FDA.reportPublic FDA data

BANANA BOAT

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2018-10-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:49:27

Label at a glance#

ProductBANANA BOAT
Active ingredientOCTOCRYLENE, AVOBENZONE, HOMOSALATE
Label structure13 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decrease the risk of skin cancer and early skin aging caused by 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 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 ti...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 9.0%, 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), decrease the risk of skin cancer and early skin aging caused by sun.

Warnings

WARNINGS SECTION

For external use only

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 • 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, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Cetearyl Alcohol, Diisopropyl Adipate, Phenethyl Benzoate, Polymethylsilsesquioxane, Silica, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Dimethicone, Glycerin, Carbomer, Coco-Glucoside, Methylparaben, Ceteth-10 Phosphate, Dicetyl Phosphate, Propylparaben, Sodium Hydroxide, Fragrance, Disodium EDTA, Paraffin, Xanthan Gum, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Juice.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BANANA

BOAT

Sun

COMFORT

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

Sand Easily

Brushes Off

RELIEVES DRYNESS

High Endurance vs. Water

Water Resistant

(80 Minutes)

BB SPF 50+ LotionBB SPF 50+ Lotion

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63354-191-542024-01-17C16284748780-1d6a99b39-6934-a426-e053-dadaa90af4c2775a4242-9efb-256a-e053-2991aa0ae37a
63354-191-542022-01-28C16284748780-1d6a99b39-6934-a426-e053-dadaa90af4c2775a4242-9efb-256a-e053-2991aa0ae37a

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-19163354-191-54

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
PARAFFINI9O0E3H2ZEIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
COCO GLUCOSIDEICS790225BIACT
METHYLPARABENA2I8C7HI9TIACT
EDETATE DISODIUM7FLD91C86KIACT
OCTOCRYLENE5A68WGF6WMACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
PHENETHYL BENZOATE0C143929GKIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Z570VEV8XKIACT
CARBOMER 934Z135WT9208IACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
SODIUM HYDROXIDE55X04QC32IIACT
PROPYLPARABENZ8IX2SC1OHIACT
PANTHENOLWV9CM0O67ZIACT

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
0f2a8ef2-1523-1c1b-e063-6294a90a2c17775a4242-9efb-256a-e053-2991aa0ae37a2024-01-17WarningsExact identifier
spl set id: 775a4242-9efb-256a-e053-2991aa0ae37a

Reported adverse events (FAERS/openFDA)#

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