The online pharmacy and independent testing company Valisure discovered the presence of the human carcinogen N-nitrosodimethylamine (NDMA) in Valsartan and Zantac and recently alerted the FDA to the presence of the human carcinogen benzene in many popular sunscreens.

Valisure’s Citizen Petition

 On May 24, 2021, Valisure filed a Citizen Petition with the U.S. Food and Drug Administration about its findings. As a result of the alarming levels of benzene discovered in a wide variety of sunscreens, including sprays and lotions, Valisure requested that the FDA “issue regulations, request recalls, revise industry guidance, and take other requested actions.”

Valisure tested and detected high levels of benzene in specific batches of sunscreen products containing active pharmaceutical ingredients, including: 

  • Avobenzone
  • Oxybenzone
  • Octisalate
  • Octinoxate
  • Homosalate
  • Octocylene
  • Zinc oxide

The Centers for Disease Control and Prevention (CDC) stated that the Department of Health and Human Services (HHS) determined that benzene can cause cancer in humans. The National Institute for Occupational Safety and Health recommends that workers wear protective equipment if they are going to be exposed to benzene at a concentration of 0.1 ppm because exposure can occur through “inhalation, skin absorption, ingestion, skin and/or eye contact.”

 The World Health Organization (WHO) and the International Agency for Research on Cancer (IARC) classified benzene as a Group 1 compound, which means that it is carcinogenic to humans based on sufficient evidence that benzene can cause acute myeloid leukemia (AML). IARC also noted that benzene exposure has been linked to acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), multiple myeloma, and non-Hodgkin lymphoma. Since benzene is associated with blood cancers such as leukemia, the fact that sunscreen’s ingredients are absorbed through the skin and into the bloodstream is especially concerning. The Citizen Petition stated: “The presence of this known human carcinogen in sunscreen products widely recommended for the prevention of skin cancer and regularly used by adults and children in large volumes makes this finding especially troubling.” 

The FDA also classifies benzene as a Class 1 solvent, stating that it “should not be employed in the manufacture of drug substances, excipients, and drug products because of their unacceptable toxicity…However, if their use is unavoidable in order to produce a drug product with a significant therapeutic advance, then their levels should be restricted.” The current benzene restriction is two parts per million (ppm). Although the current benzene restriction is 2 ppm, Valisure’s test results revealed that many sunscreens contained amounts of benzene well in excess of this limit.

Valisure provided the results of its testing in its Citizen Petition and included a list of sunscreens which did not contain detectable levels of benzene, demonstrating that sunscreen can be and is produced without unsafe levels of benzene.

Sunscreens with Benzene

Valisure’s testing detected benzene in the following sunscreens from various retailers: 

Neutrogena ***Benzene detected at 2 ppm or higher 

  • Ultra Sheer Weightless Sunscreen Spray, SPF 100+
  • Ultra Sheer Weightless Sunscreen Spray, SPF 70
  • Beach Defense Oil-Free Body Sunscreen Spray, SPF 100
  • Invisible Daily Defense Body Sunscreen Broad Spectrum, SPF 60+
  • Beach Defense Spray Body Sunscreen, SPF 50
  • CoolDry Sport Water-Resistant Sunscreen Spray, SPF 70
  • CoolDry Sport Water-Resistant Sunscreen Spray, SPF 50
  • Ultra Sheer Body Mist Sunscreen Broad Spectrum, SPF 30 Spray
  • Ultra Sheer Body Mist Sunscreen Broad Spectrum, SPF 45
  • Ultra Sheer Dry-Touch Water Resistant Sunscreen, SPF 70
  • Sheer Zinc Dry-Touch Face Sunscreen, SPF 50 

CVS Health ***Benzene detected at 2 ppm or higher

  • After-Sun Aloe Vera Soothing Spray 
  • Body Mineral Spray Sunscreen, SPF 50
  • Ultra Sheer Broad Spectrum Sunscreen Lotion, SPF 100 
  • Ultra Sheer Lotion Broad Spectrum Sunscreen, SPF 45
  • 70 Beach Guard Sun Sunscreen, SPF 70
  • Sport Clear Spray Sunscreen, SPF 100+
  • Sheer Mist Spray Broad Spectrum Uva/Uvb Cont. Spray Sunscreen, SPF 70

Sun Bum ***Benzene detected at 2 ppm or higher

  • Cool Down Gel 
  • Oxy Free Zinc Oxide Sunscreen Lotion, SPF 50 
  • After Sun Cool Down Aloe Vera Spray 

Fruit of the Earth ***Benzene detected at 2 ppm or higher 

  • Aloe Vera Gel 

Walgreens

  • Sport Lotion Sunscreen, SPF 50
  • Broad Spectrum Sport, SPF 50 Sunscreen 
  • Sunscreen Sport, SPF 50
  • After Sun Gel 

SunBurnt

  • Advanced After-Sun Gel 

Goodsense

  • Sunscreen Lotion, SPF 30

Banana Boat 

  • Kids Max Protect & Play Sunscreen C-Spray, SPF 100 
  • UltraMist Deep Tanning Dry Oil Continuous Clear Spray, SPF 4
  • Ultra Sport Clear Sunscreen Spray, SPF 100
  • Protective Dry Oil Clear Sunscreen Spray with Coconut Oil, SPF 15 
  • Ultra Defense Ultra Mist Clear Sunscreen Spray, SPF 100 
  • Kids Sport Sunscreen Lotion Spray, SPF 50 
  • Simply Protect Kids Sunscreen Spray, SPF 50+ 

Max Block

  • Sunscreen Lotion 4 Fl Oz Broad Spectrum Water Resistant, SPF 30
  • Sport Sunscreen Lotion Water Resistant Blue, SPF 30 

Raw Elements

  • Eco Formula Sunscreen Lotion, SPF 30

TopCare Everyday

  • Ultimate Sheer Sunscreen Lotion, SPF 70
  • Ultimate Sheer Sun Lotion Sunscreen, SPF 55
  • Sport Sunscreen Lotion, SPF 70

EltaMD

  • UV Aero Broad-Spectrum Full-Body Sunscreen Spray, SPF 45

Solimo

  • Sheer Face Sunscreen Lotion, SPF 55

Aveeno

  • Baby Continuous Protection Sensitive Skin Sunscreen Lotion Broad Spectrum, SPF 50

Coppertone

  • Whipped Sunscreen Lotion Spray, SPF 50

Ethical Zinc

  • Natural Clear Zinc Sunscreen SPF 50+

Babyganics

  • Kids Sunscreen Continuous Spray, SPF 50

La Roche Posay 

  • Anthelios Sunscreen Lotion Spray, SPF 60

Equate

  • Kids Broad Spectrum Sunscreen Lotion, SPF 50

Up & Up 

  • Clear Aloe Vera Gel 

Action Requested from the FDA

In their Citizen Petition, Valisure requested multiple actions from the FDA to amend the problem. Valisure requested that the FDA request recalls for the identified batches of sunscreens containing the benzene to protect public safety. In addition to the recalls, Valisure also wants the FDA to–at minimum–substantially lower the limit of 2 ppm of benzene because benzene should not be used at any point in manufacturing sunscreen. However, Valisure thinks that the FDA should go even further and revise the  rule to say that benzene “should not be employed in the manufacture of drug substances.” This would make it clear there is no acceptable level of benzene in consumer products such as sunscreen and after-sun care products. 

Currently, the FDA does not have any guidance on a permissible daily exposure for benzene in any drug product (including sunscreen) or cosmetic product (after-sun care products). Valisure urgently requests the FDA mandates a constant permissible daily intake or exposure limit due to the variability in product sizes and exposures per day that are common with an individual’s application of sunscreen and after-sun care products. This would guide users on the amount of sunscreen to use per application and how many daily applications are safe. 

Valisure requested that the FDA create rules or issue administrative orders requiring “independent batch-level testing and verification of sunscreen products” that are regulated as drugs by the FDA and/or revise the FDA’s proposed sunscreen rule in the Federal Register. In the meantime, Valisure urged the FDA to issue formal guidance recommending testing and verification to “serve public health and help protect Americans from adulterated drug products, an issue of growing concern.”

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