FDA.reportPublic FDA data

Banana Boat

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2024-10-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:30:46

Label at a glance#

ProductBanana Boat
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure9 sections

Indications and uses

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

Dosage and administration

• Shake well • hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • do not spray directly into face . Spray on hands then apply to face • do not apply in windy conditions • use in well-ventialated area • repply: • after 80 minutes of swimming or sweating, immediately after towel drying • at least every 2 hours. Sun Protection Measures . Sp...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avoebenzone 1.6%, Homosalate 4.0%, Octocrylene 4.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Flammable: Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F. Do not use in the presence of a flame or spark. Keep away from sources of ignition – No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

May stain some fabrics.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

• Keep away from face to avoid breathing it • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Posion Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Shake well • hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • do not spray directly into face. Spray on hands then apply to face • do not apply in windy conditions • use in well-ventialated area • repply: • 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 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-sleeve shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat., Isobutane, Isododecane, Diisopropyl Adipate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Fragrance, Tocopheryl Acetate.

Other Information

SPL UNCLASSIFIED SECTION

• protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call 1 800 SafeSun, Mon-Fri

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BANANA
BOAT®
SPORT
ultra
CLEAR SUNSCREEN SPRAY
BROAD SPECTRUM SPF 15
15
CLINICALLY
PROVEN
UVA/UVB PROTECTION
SUPERIOR ENDURANCE
VS. SWEAT & WATER
FREE FROM
Oxybenzone
Octinoxate
Water Resistant
(80 Minutes)
NET WT 6 OZ. (170 g)

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-361-34Banana Boat170 g in 1 CANSPRAY1703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-361BANANA BOAT (AVOBENZONE, HOMOSALATE, OCTOCRYLENE) SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]3Current NDC, Legacy NDC, 1 package rows20241029_7961ff9f-75db-4977-e053-2a91aa0ae628.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-36163354-361-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOBENZONEG63QQF2NOXACTIB
CAPRYLYL GLYCOL00YIU5438UIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
DIISOPROPYL ADIPATEP7E6YFV72XIACT
ALCOHOL3K9958V90MIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ISOBUTANEBXR49TP611IACT
ISODODECANEA8289P68Y2IACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Banana BoatAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC7961ff9f-75db-4977-e053-2a91aa0ae6282024-10-27WarningsExact identifier
ndc (package): 63354-361-34
ndc (product): 63354-361
ndc11 (package): 63354036134
spl id: 25816f95-a6a4-a676-e063-6394a90a2d52
spl set id: 7961ff9f-75db-4977-e053-2a91aa0ae628

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.