FDA.reportPublic FDA data

BANANA BOAT

Product NDC
63354-219
11-digit product format
633540219
Labeler code
63354
Product ID
63354-219_3c957d15-f46a-1f38-e063-6294a90af24a
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, octocrylene, oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
EdgewellPersonal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-11-19
Marketing end
2027-07-01
Substance
AVOBENZONE; OCTOCRYLENE; OXYBENZONE
Active strength
2.5; 8; 3.5 g/100g; g/100g; g/100g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BANANA BOAT

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2.5 g/100g
OCTOCRYLENE8 g/100g
OXYBENZONE3.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, 5A68WGF6WM, 95OOS7VE0Y

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-219-23BANANA BOAT118 g in 1 TUBELOTION1185

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D3BANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BABANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309BANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7BANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9BANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
HYDROGENATED POLYBUTENE (1300 MW)INACTIVE INGREDIENT7D1YQ9Y5EZBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
OCTYLDECANOLINACTIVE INGREDIENT07UG7TSU58BANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
PEG-8 DIMETHICONEINACTIVE INGREDIENTGIA7T764ODBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VBANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-219BANANA BOAT (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) LOTION [EDGEWELLPERSONAL CARE BRANDS LLC]4Current NDC, Legacy NDC, 1 package rows20231108_353353b9-54f8-4300-9632-7615de394076.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-219-2363354021923118 g in 1 TUBE (63354-219-23) 118 g2012-11-192027-07-01NoNoCurrent