FDA Citizen Petition #5: Benzene in Sunscreens

On May 25, 2021, Valisure announced our detection of high levels of benzene, a known human carcinogen, in several brands and batches of sunscreen, which are considered drug products by the Food and Drug Administration (FDA), as well as in after-sun care products, which FDA generally regulates as cosmetics.

Valisure analyzed 294 unique batches from 69 different companies. Even within a single company, significant variability from batch to batch was observed. Fourteen lots of sunscreen and after-sun care products from four other brands contained between 2.78 – 6.26 ppm of benzene; 26 lots from eight brands included detectable benzene between 0.11 – 1.99 ppm; and 38 lots from 17 brands contained detectable benzene at < 0.1 ppm. Benzene was not detected in an additional 217 batches of sunscreen from 66 different brands through initial analysis of at least one sample. Benzene contamination was detected in sprays, gels, and lotions with chemical and mineral-based formulations.

These benzene results in sunscreens resulted in the recalls of Johnson & Johnson's Neutrogena products and Coppertone's products.

Complete Valisure FDA Citizen Petition Documents:

  • Full Citizen Petition – Contains lists of products where benzene was detected.
  • Attachment A – Contains a list of products where benzene was not detected.
  • Attachment B – Resolution from the American College of Cardiology regarding independent testing.

Media highlights:

FDA Citizen Petition #5: Benzene in Sunscreens

April 13, 2022

On May 25, 2021, Valisure announced our detection of high levels of benzene, a known human carcinogen, in several brands and batches of sunscreen, which are considered drug products by the Food and Drug Administration (FDA), as well as in after-sun care products, which FDA generally regulates as cosmetics.

Valisure analyzed 294 unique batches from 69 different companies. Even within a single company, significant variability from batch to batch was observed. Fourteen lots of sunscreen and after-sun care products from four other brands contained between 2.78 – 6.26 ppm of benzene; 26 lots from eight brands included detectable benzene between 0.11 – 1.99 ppm; and 38 lots from 17 brands contained detectable benzene at < 0.1 ppm. Benzene was not detected in an additional 217 batches of sunscreen from 66 different brands through initial analysis of at least one sample. Benzene contamination was detected in sprays, gels, and lotions with chemical and mineral-based formulations.

These benzene results in sunscreens resulted in the recalls of Johnson & Johnson's Neutrogena products and Coppertone's products.

Complete Valisure FDA Citizen Petition Documents:

  • Full Citizen Petition – Contains lists of products where benzene was detected.
  • Attachment A – Contains a list of products where benzene was not detected.
  • Attachment B – Resolution from the American College of Cardiology regarding independent testing.

Media highlights:

FDA Citizen Petition #5: Benzene in Sunscreens

On May 25, 2021, Valisure announced our detection of high levels of benzene, a known human carcinogen, in several brands and batches of sunscreen, which are considered drug products by the Food and Drug Administration (FDA), as well as in after-sun care products, which FDA generally regulates as cosmetics.

Valisure analyzed 294 unique batches from 69 different companies. Even within a single company, significant variability from batch to batch was observed. Fourteen lots of sunscreen and after-sun care products from four other brands contained between 2.78 – 6.26 ppm of benzene; 26 lots from eight brands included detectable benzene between 0.11 – 1.99 ppm; and 38 lots from 17 brands contained detectable benzene at < 0.1 ppm. Benzene was not detected in an additional 217 batches of sunscreen from 66 different brands through initial analysis of at least one sample. Benzene contamination was detected in sprays, gels, and lotions with chemical and mineral-based formulations.

These benzene results in sunscreens resulted in the recalls of Johnson & Johnson's Neutrogena products and Coppertone's products.

Complete Valisure FDA Citizen Petition Documents:

  • Full Citizen Petition – Contains lists of products where benzene was detected.
  • Attachment A – Contains a list of products where benzene was not detected.
  • Attachment B – Resolution from the American College of Cardiology regarding independent testing.

Media highlights:

On May 25, 2021, Valisure announced our detection of high levels of benzene, a known human carcinogen, in several brands and batches of sunscreen, which are considered drug products by the Food and Drug Administration (FDA), as well as in after-sun care products, which FDA generally regulates as cosmetics.

Valisure analyzed 294 unique batches from 69 different companies. Even within a single company, significant variability from batch to batch was observed. Fourteen lots of sunscreen and after-sun care products from four other brands contained between 2.78 – 6.26 ppm of benzene; 26 lots from eight brands included detectable benzene between 0.11 – 1.99 ppm; and 38 lots from 17 brands contained detectable benzene at < 0.1 ppm. Benzene was not detected in an additional 217 batches of sunscreen from 66 different brands through initial analysis of at least one sample. Benzene contamination was detected in sprays, gels, and lotions with chemical and mineral-based formulations.

These benzene results in sunscreens resulted in the recalls of Johnson & Johnson's Neutrogena products and Coppertone's products.

Complete Valisure FDA Citizen Petition Documents:

  • Full Citizen Petition – Contains lists of products where benzene was detected.
  • Attachment A – Contains a list of products where benzene was not detected.
  • Attachment B – Resolution from the American College of Cardiology regarding independent testing.

Media highlights:

SIGN UP FOR THE VALISURE NEWSLETTER 

Sign up to stay updated with Valisure announcements, relevant industry news, company updates, and more. 

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.