FDA.reportPublic FDA data

Banana Boat

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2024-10-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:30:46

Label at a glance#

ProductBanana Boat
Active ingredientHOMOSALATE, OCTOCRYLENE, AVOBENZONE
Label structure10 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 aging 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. • Do not apply in windy conditions • Use in well-ventilated area • Reapply: after 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months: Ask a doctor Sun Protection Measures ....

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.0%, Homosalate 6.0%, Octocrylene 6.0%

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 aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only

Flammable

WARNINGS AND PRECAUTIONS SECTION

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.

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 Poison Control Center right away.

May stain

SPL UNCLASSIFIED SECTION

some fabrics.

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. • Do not apply in windy conditions • Use in well-ventilated area • Reapply: after 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months: Ask a doctor
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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BANANA BOAT®

NEW!

hair & scalp defense

CLEAN SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 30

30

Lightweight

Non-Greasy

PROTECTION FOR HAIR & SCALP

Won't Dry Out Hair

Water Resistant

(80 minutes)

NET WT 6 OZ. (170 g)

63354-379-3463354-379-34

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-379-34Banana Boat170 g in 1 BOTTLE, SPRAYSPRAY1702

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-379BANANA BOAT (AVOBENZONE, HOMOSALATE, OCTOCRYLENE) SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]2Current NDC, Legacy NDC, 1 package rows20241029_8b889b75-07ac-4276-e053-2a95a90a69c6.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-37963354-379-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
ISOBUTANEBXR49TP611IACT
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALCOHOL3K9958V90MIACT
ISODODECANEA8289P68Y2IACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT

Source Document#

Source XML

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 LLC8b889b75-07ac-4276-e053-2a95a90a69c62024-10-27WarningsExact identifier
ndc (package): 63354-379-34
ndc (product): 63354-379
ndc11 (package): 63354037934
spl id: 25818787-6589-18ec-e063-6294a90adcc9
spl set id: 8b889b75-07ac-4276-e053-2a95a90a69c6

Reported adverse events (FAERS/openFDA)#

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