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
OCTOCRYLENE; OXYBENZONE; AVOBENZONE
Active strength
8; 3.5; 2.5 g/100g; g/100g; g/100g
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
BANANA BOAT

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
95OOS7VE0YInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
353353b9-54f8-4300-9632-7615de394076Available on FDA.report

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

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 25 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.52ba9423-8b9b-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
application number: M020
Odacite Color Balm - Frosted PetalZINC OXIDEOdacite52ba9423-8b9d-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - DawnZINC OXIDEIris and Romeo52bb700b-ff56-2286-e063-6394a90ac4582026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - CamelliaZINC OXIDEIris and Romeo52bb52ec-2cd7-f8cc-e063-6294a90aa61b2026-05-26WarningsExact identifier
application number: M020
Bubble Solar Mate Daily Mineral Sunscreen SPF 40ZINC OXIDEBubble Beauty, Inc.d2eca90f-9463-4d2f-975d-02f2802ded3e2026-05-26WarningsExact identifier
application number: M020
Plexus Sun Shield Hydrating Mineral Sunscreen SPF 30ZINC OXIDEPlexus Worldwide, LLC55c391fa-37c6-47a2-befd-12888eb5fc182026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - SuedeZINC OXIDEIris and Romeo52bb7505-a027-2533-e063-6294a90a25202026-05-26WarningsExact identifier
application number: M020
Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc9c909ae0-0117-4675-afc2-533d542f36592026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - CarobZINC OXIDEIris and Romeo52bbe9da-37f8-b3ba-e063-6394a90a139e2026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - CameoZINC OXIDEIris and Romeo52bc0174-872d-445b-e063-6294a90ab3292026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - IconicZINC OXIDEIris and Romeo52bbfdfe-dfc9-364f-e063-6294a90a646d2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulip Dew BronzeZINC OXIDEBloomeffects52bc7f23-3594-3173-e063-6294a90a81ea2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulip DewZINC OXIDEBloomeffects0fcb1b45-c04d-310a-e063-6294a90ab56d2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Mauve MomentZINC OXIDEBloomeffects52bd7522-81b5-6189-e063-6394a90a29b42026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil BarelyZINC OXIDEBloomeffects52bd8a43-a8c2-897e-e063-6394a90a9f3d2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Fruit PunchZINC OXIDEBloomeffects52bdc0ec-ac5e-4a57-e063-6294a90a0b3b2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Tulipy PinkZINC OXIDEBloomeffects52bdc5cc-9742-4af6-e063-6294a90aba222026-05-26WarningsExact identifier
application number: M020
Alleyoop Sun Serum Lip Oil - DaylightZINC OXIDENewAlley Innovations Inc52be1071-67cb-f2c0-e063-6294a90a368c2026-05-26WarningsExact identifier
application number: M020
Alleyoop Sun Serum Lip Oil - HazyZINC OXIDENewAlley Innovations Inc52be3c9e-a791-5053-e063-6294a90a1b302026-05-26WarningsExact identifier
application number: M020
Alleyoop Sun Serum Lip Oil - WhirlwindZINC OXIDENewAlley Innovations Inc52be633a-fc64-7456-e063-6294a90a8fc02026-05-26WarningsExact identifier
application number: M020

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