FDA.reportPublic FDA data

Banana Boat

Product NDC
63354-481
11-digit product format
633540481
Labeler code
63354
Product ID
63354-481_27c51ad3-5f8e-032d-e063-6394a90a4860
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
Substance
OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE
Active strength
4; 3; 9; 5 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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 firm2026-10-15

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
Listing expiration
2026-12-31

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 37 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF Lip ColourZINC OXIDELauren Brooke Cosmetiques, LLC50b344b5-e39d-48ef-e063-6394a90ae41c2026-04-30WarningsExact identifier
application number: M020
No 7 Prime Forever SPF 50 PrimerNO 7 PRIME FOREVER BROAD SPECTRUM SUNSCREEN SPF50 PRIMERBoots Retail USA50b3e9fa-faf8-0026-e063-6294a90a08232026-04-30WarningsExact identifier
application number: M020
Tru Skin Rituals SPF 25TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilf725cd5c-999e-2393-e053-6394a90a09dc2026-04-30WarningsExact identifier
application number: M020
Moisture Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilcb95975f-060d-23c2-e053-2a95a90adf1b2026-04-30WarningsExact identifier
application number: M020
Day Cream SPF 30OCTOCRYLENE, OCTINOXATE, AVOBENZONEAnthony Skin LLC5070e8cc-12c0-c2c4-e063-6294a90a14222026-04-29WarningsExact identifier
application number: M020
Steak n Shake Beef Tallow Sunscreen SPF 30ZINC OXIDEHRR Enterprises, Inc0eb122d8-6826-4843-bed1-9e0cb8316e6d2026-04-29WarningsExact identifier
application number: M020
EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWalmart509b6c7d-8a28-2d3a-e063-6394a90af0682026-04-29WarningsExact identifier
application number: M020
Freaks of Nature Solar Shield Broad Spectrum SPF 30FREAKS OF NATURE SOLAR SHIELD BROAD SPECTRUM SPF 30THE FREAKS OF NATURE, INC.509b8610-6dbe-611f-e063-6394a90a9fd12026-04-29WarningsExact identifier
application number: M020
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
application number: M020
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
application number: M020
COTZ FACE MOISTUREZINC OXIDEFallien Cosmeceuticals Ltd.509d9a74-bc8d-c9c1-e063-6394a90a403d2026-04-29WarningsExact identifier
application number: M020
JMSOLUTION MARINE LUMINOUS PEARL SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGPNY CORP212d4563-2fad-31a5-e063-6394a90aff712026-04-29WarningsExact identifier
application number: M020
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Glow Daily Glow Sunscreen Bronze Cell OX Shield Broad Spectrum SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc5e19577b-9911-4fa1-a2b7-7ca2e02d1fd82026-04-28WarningsExact identifier
application number: M020
Daily Defence Moisturising Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEUltraceuticals Pty Ltd50888d3f-46ae-e2c2-e063-6394a90ad6af2026-04-28WarningsExact identifier
application number: M020
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
application number: M020
Fusion Water MagicOCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONEISDIN Corp.d4f91d5a-600a-4255-a6e1-e7e7197848c72026-04-28WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Glow Daily Glow Sunscreen Pearl Cell OX Shield Broad Spectrum SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc6a1b995-1898-4a92-b128-7d5ebd6d8d3d2026-04-28WarningsExact identifier
application number: M020
Obagi Skintrinsiq Antioxidant ProtocolAVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENE, AND OXYBENZONEObagi Cosmeceuticals LLC53023b16-8d64-4dfc-bc75-b4f248425c4d2026-04-27WarningsExact identifier
application number: M020
TONEfitSUN Sebum Control Vegan SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory506b96ae-eb2a-edad-e063-6294a90a470e2026-04-27WarningsExact 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 g2019-05-300000-00-00NoNoCurrent
63354-481-2763354048127270 g in 1 TUBE (63354-481-27) 270 g2019-08-082026-12-01NoNoCurrent