FDA.reportPublic FDA data

Banana Boat Ultra Defense Broad Spectrum

Manufacturer
KIK Custom Products
Effective date
2010-03-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:23:59

Label at a glance#

ProductBanana Boat Ultra Defense Broad Spectrum
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Label structure5 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts:

Avobenzone:     1.5%
Homosalate:       15%
Octisalate:            5%
Octicrylene:        1.25%
Oxybenzone:    6%

Purpose:  Sunscreen

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT, DO NOT GET INTO EYES IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.
STOP USE AND ASK DOCTOR IS IRRITATION OR RASH DEVELOPS.  KEEP OUT OF REACH OF CHILDREN.
IF SWALLOWED, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER RIGHT AWAY.

INACTIVE INGREDIENT SECTION

Water, Cetearyl Alcohol, Glycerin, Capryly Glycol, Hydrogenated Dimer Dilnoleyl/Dimethyl Carbonate,
Copolymer, Cetyl Alcohol, Triethanolamine, Behenyl Acohol, Glyceryl Stearate, Glyceryl Stearate, Citrate,
Disodium Ethylene, Dicocamide PEG-15 Disulfate, Sodium Lauroyl Sarcosinate, Carbomer, Xanthan Gum,
Aloe Barbadensis Leaf Juice, Retinyl Palmitate (Vitamin A), Tocopherol, Tocopheryl Acetate (Vitamin E),
Cetearyl Alchol, Sodium Lauroyl, Lactylate, Lecithin, BHT, Methyl Dibromo Glutaronitrile, Methyl Chloisothiazolinone.
Methyl Isothiazolinone, Phenoxy Ethanol, Dipropylene Glycol, Disodium EDTA

OTC - QUESTIONS SECTION

Questions or Comments:  Call 1-800-SAFESUN Mon-Fri.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of Tube Label - Back
Image of Tube Label - Back

Image of Tube Label - Front
Image of Tube Label - Front

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61047-811-722020-01-31C16284748780-19d75b9cf-d3d3-f424-e053-dadaa90a57ceBanana Boat Sport Performance Active Dry Protect SPF 50 - Long Lasting Protection, Sun Tested, Sun Proven

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61047-811-72Banana Boat Ultra Defense Broad Spectrum236 mL in 1 TUBELOTION2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61047-811BANANA BOAT ULTRA DEFENSE BROAD SPECTRUM (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [KIK CUSTOM PRODUCTS]1Legacy NDC, 1 package rows20100327_4cafdf1c-97cd-4326-9ac6-b3b89bcea2bc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
HomosalateACTIVE INGREDIENTV06SV4M95S1
OctisalateACTIVE INGREDIENT4X49Y0596W1
OctocryleneACTIVE INGREDIENT5A68WGF6WM1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
HomosalateACTIVE MOIETYV06SV4M95S1
OctisalateACTIVE MOIETY4X49Y0596W1
OctocryleneACTIVE MOIETY5A68WGF6WM1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61047-81161047-811-72

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
Oxybenzone95OOS7VE0YACTIB

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
98665009-5a5a-459d-8c42-47b44ffbe2054cafdf1c-97cd-4326-9ac6-b3b89bcea2bc2010-03-23WarningsExact identifier
spl id: 98665009-5a5a-459d-8c42-47b44ffbe205
spl set id: 4cafdf1c-97cd-4326-9ac6-b3b89bcea2bc

Reported adverse events (FAERS/openFDA)#

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