FDA.reportPublic FDA data

Banana Boat

Manufacturer
Edgewell Personal Care Brands LLC | Playtex Manufacturing Inc
Effective date
2020-06-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:27:54

Label at a glance#

ProductBanana Boat
Active ingredientOCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure13 sections

Indications and uses

Helps prevent sunburn

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

Label contents#

Full prescribing information#

Active Ingredients

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

Warnings

WARNINGS SECTION

For external use only

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.

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. Keep away from face to avoid breathing it. 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

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, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Methylparaben, Fragrance, Xanthan Gum, Propylparaben, Sodium Hydroxide, Disodium EDTA, Polymethylsilsesquioxane, 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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Banana

Boat

Dry

Balance

Sunscreen Lotion

helps you feel

dry & fresh

50+

UVA/UVB PROTECTION

BROAD SPECTRUM SPF 50+

SOFT MATTE FINISH

SKIN BREATHES EASY

WATER RESISTANT

(80 MINUTES)

63354757546335475754

63354757566335475756

BANANA

BOAT(R)

NEW

LOOK!

DRY
Balance(TM)

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

Skin Feels

Fresh & Dry

SOFT MATTE FINISH

High Endurance vs. Water

Water Resistant

(80 Minutes)

6 FL. OZ. (177mL)

63354-757-5463354-757-54

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63354-757-542024-01-09C16284748780-1d6a99b39-3f2d-a426-e053-dadaa90af4c243796623-dc2a-1ab4-e054-00144ff88e88
63354-757-562024-01-09C16284748780-1d6a99b39-3f2d-a426-e053-dadaa90af4c243796623-dc2a-1ab4-e054-00144ff88e88
63354-757-542022-01-28C16284748780-1d6a99b39-3f2d-a426-e053-dadaa90af4c243796623-dc2a-1ab4-e054-00144ff88e88
63354-757-562022-01-28C16284748780-1d6a99b39-3f2d-a426-e053-dadaa90af4c243796623-dc2a-1ab4-e054-00144ff88e88

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-75763354-757-54, 63354-757-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
DIISOPROPYL ADIPATEP7E6YFV72XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCERINPDC6A3C0OXIACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
METHYLPARABENA2I8C7HI9TIACT
ALOE VERA LEAFZY81Z83H0XIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Z570VEV8XKIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
PANTHENOLWV9CM0O67ZIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STARCH, TAPIOCA24SC3U704IIACT
CAPRYLYL GLYCOL00YIU5438UIACT
COCO GLUCOSIDEICS790225BIACT
PROPYLPARABENZ8IX2SC1OHIACT

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
0e89609b-bd47-291f-e063-6294a90a623e43796623-dc2a-1ab4-e054-00144ff88e882024-01-09WarningsExact identifier
spl set id: 43796623-dc2a-1ab4-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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