FDA.reportPublic FDA data

Banana Boat Ultra Defense Clear Sunscreen Broad Spectrum SPF 100

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2023-11-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:50

Label at a glance#

ProductBanana Boat Ultra Defense Clear Sunscreen Broad Spectrum SPF 100
Active ingredientHOMOSALATE, OXYBENZONE, OCTOCRYLENE, 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 skin aging caused by the sun

Dosage and administration

• Hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face . Spray on hands then apply to face. • Do not apply in windy conditions • Use in well-ventilated area • 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 10.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 6.0%

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

Flammable: Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F. Do not use in the presense of a flame or spark. Keep away from sources of ignition - No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal

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 away from face to avoid breathing it • 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.

Directions

DOSAGE & ADMINISTRATION SECTION

• Hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands then apply to face. • Do not apply in windy conditions • Use in well-ventilated area • 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

Alcohol Denat., Isobutane, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Fragrance, Polyglycerly-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Ascorbyl Palmitate, Methyl Dihydroabietate, Tocopheryl Acetate, Mineral Oil, Panthenol, Water, Aloe Barbadensis Leaf Extract

Other information

SPL UNCLASSIFIED SECTION

• protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-SafeSun, Mon-Fri

Primary Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BANANA

BOAT (R)

Ultra

Defense (R)

CLEAR SUNSCREEN SPRAY

UVA/UVB BROAD SPECTRUM SPF 100

100

PROTECTS

AGAINST 99%

OF BURNING RAYS

LIGHTWEIGHT

High Endurance vs. Water

Water Resistant

(80 Minutes)

NET WT 6 OZ. (170 g)

63354-751-3463354-751-34

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-751-34Banana Boat Ultra Defense Clear Sunscreen Broad Spectrum SPF 100170 g in 1 CANSPRAY1703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-751BANANA BOAT ULTRA DEFENSE CLEAR SUNSCREEN BROAD SPECTRUM SPF 100 (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,OXYBENZONE) SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]3Current NDC, Legacy NDC, 1 package rows20231129_b00148c0-7545-104a-e053-2995a90a0bde.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
63354-75163354-751-34

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
OXYBENZONE95OOS7VE0YACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
ISOBUTANEBXR49TP611IACT
ASCORBYL PALMITATEQN83US2B0NIACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MINERAL OILT5L8T28FGPIACT
ALOE VERA LEAFZY81Z83H0XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CYCLOMETHICONE 50THT5PCI0RIACT
PANTHENOLWV9CM0O67ZIACT
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
CYCLOMETHICONE 6XHK3U310BAIACT
OCTISALATE4X49Y0596WACTIB

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 Boat Ultra Defense Clear Sunscreen Broad Spectrum SPF 100AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,OXYBENZONEEdgewell Personal Care Brands LLCb00148c0-7545-104a-e053-2995a90a0bde2023-11-28WarningsExact identifier
ndc (package): 63354-751-34
ndc (product): 63354-751
ndc11 (package): 63354075134
spl id: 0b386972-f106-f9a4-e063-6294a90a66a7
spl set id: b00148c0-7545-104a-e053-2995a90a0bde

Reported adverse events (FAERS/openFDA)#

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