FDA.reportPublic FDA data

Banana Boat

Product NDC
63354-481
11-digit product format
633540481
Labeler code
63354
Product ID
63354-481_5ee85d96-cbe3-bcee-e063-6294a90a665f
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Edgewell Personal Care Brands, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-30
Marketing end
2029-05-02
Substance
OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE
Active strength
4; 3; 9; 5 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63354-48163354-481-21DDiscontinued by firm2026-11-13

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
OCTISALATE4 g/100g
AVOBENZONE3 g/100g
HOMOSALATE9 g/100g
OCTOCRYLENE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8a1eefa6-619e-5d02-e053-2995a90a3d75Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-481-21Banana Boat29 g in 1 TUBELOTION296
63354-481-24Banana Boat177 g in 1 TUBELOTION1776
63354-481-27Banana Boat270 g in 1 TUBELOTION2706

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-481BANANA BOAT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [EDGEWELL PERSONAL CARE BRANDS, LLC]6Current NDC, Legacy NDC, 3 package rows20241127_8a1eefa6-619e-5d02-e053-2995a90a3d75.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 232 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4c639-787a-d2d3-e063-6394a90a5ded2025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4d937-77d0-273c-e063-6394a90a25e72025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4cfd9-e44c-9b93-e063-6394a90a96a62025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4e22d-6265-9c0b-e063-6394a90a15412025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4eb32-8c0b-32fc-e063-6294a90a16252025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc50182-30f2-b77e-e063-6394a90a63552025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc50182-30f5-b77e-e063-6394a90a63552025-01-15WarningsExact identifier
application number: M020
MEDIFORDEAR CICA CALMING SUNSCREENHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, AVOBENZONEYoungwon Costech Co.,ltd.2bc94923-b221-5159-e063-6394a90ab8ff2025-01-15WarningsExact identifier
application number: M020
Meaningful Beauty Cindy Crawford Anti-Aging Day Creme with Environmental Protection Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONEMeaningful Beauty, LLC6423e1c7-85cd-46f8-8fc9-a7284e3577d12025-01-15WarningsExact identifier
application number: M020
Stay AgelessTinted Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESpectrum Aesthetics Laser Training LLC026b9b30-ef08-bf2e-e063-6394a90a54a62025-01-14WarningsExact identifier
application number: M020
Daily Sunscreen Broad Spectrum SPF 30 UVA UVBMINERAL SUNSCREEN SPF 30IHerb, LLC2d8101ef-96a3-1463-e063-6294a90add4d2025-01-14WarningsExact identifier
application number: M020
ATTITUDE Sunly Tinted Mineral Sunscreen Face Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d85b0a1-3705-2829-e063-6394a90a0ed72025-01-13WarningsExact identifier
application number: M020
Attitude mineral sunscreen orange blossom SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0b85ea68-6113-4e92-a10a-39d13099d12d2025-01-13WarningsExact identifier
application number: M020
Skinfuse Shield SPF 30ZINC OXIDEOwen Biosciences, Inc.02d46d44-2476-4f96-9c72-783c392317de2025-01-13Exact identifier
application number: M020
Chem Free SPF 30ZINC OXIDEOwen Biosciences, Inc.7e5930fe-eb0f-4a21-8065-8831dd5b351c2025-01-13WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 ShellZINC OXIDEEVER FAME PTE. LTD.2b9b5a73-858e-78dd-e063-6394a90ad0822025-01-13WarningsExact identifier
application number: M020
Tula Skincare protect and go dewy glow sunscreen stick broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company2b9acb63-b32c-336c-e063-6394a90a4a9c2025-01-13WarningsExact identifier
application number: M020
Brush and Go All Skin typesTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltd9ee5b3c2-4369-4c4b-ab55-b52661b821882025-01-13WarningsExact identifier
application number: M020
Priia Tinted Mineral Sunscreen and PrimerTITANIUM DIOXIDE, ZINC OXIDEPriia Cosmetics Inc5c4219ac-d65f-43a5-8ec4-8732b9b344cf2025-01-13WarningsExact identifier
application number: M020
Brush and Go Oily Problematic SkinTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltdb4295453-f193-4bed-be5b-efcd917721072025-01-13WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-481-216335404812129 g in 1 TUBE (63354-481-21) 29 g2019-05-300000-00-00NoNoCurrent
63354-481-2463354048124177 g in 1 TUBE (63354-481-24) 177 g2019-05-302029-05-02NoNoCurrent
63354-481-2763354048127270 g in 1 TUBE (63354-481-27) 270 g2019-08-082026-12-01NoNoCurrent