38 had levels under 0.1 ppm. Additionally, 32 of the 40 most contaminated products (80%) were sprays.

The authors of the report suggested the presence of benzene was likely due to contamination during the manufacturing process for several reasons:

  • Benzene was not a listed ingredient
  • Levels of benzene varied significantly from batch to batch, even within a single brand; and
  • Degradation of ingredients with similar chemical structures to benzene – avobenzone, oxybenzone, octisalate, octinoxate, homosalate, and octocrylene – did not cause benzene to form.

Resultantly, Valisure has called on the FDA to investigate the manufacturing processes of sunscreen manufacturers, develop guidance documents for the analysis of benzene in sunscreen products, define a reasonable limit of detection, and revise the sunscreen monograph with the issues identified.

Class action lawsuits against several of the named sunscreen brand owners have since been launched.

It is important to note this investigation was only performed in the United States on sunscreens manufactured in the United States. To date, no similar independent investigation has been performed on Canadian sunscreens.

Practice Points:

  • The use of sunscreen products and other sun safety measures should be continued. Benzene was not detected in 73% of the sunscreen products tested (217 batches from 66 brands). Avoiding an effective preventative measure against UV radiation could be more harmful than exposure to trace amounts of benzene.
  • Sunscreens are a very important, effective, and scientifically-based way to prevent the harmful effects of the sun. Wearing of sun-protective clothing, a wide-brimmed hat, sunglasses, and seeking shade between 11 am and 3 pm, especially around midday, are also appropriate and timely sun safe measures that can be taken.
  • Sunscreen formulations such as creams/lotions/gels should be considered until more is known about the disproportionately high number of sunscreen sprays found to contain benzene.
  • It appears this is a problem within the manufacturing process, not with sunscreen products themselves. The investigation has underscored a need for further regulatory review which the CDA will be monitoring closely.
  • Currently there are no benzene concentration limits in sunscreen. Inhalation and ingestion exposure (e.g., vehicle emissions and contaminated drinking water) have been the primary focus of toxicology investigations. There is likely no safe level of benzene and the CDA will be monitoring closely for recommendations.
  • There is no direct data on systemic absorption of benzene from applying sunscreen with this contaminant. There is indirect data demonstrating sunscreen users of any frequency were less likely to have elevated blood concentrations of benzene compared to never users, suggesting that risk of systemic benzene exposure from sunscreen use may be low (Chang MS, Moore KJ, Trepanowski N, Koru-Sengul T, Hartman RI. 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. 2021 Sep 10:S0190-9622(21)02444-0.).
  • Avobenzone, oxybenzone, octisalate, octinoxate, homosalate, and octocrylene were not found to play a role in the formation of benzene. CDA recognized sunscreens with one or more of these active ingredients are still considered safe and effective. CDA recognized sunscreens can be found on the CDA website at https://dermatology.ca/recognized-products/sunscreen/.
  • Product lot numbers for tested sunscreen and after-sun products can be found on the Valisure website at https://www.valisure.com/.

Additional Information About Benzene:

  • Benzene is a clear, colorless, highly flammable and volatile, liquid aromatic hydrocarbon with a gasoline-like odor. Benzene is produced by both natural and man-made processes.
  • Benzene is used mainly as a starting material in manufacturing other chemicals, including detergents, pesticides, plastics and resins, synthetic rubber, aviation fuel, pharmaceuticals, dye, explosives, PCB gasoline, flavours and perfumes, paints and coatings, nylon intermediates, photographic chemicals. Other natural sources include gas emissions from volcanoes and forest fires. Other than being present in ambient and indoor air, a major additional source of being exposed to benzene is traveling in motor vehicles.
  • Benzene is a known human carcinogen and is linked to an increased risk of developing lymphatic and hematopoietic cancers, acute myelogenous leukemia, as well as chronic lymphocytic leukemia. Benzene association with disorders affecting the lymphohaemopoietic system are mostly linked to long term inhalation exposure.
  • Long-term (a year or more) exposure to benzene causes neurological symptoms and affects the bone marrow causing aplastic anemia, granulocytopenia, lymphocytopenia, and/or thrombocytopenia. Exposure can include inhalation, skin absorption, ingestion, and skin and/or eye contact. Repeated skin contact can cause redness, blistering, and dry, scaly dermatitis.
  • Most of the exposure resulting in bone marrow depression were noted in workers exposure to long term inhalation of benzene concentrations approximately above 40 ppm. In workers exposed to levels up to 1 ppm, no differences were found. Therefore, the WHO Task Group drew the conclusion that bone marrow depression is not expected to occur for exposure levels of 1 ppm or less for about 10 years. The exposure levels found to be carcinogenic are difficult to ascertain due to cohort studies showing inconsistent results.
  • Resources:

Valisure Findings on Sunscreens Manufactured in the United States

For complete data, see https://www.valisure.com/wp-content/uploads/Valisure-Citizen-Petition-on-Benzene-in-Sunscreen-and-After-sun-Care-Products-v9.7.pdf.

Table 2: Benzene detected in concentrations at 2 ppm or higher (14 products)

Brand NameTypeDescriptionUPCLotExp.Benzene Avg ppm
NeutrogenaSprayUltra Sheer Weightless Sunscreen Spray, SPF 100+08680010041604820E042022-016.26
6.77*
NeutrogenaSprayUltra Sheer Weightless Sunscreen Spray, SPF 7008680010040907020E012023-025.96
NeutrogenaSprayUltra Sheer Weightless Sunscreen Spray, SPF 7008680010040906920E012023-025.76
Sun BumGelCool Down Gel871760002005S0082C—5.33
5.49*
NeutrogenaSprayUltra Sheer Weightless Sunscreen Spray, SPF 7008680010040902320E012022-125.30
NeutrogenaSprayBeach Defense Oil-Free Body Sunscreen Spray – SPF 10008680010144404721E022023-015.20
5.59*
CVS HealthSprayAfter-sun Aloe Vera Soothing Spray0504283908328140449A—4.71
4.55*
NeutrogenaSprayInvisible Daily Defense Body Sunscreen Broad Spectrum SPF 60+08680011154204921E012024-014.65
5.27*
NeutrogenaSprayUltra Sheer Weightless Sunscreen Spray, SPF 100+08680010041603120E022021-124.11
6.00**
NeutrogenaSprayBeach Defense Oil-Free Body Sunscreen Spray – SPF 10008680010144428020E012022-094.01
4.00*
CVS HealthSprayAfter-sun Aloe Vera Soothing Spray0504283908324111849A—3.58
3.93*
NeutrogenaSprayBeach Defense Spray Body Sunscreen SPF 5008680011254925520E012023-083.52
3.71*
NeutrogenaSprayBeach Defense Oil-Free Body Sunscreen Spray – SPF 10008680010144431420E042022-103.08
2.64*
Fruit of the EarthGelAloe Vera Gel0716610012006612940A—2.78
2.94*

*    Results from testing site: Chemical and Biophysical Instrumentation Center, Yale University
**   Results from testing site: Boston Analytical

Table 3: Benzene detected in concentrations between 0.1 ppm to 2 ppm (26 products)

Brand NameTypeDescriptionUPCLotExp.Benzene Avg ppm
NeutrogenaSprayInvisible Daily Defense Body Sunscreen Broad Spectrum SPF 60+08680011154217820E012023-051.99
1.66*
NeutrogenaSprayUltra Sheer Weightless Sunscreen Spray, SPF 100+08680010041606420E052022-021.44
1.06*
Raw ElementsLotionEco Formula Sunscreen Lotion SPF 3085885500200358J192021-071.35
1.31*
CVS HealthSprayAfter-sun Aloe Vera Soothing Spray0504283908321101990A—0.90
1.04*
NeutrogenaSprayUltra Sheer Weightless Sunscreen Spray, SPF 7008680010040926119E012022-080.87
CVS HealthGelAfter-sun Aloe Vera Moisturizing Gel0504283248374500231A—0.81
0.98*
NeutrogenaSprayUltra Sheer Weightless Sunscreen Spray, SPF 100+08680010041608119F362022-020.77
SunBurntGelAdvanced After-Sun Gel32433021006062R202022-120.75
0.87*
NeutrogenaSprayUltra Sheer Weightless Sunscreen Spray, SPF 100+08680010041632619E062021-100.73
GoodsenseLotionSunscreen Lotion SPF 308460360011430706069202022-070.71
NeutrogenaSprayCoolDry Sport Water-Resistant Sunscreen Spray SPF 7008680010037933719E012022-100.66
NeutrogenaSprayUltra Sheer Body Mist Sunscreen Broad Spectrum SPF 30 Spray08680010038628219E022021-090.49
Banana BoatSprayKids Max Protect & Play Sunscreen C-Spray SPF 1000796560508202009103462023-020.41
0.43*
NeutrogenaSprayBeach Defense Oil-Free Body Sunscreen Spray – SPF 10008680010144435219E052021-110.41
NeutrogenaSprayUltra Sheer Weightless Sunscreen Spray, SPF 100+08680010041629519E022021-090.37
0.38*
Banana BoatSprayUltraMist Deep Tanning Dry Oil Continuous Clear Spray SPF 4796560466322009440222023-030.36
Banana BoatSprayKids Max Protect & Play Sunscreen C-Spray SPF 1000796560508202002736342022-120.19
NeutrogenaSprayUltra Sheer Weightless Sunscreen Spray, SPF 7008680010040913019F842022-040.18
NeutrogenaSprayUltra Sheer Body Mist Sunscreen Broad Spectrum SPF 4508680010039315719F832022-050.15
Banana BoatSprayUltra Sport Clear Sunscreen Spray SPF 100796560508062010607922023-030.15
NeutrogenaLotionUltra Sheer Dry-Touch Water Resistant Sunscreen SPF 70868006877020090L00692022-060.13
NeutrogenaSprayCoolDry Sport Water-Resistant Sunscreen Spray SPF 5008680010036215619F252022-050.13
TopCare EverydayLotionUltimate Sheer Sunscreen Lotion SPF 700368004590079533119A2021-110.12
0.16*
EltaMDSprayUV Aero Broad-Spectrum Full-Body Sunscreen Spray, SPF 4539020502587967155I2022-110.11
0.17*
EltaMDSprayUV Aero Broad-Spectrum Full-Body Sunscreen Spray, SPF 4539020502587967155H2022-110.11
Banana BoatSprayKids Max Protect & Play Sunscreen C-Spray SPF 1000796560508202002436352022-120.11

* Results from testing site: Chemical and Biophysical Instrumentation Center, Yale University

Table 4: Benzene detected in concentrations below lower limit of quantification (38 products)

Brand NameTypeDescriptionUPCLotExp.Benzene Avg ppm
Live Better by CVS HealthSprayBody Mineral Spray Sunscreen SPF 500504285389134270950B2022-03< 0.1
CVS HealthLotionUltra Sheer Broad Spectrum Sunscreen Lotion SPF 100 (050428415528)0504286160625881760A2022-06< 0.1
Ethical ZincLotionNatural Clear Zinc Sunscreen SPF 50+9354028000025A07472022-09< 0.1
Banana BoatSprayProtective Dry Oil Clear Sunscreen Spray with Coconut Oil SPF 15796560448362020238262023-06< 0.1
BabyganicsSprayKid’s Sunscreen Continuous Spray – SPF 508132770175543713449A2021-12< 0.1
WalgreensLotionSport Lotion Sunscreen SPF 500490229774642142499A2021-09< 0.1
Banana BoatSprayUltra Defense Ultra Mist Clear Sunscreen Spray SPF 1000796560508131919325902022-06< 0.1
CVS HealthLotionUltra Sheer Lotion Broad Spectrum Sunscreen SPF 450504286200836060370C2022-02< 0.1
Raw ElementsLotionEco Formula Sunscreen Lotion Tin SPF 3085885500206521J192021-07< 0.1
CoppertoneSprayWhipped Sunscreen Lotion Spray SPF 500411000070949J03CS2021-08< 0.1
CVS HealthLotionUltra Sheer Broad Spectrum Sunscreen Lotion SPF 100 (050428415528)0504286160627470720B2022-03< 0.1
CVS HealthLotion70 Beach Guard Sun Sunscreen SPF 700504284025285980339C2022-01< 0.1
Max BlockLotionSunscreen Lotion 4 Fl Oz Broad Spectrum Water Resistant SPF 30639277292865910472022-01< 0.1
WalgreensLotionBroad Spectrum Sport SPF 50 Sunscreen0490229774714440660B2022-03< 0.1
CVS HealthLotionUltra Sheer Broad Spectrum Sunscreen Lotion SPF 100 (050428415528)0504286160621362040A2022-07< 0.1
TopCare EverydayLotionSport Sunscreen Lotion SPF 700368004563030440090A2023-01< 0.1
Max BlockLotionSport Sunscreen Lotion Water Resistance Blue 30 SPF639277292063001892022-03< 0.1
WalgreensLotionSunscreen Sport SPF 500490229774573232629A2021-09< 0.1
Max BlockLotionSunscreen Lotion 4 Fl Oz Broad Spectrum Water Resistant SPF 30639277292865911882021-12< 0.1
Max BlockLotionSunscreen Lotion 4 Fl Oz Broad Spectrum Water Resistant SPF 3063927729286591188B2021-12< 0.1
Banana BoatSprayKids Sport Sunscreen Lotion Spray SPF 500796560205261925465432022-08< 0.1
TopCare EverydayLotionUltimate Sheer Sun Lotion Sunscreen SPF 550368004562429543129A2021-11< 0.1
SolimoLotionSheer Face Sunscreen Lotion SPF 55 (842379152474 UPC Description)84237916743004953762022-07< 0.1
Max BlockLotionSport Sunscreen Lotion Water Resistance Blue 30 SPF639277292063910512022-02< 0.1
WalgreensLotionSunscreen Sport SPF 500490229774573222629B2021-09< 0.1
NeutrogenaLotionSheer Zinc Dry-Touch Face Sunscreen SPF 500868001108112979L12362022-03< 0.1
CVS HealthSpraySport Clear Spray Sunscreen SPF 100+0504286188687062049B2021-07< 0.1
La Roche-PosaySprayAnthelios Sunscreen Lotion Spray SPF 608831405008412014012302022-02< 0.1
Banana BoatSpraySimply Protect Kids Sunscreen Spray SPF 50+0796560245001936399162022-11< 0.1
EquateLotionKids Broad Spectrum Sunscreen Lotion, SPF 506811310024623941300A2023-05< 0.1
CVS HealthSpraySheer Mist Spray Broad Spectrum Uva/Uvb Cont. Spray Sunscreen SPF 700504284492402700189A2022-01< 0.1
Max BlockLotionSport Sunscreen Lotion Water Resistance Blue 30 SPF639277292063911862021-12< 0.1
NeutrogenaSprayUltra Sheer Weightless Sunscreen Spray, SPF 7008680010040932318F632021-10< 0.1
Sun BumLotionOxy Free Zinc Oxide Sunscreen Lotion – SPF 50871760003903S9351AN2021-12< 0.1
AveenoLotionBaby Continuous Protection Sensitive Skin Sunscreen Lotion Broad Spectrum SPF 503813711645092419L10222022-02< 0.1
Sun BumSprayAfter Sun Cool Down Aloe Vera Spray871760003187S1039D—< 0.1
WalgreensGelAfter Sun Gel0490225073260701970A—< 0.1
Up & UpGelClear Aloe Vera Gel3716618261639701930A—< 0.1

Approved and released by the Canadian Dermatology Association 15 July 2021
Reviewed April 2022