FDA.reportPublic FDA data

Banana Boat Ultra Defense SPF 85

Manufacturer
Accra-Pac, Inc.
Effective date
2010-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:24:01

Label at a glance#

ProductBanana Boat Ultra Defense SPF 85
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE
Label structure10 sections

Dosage and administration

apply generously and evenly to all areas 15 minutes before sun exposure spray on hands to apply to face use in well-ventilated area reapply at frequent intervals and after swimming or towel drying ask a doctor before use on children under six months of age

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 0.03mL / 1mL

Homosalate 0.15mL / 1mL

Octocrylene 0.10mL / 1mL

Oxybenzone 0.06mL / 1mL

Purpose

DESCRIPTION SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

helps prevent sunburn

Warnings

WARNINGS SECTION

  • For external use only
  • Do not spray directly into face
  • Flammable: do not use near heat, flame, or while smoking

When using this product

OTC - WHEN USING SECTION

  • avoid spraying in eyes. If contact occurs, rinse thoroughly with water.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or rash develops

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply generously and evenly to all areas 15 minutes before sun exposure
  • spray on hands to apply to face
  • use in well-ventilated area
  • reapply at frequent intervals and after swimming or towel drying
  • ask a doctor before use on children under six months of age

Other Information

SPL UNCLASSIFIED SECTION

Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

  • May stain some fabrics.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

SD Alcohol 40-B, Cyclopentasiloxane, Cyclohexasiloxane, C12-C15 Alkyl Lactate, Trimethylolpropane Tricaprylate/Tricaprate, Dicaprylyl Carbonate, Acrylates/Octylacrylamide Copolymer, Caprylyl Glycol, Dimethyl Capramide, Aloe Barbadensis Leaf Extract, Retinyl Palmitate (Vitamin A), Tocopherol, Fragrance.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800 SafeSun, Mon-Fri

Dist. by:
SUN PHARMACEUTICALS, LLC
SHELTON, CT 06484

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLEAR
UltraMist®
BANANA
BOAT®
Ultra
DefenseTM
Sheer Protect
Continuous Spray Sunscreen
SPF/UVB 85
with Aloe Vera
AvoTriplexTM
High UVA
Long-Lasting Protection
Sun-Tested, Sun-ProvenTM
Lightweight & Rub-Free
Skin Cancer Foundation Recommended
Very Water Resistant
6 FL. OZ. (177mL)

PRINCIPAL DISPLAY PANEL Banana Boat Ultra Defense SPF 85PRINCIPAL DISPLAY PANEL Banana Boat Ultra Defense SPF 85

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17630-2015-12020-01-31C16284748780-19d75b9d0-a1e3-f424-e053-dadaa90a57ceBanana Boat Ultra Defense SPF 85
17630-2015-22020-01-31C16284748780-19d75b9d0-a1e3-f424-e053-dadaa90a57ceBanana Boat Ultra Defense SPF 85

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17630-2015-1Banana Boat Ultra Defense SPF 85177 mL in 1 CANSPRAY1771
17630-2015-2Banana Boat Ultra Defense SPF 85236 mL in 1 CANSPRAY2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17630-2015BANANA BOAT ULTRA DEFENSE SPF 85 (AVOBENZONE AND HOMOSALATE AND OCTOCRYLENE AND OXYBENZONE) SPRAY [ACCRA-PAC, INC.]1Legacy NDC, 2 package rows20100330_0d208fbd-ceef-4e9d-a54f-38f8b640113f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BA1
DICAPRYLYL CARBONATEINACTIVE INGREDIENT609A3V1SUA1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17630-201517630-2015-1, 17630-2015-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 6XHK3U310BAIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALOE VERA LEAFZY81Z83H0XIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates

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
901b758c-9233-4d40-ac15-64487d1ceaca0d208fbd-ceef-4e9d-a54f-38f8b640113f2010-03-25WarningsExact identifier
spl id: 901b758c-9233-4d40-ac15-64487d1ceaca
spl set id: 0d208fbd-ceef-4e9d-a54f-38f8b640113f

Reported adverse events (FAERS/openFDA)#

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