Products Recalled:Banana Boat, Hair & Scalp Spray SPF 30
Edgewell Personal Care Company (NYSE: EPC), which produced three batches of Banana Boat Hair & Scalp Sunscreen Spray SPF 30, has increased its voluntary nationwide recall to the consumer level. The original recall announced on July 29, 2022, has been expanded to include one more batch of Bana Boat Sunscreen.
A study revealed that some Banana Boat Sunscreen Spray samples contained benzene in trace amounts. Although benzene is not a component in any goods made by Banana Boat, the investigation revealed that the propellant used to spray the product from the container produced unexpectedly high quantities of benzene.
Scientific Evidence:
Benzene is considered a human carcinogen, which can lead to malignancies like leukaemia, blood cancers of the bone marrow, and possibly fatal blood diseases. A person can be exposed to benzene by inhaling, ingesting, or applying it topically.
No adverse events about the SPF 30 sunscreen spray have yet been reported to Edgewell. Humans can be exposed to benzene every day from multiple sources. An independent health assessment using recognised exposure modelling criteria concluded that daily exposure to benzene in the recalled products would not be expected to induce harmful health effects [1].
What Regulations Clarifies:
- Sunscreens are monitored by the FDA, which specifies regulations on the SPF, dosage forms and spectrum specification (protection from UVA and UVB rays).
- Benzene can be incorporated in sprays by propellant. The FDA monitors benzene in drugs and pharmaceutical products and initiates product recall if benzene is discovered in the product.
- The International Conference on Harmonisation (ICH) has laid a Q3C guidance on solvents. It specifies that benzene should not be included in the manufacture of drugs, and if it is unavoidable, the benzene concentration should not exceed two parts per million (ppm).
- Manufacturers should test their products for benzene and not release any product with a benzene concentration exceeding two parts per million.