FDA.reportPublic FDA data

Banana Boat

Manufacturer
Edgewell Personal Care Brands, LLC
Effective date
2022-11-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:51:43

Label at a glance#

ProductBanana Boat
Active ingredientHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
Label structure13 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply liberally 15 minutes before sun exposure; • Do not spray directly into face . Spray on hands and then apply to face. •Reapply: •after 80 minutes of swimming or sweating •immediately after towel drying •at least every 2 hours •Children under 6 months: Ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 4.5%, Octisalate 3.2%, Octocrylene 2.4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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. May stain some fabrics

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure; • Do not spray directly into face. Spray on hands and then apply to face. •Reapply: •after 80 minutes of swimming or sweating •immediately after towel drying •at least every 2 hours •Children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, C12-15 Alkyl Benzoate, Caprylyl Glycol, Diethylhexyl 2,6-Naphthalate, Isopropyl Myristate, Coconut Oil, Grape Seed Oil, Theobroma Cacao (Cocoa) Seed Butter (Cocoa Butter),Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Zea Mays (Corn) Oil, Aloe Barbadensis Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, Musa Sapientum (Banana) Fruit Extract,Phenoxyethanol, Fragrance.

Other Information

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun

Questions & comments?

OTC - QUESTIONS SECTION

Call 1-800-SafeSun, mon-fri

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BANANA

BOAT®

TANNING

SPRAY OIL

SUNSCREEN SPRAY SPF 8

8

WITH COCONUT OIL

Skin Nourishing Formula

Water Resistant

(80 Minutes)

8 FL. OZ. (236 mL)

X001008801 Front labelX001008801 Front label

X001008801 Back labelX001008801 Back label

BANANA

BOAT

Spray Oil

UVA/UVB PROTECTION SUNSCREEN

8

BROAD SPECTRUM SPF 8

CARROT & BANANA EXTRACTS

WATER RESISTANT (80 MINUTES)

SWIM SPLASH SPORT

63354410166335441016

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63354-410-162025-11-06C16284748780-12cef2736-8bce-d83d-e063-dadaa90ab31f47dd9d8a-0df3-6596-e054-00144ff88e88
63354-410-162025-01-30C16284748780-12cef2736-8bce-d83d-e063-dadaa90ab31f47dd9d8a-0df3-6596-e054-00144ff88e88

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-410BANANA BOAT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [EDGEWELL PERSONAL CARE BRANDS, LLC]4Legacy NDC20221122_47dd9d8a-0df3-6596-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-41063354-410-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
MINERAL OILT5L8T28FGPIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
COCONUT OILQ9L0O73W7LIACT
GRAPE SEED OIL930MLC8XGGIACT
THEOBROMA CACAO WHOLEEB048G1S9JIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
SUNFLOWER OIL3W1JG795YIIACT
CORN OIL8470G57WFMIACT
CARROTL56Z1JK48BIACT
BANANA4AJZ4765R9IACT
PHENOXYETHANOLHIE492ZZ3TIACT
AVOBENZONEG63QQF2NOXACTIB

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
42f031c2-6d28-b4a5-e063-6294a90a188d47dd9d8a-0df3-6596-e054-00144ff88e882025-11-06WarningsExact identifier
spl set id: 47dd9d8a-0df3-6596-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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