BANANA BOAT 23.8 g/100g

ZINC OXIDE · STICK · Edgewell Personal Care Brands LLC

2 Recalls on Record

Plain English

BANANA BOAT is a stick containing zinc oxide at 23.8 g/100g, taken topical. Manufactured by Edgewell Personal Care Brands LLC.

Key Facts

Brand Name: BANANA BOAT
Generic Name: ZINC OXIDE
NDC Code (Product): 63354-164
Manufacturer: Edgewell Personal Care Brands LLC
Strength: 23.8 g/100g
Dosage Form: STICK
Route: TOPICAL
Marketing Status
Application #: M020
Marketing Start: 10/01/2023

Recall History

2 Recalls on Record

Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Class I07/29/2022

Edgewell Personal Care Brands, LLC

Chemical contamination: presence of benzene

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective509 reports

macular degeneration453 reports

off label use314 reports

pyrexia305 reports

pain286 reports

nausea285 reports

malaise259 reports

weight decreased235 reports

therapeutic product effect incomplete213 reports

headache203 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • helps prevent sunburn • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage & Administration

Directions • apply liberally 15 minutes before sun exposure • reapply: after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.–2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor

Warnings

Warnings For external use only May stain some fabrics. Do not use on damaged or broken skin. When using this product • Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is BANANA BOAT used for?

BANANA BOAT contains ZINC OXIDE. It is a stick taken topical. Consult your doctor for specific uses.

Is BANANA BOAT a controlled substance?

BANANA BOAT is not classified as a controlled substance by the DEA.

What is the generic name for BANANA BOAT?

The generic name for BANANA BOAT is ZINC OXIDE. There are 12 other brand versions of ZINC OXIDE.

What is the NDC code for BANANA BOAT 23.8 g/100g?

The NDC (National Drug Code) for BANANA BOAT 23.8 g/100g is 63354-164, listed by Edgewell Personal Care Brands LLC.

Product NDC

63354-164

Package NDC

63354-164-61

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)