FDA.reportPublic FDA data

BANANA BOAT

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:42:15

Label at a glance#

ProductBANANA BOAT
Active ingredientOCTOCRYLENE, AVOBENZONE, OCTISALATE
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 aging caused by the sun.

Dosage and administration

Shake well • 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 inclu...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.7%, Octisalate 4.5%, Octocrylene 5.2%

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 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 if

OTC - STOP USE SECTION

• 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

Shake well • 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Carthamus Tinctorius (Safflower) Seed Oil, C12-15 Alkyl Benzoate, Oryza Sativa (Rice) Starch, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Alcohol Denat., Phenoxyethanol, Caprylyl Glycol, Carbomer, Chlorphenesin, Sodium Hydroxide, Gluconolactone, Xanthan Gum, Disodium EDTA, Mangifera Indica (Mango) Seed Butter, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate

Other Information

SPL UNCLASSIFIED SECTION

• protect this product from excessive heatand direct sun

Questions or Comments?

OTC - STOP USE SECTION

Call 1-800-SafeSun, Mon-Fri

Package Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!

BANANA BOAT

baby

BROAD SPECTRUM SPF50 UVA/UVB

SUNSCREEN LOTION

50+

GENTLE ON SKIN

WON'T RUN INTO EYES

NO OXYBENZONE OR DYES

FRAGRANCE FREE

PEDIATRICIAN TESTED

WATER RESISTANT

(80 MINUTES)

6 FL.OZ. (177mL)

Front annd Back LabelFront annd Back Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-851-54BANANA BOAT177 g in 1 BOTTLELOTION1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-851BANANA BOAT (AVOBENZONE,OCTISALATE,OCTOCRYLENE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]1Current NDC, 1 package rows20241213_28f08236-1f01-d759-e063-6294a90adcfa.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-85163354-851-54

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
MANGIFERA INDICA (MANGO) SEED BUTTER4OXD9M35X2IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
PANTHENOLWV9CM0O67ZIACT
OCTOCRYLENE5A68WGF6WMACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
AVOBENZONEG63QQF2NOXACTIB
ORYZA SATIVA (RICE) STARCH4DGK8B7I3SIACT
XANTHAN GUMTTV12P4NEEIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL65UEH262ISIACT
CARBOMER0A5MM307FCIACT
CHLORPHENESINI670DAL4SZIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
OCTISALATE4X49Y0596WACTIB
ALOE BARBADENSIS LEAF JUICEZY81Z83H0XIACT
EDETATE DISODIUM7FLD91C86KIACT
ALCOHOL3K9958V90MIACT
SODIUM HYDROXIDE55X04QC32IIACT
GLUCONOLACTONEWQ29KQ9POTIACT

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,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC28f08236-1f01-d759-e063-6294a90adcfa2024-12-10WarningsExact identifier
ndc (package): 63354-851-54
ndc (product): 63354-851
ndc11 (package): 63354085154
spl id: 28f08236-1f02-d759-e063-6294a90adcfa
spl set id: 28f08236-1f01-d759-e063-6294a90adcfa

Reported adverse events (FAERS/openFDA)#

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