FDA.reportPublic FDA data

Banana Boat

Product NDC
63354-755
11-digit product format
633540755
Labeler code
63354
Product ID
63354-755_2529b8fc-9cc0-acfb-e063-6394a90a5f16
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Edgewell Personal Care Brands, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-02
Marketing end
2026-12-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
4.5; 6.5 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 packagepackage63354-75563354-755-21DDiscontinued by firm2026-10-23

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 · 10 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…

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
TITANIUM DIOXIDE4.5 g/100g
ZINC OXIDE6.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
441a46f0-ecda-4448-e054-00144ff88e88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-755-21Banana Boat29 g in 1 TUBELOTION299
63354-755-27Banana Boat270 g in 1 TUBELOTION2709
63354-755-54Banana Boat177 g in 1 BOTTLELOTION1779

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-755BANANA BOAT (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE BRANDS, LLC]9Current NDC, Legacy NDC, 3 package rows20241025_441a46f0-ecda-4448-e054-00144ff88e88.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 91 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bellas Friends Roll-on SunscreenTITANIUM DIOXIDE, ZINC OXIDEPANERGYTEK USA INC478d46ce-14e8-2231-e063-6394a90a3e272026-01-04WarningsExact identifier
application number: M020
Ava Isa Sun Lip Sun Whip Clear SunshineZINC OXIDECyberderm Laboratories inc.a8646ee4-5e6e-6cdd-e053-2a95a90aee772026-01-01WarningsExact identifier
application number: M020
Ava Isa Sun Lip Sun Whip Strawberry ZinniaZINC OXIDECyberderm Laboratories inc.a888396f-489f-7e7c-e053-2995a90aee5b2026-01-01WarningsExact identifier
application number: M020
Ava Isa Sun Lip Sun Whip Watermelon LilyZINC OXIDECyberderm Laboratories inc.a8889754-8e33-4d2a-e053-2995a90a60802026-01-01WarningsExact identifier
application number: M020
OKeeffes Lip RepairAVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENEThe Gorilla Glue Company/O'Keeffe's Company6805b3e9-77cb-bfee-e053-2991aa0a8d982026-01-01WarningsExact identifier
application number: M020
Walgreens 50 Pina Colada Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY4978c811-be34-9fc3-e063-6394a90a2d802026-01-01WarningsExact identifier
application number: M020
Unicorn Snot 35 SPF Glitter Spritz rose gold shimmerAVOBENZONE, OCTISALATE, OCTOCRYLENEJailbreak Toys, Inc. DBA UNICORN SNOT498b7c1a-e66d-9736-e063-6394a90a47122026-01-01WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Day Cream SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBCM Ltdf7d5aa8a-9f4a-426b-ac9d-9690cf0103e02026-01-01WarningsExact identifier
application number: M020
MAUI ISLAND SECRET BROWNING CREME Broad Spectrum Sunscreen SPF 5ZINC OXIDEFormula 7venz L.L.C.5f3cdec9-2cc2-4660-827f-d286883d907c2025-12-31WarningsExact identifier
application number: M020
SOLARA SUNCARE - GO VACATION GLOW SPF 30ZINC OXIDESOLARA SUNCARE, INC.1f5cb694-f065-7ebc-e063-6394a90a883a2025-12-31WarningsExact identifier
application number: M020
SUNSCREEN GLOWING, SPF 30SUNSCREEN GLOWING LOTIONFSA Store Inc473bcb90-ab7f-170b-e063-6294a90a99d52025-12-31WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC05ba5966-f0ff-5360-e063-6294a90a0fc92025-12-31WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC08f4599b-de62-2bc7-e063-6394a90a69ab2025-12-31WarningsExact identifier
application number: M020
Hawaiian Tropic Everyday Active SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc8e2ee8-e67f-ef5d-e053-2995a90a15202025-12-31WarningsExact identifier
application number: M020
Sunscreen Glowing, SPF 30SUNSCREEN GLOWING LOTIONCardinal Health, Inc28ed3b60-1139-f657-e063-6394a90a52fa2025-12-31WarningsExact identifier
application number: M020
Sunscreen Setting Spritz, SPF 45SUNSCREEN SETTING SPRAYCardinal Health, inc.293e9656-8644-b9aa-e063-6294a90a5b272025-12-31WarningsExact identifier
application number: M020
Sunscreen Setting Spritz, SPF 45SUNSCREEN SETTING SPRAYFSA Store Inc473d6804-8d20-6899-e063-6294a90a31312025-12-31WarningsExact identifier
application number: M020
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47428cd4-fbad-ba7a-e063-6394a90a1c5c2025-12-31WarningsExact identifier
application number: M020
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47433a62-91e0-b031-e063-6294a90a0d492025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4743b6a9-4d79-1b2b-e063-6394a90a97102025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-755-016335407550111 g in 1 PACKET (63354-755-01) 11 g2017-01-020000-00-00NoNoCurrent
63354-755-216335407552129 g in 1 TUBE (63354-755-21) 29 g2017-01-020000-00-00NoNoCurrent
63354-755-2763354075527270 g in 1 TUBE (63354-755-27) 270 g2017-01-022026-12-01NoNoCurrent
63354-755-5463354075554177 g in 1 BOTTLE (63354-755-54) 177 g2017-01-022026-12-01NoNoCurrent
63354-755-5663354075556221 g in 1 BOTTLE (63354-755-56) 221 g2017-01-020000-00-00NoNoCurrent