FDA.reportPublic FDA data

Banana Boat

Product NDC
63354-911
11-digit product format
633540911
Labeler code
63354
Product ID
63354-911_3c956712-5a7e-0526-e063-6294a90ac603
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE OCTOCRYLENE OXYBENZONE
Dosage form
LOTION
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-02-19
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

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
AVOBENZONE2.5 g/100g
OCTOCRYLENE8 g/100g
OXYBENZONE3.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0f772b91-e67b-46cf-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-911-53Banana Boat118 g in 1 BOTTLELOTION1187

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
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBANANA 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 METHYL ABIETATEINACTIVE INGREDIENTA23O709X8OBANANA 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
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DRBANANA BOAT (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBANANA 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
63354-911BANANA BOAT (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]6Current NDC, Legacy NDC, 1 package rows20231110_0f772b91-e67b-46cf-e054-00144ff8d46c.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 47 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena Ultra Gentle Daily Facial Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef669b9-df00-8965-e063-6394a90ab3352026-04-08WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef6a60a-6634-e79b-e063-6394a90a3daa2026-04-08WarningsExact identifier
application number: M020
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef6b5fb-5495-001c-e063-6394a90ab7b32026-04-08WarningsExact identifier
application number: M020
Sunright Lip BalmOCTINOXATE, AVOBENZONE, AND OCTOCRYLENENSE Products, Inc.dfdb2d0a-c646-4c44-b648-e2fdd604cdc92026-04-08WarningsExact identifier
application number: M020
Nu Colour Bioadaptive BB Plus Foundation - Light GoldenTITANIUM DIOXIDENSE Products, Inc.faae6f47-19f3-41cb-8e0d-388569b5c73d2026-04-07WarningsExact identifier
application number: M020
Ultra SunscreenOCTINOXATE, OCTISALATE, TITANIUM DIOXIDEJiangsu Senwo Medical Technology Co., Ltd.4ed974b8-6c11-08e0-e063-6294a90a77132026-04-07WarningsExact identifier
application number: M020
Vivaiodays SPF 30 Sunscreen with TurmericSPF 30 SUNSCREEN WITH TURMERIC5SENCO INC4ee0c93a-7f50-2bda-e063-6294a90abff42026-04-07WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE MEDIUM DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc4ee39bbf-b7d7-8f87-e063-6294a90a25392026-04-07WarningsExact identifier
application number: M020
BEVERLY HILLS MD SHEER RADIANCE SPF DROPS SUNSCREENZINC OXIDEBeverly Hills MD, LLC4ed34743-cc68-501b-e063-6294a90ad3962026-04-07WarningsExact identifier
application number: M020
Nu Colour Bioadaptive BB plus Foundation - BeigeTITANIUM DIOXIDENSE Products, Inc.f74e83fe-41a0-4998-ae53-30ed5af475922026-04-07WarningsExact identifier
application number: M020
Thinksport SPF 30ZINC OXIDEthinkOperations,LLC33065919-9b4e-4b2b-9306-a706558241c82026-04-07WarningsExact identifier
application number: M020
Nutricentials Day Dream ProtectiveHOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENENSE Products, Incdaca8347-f7e7-4733-bd22-1da7a6076fad2026-04-06WarningsExact identifier
application number: M020
TONEfitSUN Ultra Moisturizing Vegan SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory4ec58c23-16b1-03bb-e063-6394a90a46c02026-04-06WarningsExact identifier
application number: M020
Dior Forever Velvet Veil 24H Mattifying Makeup Base Blurring-Smoothing Pore Refining Effect with Sunscreen SPF 15HOMOSALATE, OCTISALATE, OCTOCRYLENEParfums Christian Diorbe36b83f-662d-49c6-a12f-a64e11721d0c2026-04-06WarningsExact identifier
application number: M020
Pure SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELiz Corporation Ltd4eca5257-6840-2a33-e063-6394a90ade282026-04-06WarningsExact identifier
application number: M020
Dior Forever Skin Veil 24H Glow Hydrating Base Plumping and Smoothing Effect Hyaluronic Acid with Sunscreen SPF 25ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENEParfums Christian Dior4a5147f3-4e52-447a-a89c-058aea8a612c2026-04-06WarningsExact identifier
application number: M020
Simple Mineral Sunscreen SPF 50ZINC OXIDESimple Sunscreen LLCc38cb4fa-8b8d-4c2d-9c32-301e120db1a12026-04-06WarningsExact identifier
application number: M020
Badger SPF 50 Adventure Sport Mineral Sunscreen CreamZINC OXIDEW.S. Badger Company, Inc.2a96c423-f4ad-0f07-e063-6394a90a39f82026-04-06WarningsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 55AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC03fce792-bcbb-4848-bc87-8913ecbe07862026-04-06Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC8937705d-b745-4b8c-bf9b-89e64a1e52b12026-04-06Warnings, Adverse reactionsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-911-5363354091153118 g in 1 BOTTLE (63354-911-53) 118 g2015-02-192027-07-01NoNoCurrent