FDA.reportPublic FDA data

Banana Boat

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2017-06-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:15:20

Label at a glance#

ProductBanana Boat
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure13 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 prote...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 1.4%, Homosalate 3.0%, Octocrylene 3.0%

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

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 •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, Cetearyl Alcohol, Stearyl Alcohol, Glycerin, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Cetyl Alcohol, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Methylparaben, Coco-Glucoside, Xanthan Gum, Propylparaben, Sodium Hydroxide, Disodium EDTA, Lauryl PEG-8 Dimethicone, Methyl Dihydroabietate, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, 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

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BANANA

BOAT

SPORT

performance

with POWERSTAY

TECHNOLOGY™

sunscreen lotion

15

UVA/UVB PROTECTION

BROAD SPECTRUM SPF 15

LIGHTWEIGHT FEEL

WON'T RUN INTO EYES

WATER & SWEAT

REISISTANT (80 MINUTES)

SWIM • SPLASH • SPORT

63354139566335413956

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63354-139-562024-01-10C16284748780-1d6a99b39-4e60-a426-e053-dadaa90af4c245c34d1e-3f13-3712-e054-00144ff8d46c
63354-139-562022-01-28C16284748780-1d6a99b39-4e60-a426-e053-dadaa90af4c245c34d1e-3f13-3712-e054-00144ff8d46c

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-13963354-139-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
METHYLPARABENA2I8C7HI9TIACT
COCO GLUCOSIDEICS790225BIACT
PROPYLPARABENZ8IX2SC1OHIACT
ALOE VERA LEAFZY81Z83H0XIACT
HOMOSALATEV06SV4M95SACTIB
STEARYL ALCOHOL2KR89I4H1YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
CAPRYLYL GLYCOL00YIU5438UIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE DISODIUM7FLD91C86KIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
.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
0e9de272-054b-cef0-e063-6294a90ab4c645c34d1e-3f13-3712-e054-00144ff8d46c2024-01-10WarningsExact identifier
spl set id: 45c34d1e-3f13-3712-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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