PRACTICE POINT

COMMUNIQUE TO CDA MEMBERS

Sunscreens: Benzene Exposure Risk

Released: July 15, 2021

 

 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.
  • 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 Name Type Description UPC Lot Exp. Benzene Avg ppm
Neutrogena Spray Ultra Sheer Weightless Sunscreen Spray, SPF 100+ 086800100416 04820E04 2022-01 6.26
6.77*
Neutrogena Spray Ultra Sheer Weightless Sunscreen Spray, SPF 70 086800100409 07020E01 2023-02 5.96
Neutrogena Spray Ultra Sheer Weightless Sunscreen Spray, SPF 70 086800100409 06920E01 2023-02 5.76
Sun Bum Gel Cool Down Gel 871760002005 S0082C 5.33
5.49*
Neutrogena Spray Ultra Sheer Weightless Sunscreen Spray, SPF 70 086800100409 02320E01 2022-12 5.30
Neutrogena Spray Beach Defense Oil-Free Body Sunscreen Spray – SPF 100 086800101444 04721E02 2023-01 5.20
5.59*
CVS Health Spray After-sun Aloe Vera Soothing Spray 050428390832 8140449A 4.71
4.55*
Neutrogena Spray Invisible Daily Defense Body Sunscreen Broad Spectrum SPF 60+ 086800111542 04921E01 2024-01 4.65
5.27*
Neutrogena Spray Ultra Sheer Weightless Sunscreen Spray, SPF 100+ 086800100416 03120E02 2021-12 4.11
6.00**
Neutrogena Spray Beach Defense Oil-Free Body Sunscreen Spray – SPF 100 086800101444 28020E01 2022-09 4.01
4.00*
CVS Health Spray After-sun Aloe Vera Soothing Spray 050428390832 4111849A 3.58
3.93*
Neutrogena Spray Beach Defense Spray Body Sunscreen SPF 50 086800112549 25520E01 2023-08 3.52
3.71*
Neutrogena Spray Beach Defense Oil-Free Body Sunscreen Spray – SPF 100 086800101444 31420E04 2022-10 3.08
2.64*
Fruit of the Earth Gel Aloe Vera Gel 071661001200 6612940A 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 Name Type Description UPC Lot Exp. Benzene Avg ppm
Neutrogena Spray Invisible Daily Defense Body Sunscreen Broad Spectrum SPF 60+ 086800111542 17820E01 2023-05 1.99
1.66*
Neutrogena Spray Ultra Sheer Weightless Sunscreen Spray, SPF 100+ 086800100416 06420E05 2022-02 1.44
1.06*
Raw Elements Lotion Eco Formula Sunscreen Lotion SPF 30 858855002003 58J19 2021-07 1.35
1.31*
CVS Health Spray After-sun Aloe Vera Soothing Spray 050428390832 1101990A 0.90
1.04*
Neutrogena Spray Ultra Sheer Weightless Sunscreen Spray, SPF 70 086800100409 26119E01 2022-08 0.87
CVS Health Gel After-sun Aloe Vera Moisturizing Gel 050428324837 4500231A 0.81
0.98*
Neutrogena Spray Ultra Sheer Weightless Sunscreen Spray, SPF 100+ 086800100416 08119F36 2022-02 0.77
SunBurnt Gel Advanced After-Sun Gel 324330210060 62R20 2022-12 0.75
0.87*
Neutrogena Spray Ultra Sheer Weightless Sunscreen Spray, SPF 100+ 086800100416 32619E06 2021-10 0.73
Goodsense Lotion Sunscreen Lotion SPF 30 846036001143 070606920 2022-07 0.71
Neutrogena Spray CoolDry Sport Water-Resistant Sunscreen Spray SPF 70 086800100379 33719E01 2022-10 0.66
Neutrogena Spray Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 30 Spray 086800100386 28219E02 2021-09 0.49
Banana Boat Spray Kids Max Protect & Play Sunscreen C-Spray SPF 100 079656050820 200910346 2023-02 0.41
0.43*
Neutrogena Spray Beach Defense Oil-Free Body Sunscreen Spray – SPF 100 086800101444 35219E05 2021-11 0.41
Neutrogena Spray Ultra Sheer Weightless Sunscreen Spray, SPF 100+ 086800100416 29519E02 2021-09 0.37
0.38*
Banana Boat Spray UltraMist Deep Tanning Dry Oil Continuous Clear Spray SPF 4 79656046632 200944022 2023-03 0.36
Banana Boat Spray Kids Max Protect & Play Sunscreen C-Spray SPF 100 079656050820 200273634 2022-12 0.19
Neutrogena Spray Ultra Sheer Weightless Sunscreen Spray, SPF 70 086800100409 13019F84 2022-04 0.18
Neutrogena Spray Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45 086800100393 15719F83 2022-05 0.15
Banana Boat Spray Ultra Sport Clear Sunscreen Spray SPF 100 79656050806 201060792 2023-03 0.15
Neutrogena Lotion Ultra Sheer Dry-Touch Water Resistant Sunscreen SPF 70 86800687702 0090L0069 2022-06 0.13
Neutrogena Spray CoolDry Sport Water-Resistant Sunscreen Spray SPF 50 086800100362 15619F25 2022-05 0.13
TopCare Everyday Lotion Ultimate Sheer Sunscreen Lotion SPF 70 036800459007 9533119A 2021-11 0.12
0.16*
EltaMD Spray UV Aero Broad-Spectrum Full-Body Sunscreen Spray, SPF 45 390205025879 67155I 2022-11 0.11
0.17*
EltaMD Spray UV Aero Broad-Spectrum Full-Body Sunscreen Spray, SPF 45 390205025879 67155H 2022-11 0.11
Banana Boat Spray Kids Max Protect & Play Sunscreen C-Spray SPF 100 079656050820 200243635 2022-12 0.11

* 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 Name Type Description UPC Lot Exp. Benzene Avg ppm
Live Better by CVS Health Spray Body Mineral Spray Sunscreen SPF 50 050428538913 4270950B 2022-03 < 0.1
CVS Health Lotion Ultra Sheer Broad Spectrum Sunscreen Lotion SPF 100 (050428415528) 050428616062 5881760A 2022-06 < 0.1
Ethical Zinc Lotion Natural Clear Zinc Sunscreen SPF 50+ 9354028000025 A0747 2022-09 < 0.1
Banana Boat Spray Protective Dry Oil Clear Sunscreen Spray with Coconut Oil SPF 15 79656044836 202023826 2023-06 < 0.1
Babyganics Spray Kid’s Sunscreen Continuous Spray – SPF 50 813277017554 3713449A 2021-12 < 0.1
Walgreens Lotion Sport Lotion Sunscreen SPF 50 049022977464 2142499A 2021-09 < 0.1
Banana Boat Spray Ultra Defense Ultra Mist Clear Sunscreen Spray SPF 100 079656050813 191932590 2022-06 < 0.1
CVS Health Lotion Ultra Sheer Lotion Broad Spectrum Sunscreen SPF 45 050428620083 6060370C 2022-02 < 0.1
Raw Elements Lotion Eco Formula Sunscreen Lotion Tin SPF 30 858855002065 21J19 2021-07 < 0.1
Coppertone Spray Whipped Sunscreen Lotion Spray SPF 50 041100007094 9J03CS 2021-08 < 0.1
CVS Health Lotion Ultra Sheer Broad Spectrum Sunscreen Lotion SPF 100 (050428415528) 050428616062 7470720B 2022-03 < 0.1
CVS Health Lotion 70 Beach Guard Sun Sunscreen SPF 70 050428402528 5980339C 2022-01 < 0.1
Max Block Lotion Sunscreen Lotion 4 Fl Oz Broad Spectrum Water Resistant SPF 30 639277292865 91047 2022-01 < 0.1
Walgreens Lotion Broad Spectrum Sport SPF 50 Sunscreen 049022977471 4440660B 2022-03 < 0.1
CVS Health Lotion Ultra Sheer Broad Spectrum Sunscreen Lotion SPF 100 (050428415528) 050428616062 1362040A 2022-07 < 0.1
TopCare Everyday Lotion Sport Sunscreen Lotion SPF 70 036800456303 0440090A 2023-01 < 0.1
Max Block Lotion Sport Sunscreen Lotion Water Resistance Blue 30 SPF 639277292063 00189 2022-03 < 0.1
Walgreens Lotion Sunscreen Sport SPF 50 049022977457 3232629A 2021-09 < 0.1
Max Block Lotion Sunscreen Lotion 4 Fl Oz Broad Spectrum Water Resistant SPF 30 639277292865 91188 2021-12 < 0.1
Max Block Lotion Sunscreen Lotion 4 Fl Oz Broad Spectrum Water Resistant SPF 30 639277292865 91188B 2021-12 < 0.1
Banana Boat Spray Kids Sport Sunscreen Lotion Spray SPF 50 079656020526 192546543 2022-08 < 0.1
TopCare Everyday Lotion Ultimate Sheer Sun Lotion Sunscreen SPF 55 036800456242 9543129A 2021-11 < 0.1
Solimo Lotion Sheer Face Sunscreen Lotion SPF 55 (842379152474 UPC Description) 842379167430 0495376 2022-07 < 0.1
Max Block Lotion Sport Sunscreen Lotion Water Resistance Blue 30 SPF 639277292063 91051 2022-02 < 0.1
Walgreens Lotion Sunscreen Sport SPF 50 049022977457 3222629B 2021-09 < 0.1
Neutrogena Lotion Sheer Zinc Dry-Touch Face Sunscreen SPF 50 086800110811 2979L1236 2022-03 < 0.1
CVS Health Spray Sport Clear Spray Sunscreen SPF 100+ 050428618868 7062049B 2021-07 < 0.1
La Roche-Posay Spray Anthelios Sunscreen Lotion Spray SPF 60 883140500841 201401230 2022-02 < 0.1
Banana Boat Spray Simply Protect Kids Sunscreen Spray SPF 50+ 079656024500 193639916 2022-11 < 0.1
Equate Lotion Kids Broad Spectrum Sunscreen Lotion, SPF 50 681131002462 3941300A 2023-05 < 0.1
CVS Health Spray Sheer Mist Spray Broad Spectrum Uva/Uvb Cont. Spray Sunscreen SPF 70 050428449240 2700189A 2022-01 < 0.1
Max Block Lotion Sport Sunscreen Lotion Water Resistance Blue 30 SPF 639277292063 91186 2021-12 < 0.1
Neutrogena Spray Ultra Sheer Weightless Sunscreen Spray, SPF 70 086800100409 32318F63 2021-10 < 0.1
Sun Bum Lotion Oxy Free Zinc Oxide Sunscreen Lotion – SPF 50 871760003903 S9351AN 2021-12 < 0.1
Aveeno Lotion Baby Continuous Protection Sensitive Skin Sunscreen Lotion Broad Spectrum SPF 50 381371164509 2419L1022 2022-02 < 0.1
Sun Bum Spray After Sun Cool Down Aloe Vera Spray 871760003187 S1039D < 0.1
Walgreens Gel After Sun Gel 049022507326 0701970A < 0.1
Up & Up Gel Clear Aloe Vera Gel 371661826163 9701930A < 0.1

Approved and released by the Canadian Dermatology Association 15 July 2021