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 19 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Sunscreen SPF 50MINERAL SUNSCREENALAINA HEALTHCARE PRIVATE LIMITED7e036f9f-b26d-4f11-911c-c1fa854edb0f2026-06-17WarningsExact identifier
application number: M020
Not there spf broad spectrum spf40 moisturizerAVOBENZONE 3% ,HOMOSALATE 10% ,OCTISALATE 5% ,OCTOCRYLENE 8% ,ZINC OXIDE 4%Foshan Sugar Max Cosmetics CO.,Ltd546f0474-4102-26d0-e063-6394a90a388b2026-06-17WarningsExact identifier
application number: M020
Ultra Violette Velvet Screen Blurring Mineral Skinscreen Broad Spectrum SPF 40ZINC OXIDEGrace and Fire USA Inc.52d4b1c1-7431-4f8c-e063-6294a90ad4822026-06-17WarningsExact identifier
application number: M020
EVIL GOODS TALLOW SUNSCREEN SPF30ZINC OXIDEMoes Group LLC54751f23-5723-0407-e063-6294a90a4a962026-06-17WarningsExact identifier
application number: M020
Amber Sunglaze Sheer Body Mist Sunscreen SPF30AVOBENZONE, OCTISALATE, OCTOCRYLENEKoco Life LLC5478fb36-e972-f824-e063-6294a90a567f2026-06-17WarningsExact identifier
application number: M020
Elaine Sterling Hydrating SunscreenZINC OXIDEElaine Sterling Enterprises5479e862-aca5-7541-e063-6394a90ad0c52026-06-17WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS545aa56a-ed07-acd6-e063-6394a90ae0c72026-06-16WarningsExact identifier
application number: M020
MAYBELLINE NEW YORK FIT ME DEWY PLUS SMOOTH FOUNDATION SPF 18 SUNSCREENOCTISALATELOreal USA Products Inc3b99ab06-ba4c-4ddd-a057-60028eedd67d2026-06-16WarningsExact identifier
application number: M020
TERRA LOTUS SPF 50 ORGANIC TALLOW SUNSCREENZINCOXIDEMoes Group LLC54617bf2-1d8d-531e-e063-6294a90a70802026-06-16WarningsExact identifier
application number: M020
Daily Defence Mineral Sunscreen SPF 50 Fragrance FreeZINC OXIDEUltraceuticals Pty Ltd5461ee82-0297-ce22-e063-6294a90a729b2026-06-16WarningsExact identifier
application number: M020
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
application number: M020
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
application number: M020
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
application number: M020
TITAN TALLOW SPF 50 ORGANIC TALLOW SUNSCREENZINC OXIDEMoes Group LLC546b0702-a3cc-fd6f-e063-6394a90af8492026-06-16WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET MINERAL SPF 30ZINC OXIDEWhole Foods Market, Inc.5ce712d6-cafd-4a80-9f8c-2149fdebff542026-06-16WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET MINERAL SPF 50ZINC OXIDEWhole Foods Market, Inc.1f8387be-d871-435b-baef-e537c67a510a2026-06-15WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 50OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND HOMOSALATEWhole Foods Market, Inc.82771f22-0197-40ba-97d2-2386152790ed2026-06-15WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWhole Foods Market, Inc.1c31f466-6a0d-46ce-9346-d2a0eb46c8d02026-06-15WarningsExact identifier
application number: M020
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
application number: M020
Solvyn Mineral Sunscreen SPF 50ZINC OXIDESolvyn Skin LLCb0a8d028-87d2-4339-8879-c62cbf8415f22026-06-15WarningsExact 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