Sunscreen FDA Alerts

Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene – UPDATED

SHELTON, Conn., January 27, 2023 – Edgewell Personal Care Company (NYSE: EPC) today expanded its voluntary nationwide recall of three batches of Banana Boat Hair & Scalp Sunscreen Spray SPF 30 to the consumer level as outlined in the table below. One additional batch has been added to the original recall announced on July 29, 2022.

A review found that some samples of the product contained trace levels of benzene. While benzene is not an ingredient in any Banana Boat products, the review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can.

Importantly, no other batches of Hair & Scalp (either before or after these batch codes) and no other Banana Boat products are in the scope of this recall and may continue to be used by consumers safely and as intended.

Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening. To date, Edgewell has not received any adverse events related to this recall. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources. Daily exposure to benzene in the recalled products would not be expected to cause adverse health consequences according to an independent health assessment using established exposure modeling guidelines.

The voluntarily recalled sunscreen spray products are packaged in aerosol cans. The products were distributed nationwide in the United States through various retailers and online. Edgewell has notified its retailers to remove any remaining recalled product from shelves. Banana Boat will also offer reimbursement for consumers who have purchased a product marked with one of the lot codes in the table above. Lot codes are located on the bottom of the can. Consumers should stop using the affected product immediately and appropriately discard.

Consumers with questions regarding this recall may contact Edgewell Personal Care at 1-888-686-3988 Monday through Friday, 9:00 a.m. to 6:00 p.m. Eastern Time. Consumers may also visit www.bananaboat.com for more information and to learn how to receive reimbursement for eligible products. Consumers should contact their physician or healthcare provider if they have any questions, concerns or have experienced any problems related to using these aerosol sunscreen products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Edgewell

Edgewell is a leading pure-play consumer products company with an attractive, diversified portfolio of established brand names including Schick® and Wilkinson Sword® men's shaving products; Schick® and Billie® women's shaving products; Edge® and Skintimate® shave preparations; Playtex®, Stayfree®, Carefree® and o.b.® feminine care products; Banana Boat® and Hawaiian Tropic® sun care products; Bulldog®, Jack Black® and Cremo® grooming products; Fieldtrip™ skin care products; and Wet Ones® hygiene products. The Company has a broad global footprint and operates in more than 50 markets, including the U.S., Canada, Mexico, Germany, Japan, the U.K. and Australia, with approximately 6,500 employees worldwide.

Original Press Release

Source: FDA

Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene

SHELTON, Conn., July 29, 2022 – Edgewell Personal Care Company (NYSE: EPC) today issued a voluntary nationwide recall of three batches of Banana Boat Hair & Scalp Sunscreen Spray SPF 30 to the consumer level as outlined in the table below. An internal review found that some samples of the product contained trace levels of benzene. While benzene is not an ingredient in any Banana Boat products, the review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can.

Importantly, no other batches of Hair & Scalp (either before or after these batch codes) and no other Banana Boat products are in the scope of this recall and may continue to be used by consumers safely and as intended.

Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening. To date, Edgewell has not received any adverse events related to this recall. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources. Daily exposure to benzene in the recalled products would not be expected to cause adverse health consequences according to an independent health assessment using established exposure modeling guidelines.

The voluntarily recalled sunscreen spray products are packaged in aerosol cans. The products were distributed nationwide in the United States through various retailers and online. Edgewell has notified its retailers to remove any remaining recalled product from shelves. Banana Boat will also offer reimbursement for consumers who have purchased a product marked with one of the lot codes in the table above. Lot codes are located on the bottom of the can. Consumers should stop using the affected product immediately and appropriately discard.

Consumers with questions regarding this recall may contact Edgewell Personal Care at 1-888-686-3988 Monday through Friday, 9:00 a.m. to 6:00 p.m. Eastern Time. Consumers may also visit www.bananaboat.com for more information and to learn how to receive reimbursement for eligible products. Consumers should contact their physician or healthcare provider if they have any questions, concerns or have experienced any problems related to using these aerosol sunscreen products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Edgewell

Edgewell is a leading pure-play consumer products company with an attractive, diversified portfolio of established brand names including Schick® and Wilkinson Sword® men's shaving products; Schick® and Billie® women's shaving products; Edge® and Skintimate® shave preparations; Playtex®, Stayfree®, Carefree® and o.b.® feminine care products; Banana Boat® and Hawaiian Tropic® sun care products; Bulldog®, Jack Black® and Cremo® grooming products; Fieldtrip™ skin care products; and Wet Ones® hygiene products. The Company has a broad global footprint and operates in more than 50 markets, including the U.S., Canada, Mexico, Germany, Japan, the U.K. and Australia, with approximately 6,500 employees worldwide.

Source: FDA

Coppertone® Issues Voluntary Nationwide Recall of Specific Lots of Aerosol Sunscreen Spray Products Due to the Presence of Benzene

September 30, 2021 -- Coppertone, owned by Beiersdorf, is voluntarily recalling specific lots of five Coppertone aerosol sunscreen spray products manufactured between the dates of January 10, 2021 and June 15, 2021 to the consumer level. Coppertone has identified the presence of benzene in these lots of products

Twelve lots of Coppertone spray products are impacted by this voluntary recall, specifically:

For product images, lot information, and refund requests, please see www.sunscreenrecall2021.com.

Benzene is classified as a human carcinogen. Exposure to benzene can occur through inhalation, oral, and skin and it could, depending on the level and extent of exposure, result in an increased risk of cancers including leukemia, and blood cancer of the bone marrow and other blood disorders which can be life-threatening.

Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies.

Out of an abundance of caution, we are recalling certain lots of these specific aerosol sunscreen spray products. To date, Coppertone has not received any reports of adverse events related to this recall.

The voluntarily recalled sunscreen spray products are packaged in aerosol cans. The products were distributed nationally in the United States through various retailers. Consumers should stop using these specific Coppertone aerosol sunscreen spray products and dispose of them appropriately.

Beginning on September 30, 2021 at 5pm (EST), consumers may contact 1-888-921-1537 with questions Monday to Friday from 8:30am-5pm (PT). Consumers may also access www.sunscreenrecall2021.com to request a product refund and for additional information. Coppertone is also notifying its retailers by letter and is arranging for returns of all voluntarily recalled lots of sunscreen spray products. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these aerosol sunscreen spray products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

The FDA and other medical authorities recognize the public health benefits of sunscreens and strongly advise the use of sunscreen along with other protective measures from the sun.

Source: FDA

Johnson & Johnson Consumer Inc. Issues Voluntary Recall of Specific Neutrogena® and Aveeno® Aerosol Sunscreen Products Due to the Presence of Benzene

NEW BRUNSWICK, N.J., JULY 14, 2021 – Johnson & Johnson Consumer Inc. (JJCI) is voluntarily recalling all lots of five Neutrogena® and Aveeno® aerosol sunscreen product lines to the consumer level. Internal testing identified low levels of benzene in some samples of the products. Consumers should stop using the affected products and follow the instructions set forth below.

The only sunscreen products impacted are aerosol products, specifically:

Neutrogena® Beach Defense® aerosol sunscreen,
Neutrogena® Cool Dry Sport aerosol sunscreen,
Neutrogena® Invisible Daily™ defense aerosol sunscreen,
Neutrogena® Ultra Sheer® aerosol sunscreen, and
Aveeno® Protect + Refresh aerosol sunscreen.

Product images and lot information is available on www.Neutrogena.com and www.Aveeno.com.

Benzene is classified as a human carcinogen, a substance that could potentially cause cancer depending on the level and extent of exposure. Benzene is ubiquitous in the environment. Humans around the world have daily exposures indoors and outdoors from multiple sources. Benzene can be absorbed, to varying degrees, by inhalation, through the skin, and orally. Based on exposure modeling and the Environmental Protection Agency’s (EPA) framework, daily exposure to benzene in these aerosol sunscreen products at the levels detected in our testing would not be expected to cause adverse health consequences. Out of an abundance of caution, we are recalling all lots of these specific aerosol sunscreen products.

While benzene is not an ingredient in any of our sunscreen products, it was detected in some samples of the impacted aerosol sunscreen finished products. We are investigating the cause of this issue, which is limited to certain aerosol sunscreen products.

Sunscreen use is critical to public health. Melanoma incidences continue to increase worldwide, and the majority of cases are caused by excessive sun exposure. It is important that people everywhere continue to take appropriate sun protection measures, including the continued use of alternative sunscreen.

The recalled sunscreen products are packaged in aerosol cans. The products were distributed nationwide through a variety of retail channels.

Consumers should stop using these specific products and appropriately discard them. Consumers may contact the JJCI Consumer Care Center 24/7 with questions or to request a refund by calling 1-800-361-8068. Consumers should contact their physician or healthcare provider if they have any questions, concerns or have experienced any problems related to using these aerosol sunscreen products. JJCI is also notifying its distributors and retailers by letter and is arranging for returns of all recalled products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the voluntary recall of specific NEUTROGENA® and AVEENO® aerosol sunscreen products. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson Consumer Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; uncertainty of commercial success for new and existing products; the ability of the company to successfully execute strategic plans; manufacturing difficulties or delays, internally or within the supply chain; changes to applicable laws and regulations; changes in behavior and spending patterns of purchasers of health care products and services; and increased scrutiny of the health care industry by government agencies. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Johnson & Johnson Consumer Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. The Company expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.

Source: Johnson & Johnson

W.S. Badger Company Daily SPF 30 Kids & Baby Sunscreen Lotion: Recall - Microbial Contamination

ISSUE: W.S. Badger Co. Inc. notified the public that it is recalling all lots of its 4-ounce SPF 30 Baby Sunscreen Lotion and one lot of its 4-ounce SPF 30 Kids Sunscreen Lotion  due to microbial contamination. The products were tested and found to be contaminated with Pseudomonas aeruginosa, Candida parapsilosis and Acremonium fungi.

The affected lots include the following:
 

• SPF 30 Baby Sunscreen Lotion 4oz (UPC: 634084490091&634084490114) Lot #’s 3024A, 3057B, 3063A, 3063B, 3132A, 3133A
• SPF 30 Kids Sunscreen Lotion (UPC: 634084490145 & 634084490169) Lot # 3164A

BACKGROUND: Both sunscreens are sold in the USA & Canada online and at major retailers as well as independent food co-ops and pharmacies. The product can be identified by matching the UPC with the Lot code, which can be found on the top front of the tube crimp.

RECOMMENDATION: Consumers who have purchased the Sunscreen Lotion should not use these products and may return product to the original point of purchase for a full refund, or contact Badger directly at 1-800-603-6100 or email recalls@badgerbalm.com between the hours of 8:30-4:30 ET, Monday - Friday.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[09/23/2013 - Press Release - W.S. Badger Co. Inc]
[09/23/2013 - Product Photos - W.S. Badger Co. Inc]