FDA.reportPublic FDA data

Banana Boat

Manufacturer
Edgewell Personal Care Brands, LLC
Effective date
2024-11-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:39:20

Label at a glance#

ProductBanana Boat
Active ingredientOCTISALATE, AVOBENZONE, 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 aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure • 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...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

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

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 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure • 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

Water, Diisopropyl Adipate, Silica, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Tapioca Starch, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexlyglycerin, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Chlorphenesin, Xanthan Gum, Sodium Hydroxide, Disodium EDTA, Fragrance, Polymethylsilsesquioxane, Tocopheryl Acetate, Sodium Ascorbyl Phosphate, Panthenol, Aloe Barbadensis Leaf Juice

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BANANA BOAT®
Light as air
SUNSCREEN LOTION
UVA/UVB BROAD SPECTRUM SPF 50+
50+
Weightless
Protection
ABSORBS QUICKLY &
NON-GREASY
Water Resistant
(80 Minutes)
6 FL.OZ. (177 mL)

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-481-21Banana Boat29 g in 1 TUBELOTION296
63354-481-24Banana Boat177 g in 1 TUBELOTION1776
63354-481-27Banana Boat270 g in 1 TUBELOTION2706

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-481BANANA BOAT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [EDGEWELL PERSONAL CARE BRANDS, LLC]6Current NDC, Legacy NDC, 3 package rows20241127_8a1eefa6-619e-5d02-e053-2995a90a3d75.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-48163354-481-21, 63354-481-24, 63354-481-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHLORPHENESINI670DAL4SZIACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Z570VEV8XKIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
COCO GLUCOSIDEICS790225BIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
ALOE VERA LEAFZY81Z83H0XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
STARCH, TAPIOCA24SC3U704IIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PANTHENOLWV9CM0O67ZIACT
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
AVOBENZONEG63QQF2NOXACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE DISODIUM7FLD91C86KIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands, LLC8a1eefa6-619e-5d02-e053-2995a90a3d752024-11-25WarningsExact identifier
ndc (package): 63354-481-27
ndc (package): 63354-481-24
ndc (package): 63354-481-21
ndc (product): 63354-481
ndc11 (package): 63354048127
ndc11 (package): 63354048124
ndc11 (package): 63354048121
spl id: 27c51ad3-5f8e-032d-e063-6394a90a4860
spl set id: 8a1eefa6-619e-5d02-e053-2995a90a3d75

Reported adverse events (FAERS/openFDA)#

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