FDA.reportPublic FDA data

Banana Boat Sport Mineral SPF 50

Product NDC
63354-043
11-digit product format
633540043
Labeler code
63354
Product ID
63354-043_2581ecb4-d81b-1222-e063-6394a90a6686
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
2022-04-12
Marketing end
2026-12-01
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
6.5; 4.5 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 packagepackage63354-04363354-043-24DDiscontinued by firm2026-10-20

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 · 9 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…

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 Sport Mineral SPF 50

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE6.5 g/100g
TITANIUM DIOXIDE4.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dc79790f-e2bc-5414-e053-2a95a90a9e7aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-043-24Banana Boat Sport Mineral SPF 50177 g in 1 TUBELOTION1773
63354-043-27Banana Boat Sport Mineral SPF 50266 g in 1 TUBELOTION2663

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-043BANANA BOAT SPORT MINERAL SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]3Current NDC, Legacy NDC, 2 package rows20241029_dc79790f-e2bc-5414-e053-2a95a90a9e7a.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 83 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunscreen Lotion118mLZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46355437-4068-9d03-e063-6394a90ae52c2026-01-09WarningsExact identifier
application number: M020
ST MORIZ SUNCARE FACE SUNSCREEN SPF30SUNCARE FACE SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.47f26af6-4d02-3506-e063-6294a90a0fe62026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sun 6 SPF Tan and Care CarrotOCTINOXATEFarmasi US LLC67de9257-70f3-4444-a4a2-a8d7425fcc0e2026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sunscreen SPF30 Broad SpectrumAVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATEFarmasi US LLCd9197dce-20a3-4d10-807c-ec84ab9021652026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Lumi Radiance BrighteningOCTOCRYLENE, OCTINOXATE, AVOBENZONEFarmasi US LLCadf5621b-7cf0-53b3-e053-2a95a90a80582026-01-09WarningsExact identifier
application number: M020
Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15HOMOSALATE, OCTINOXATEFARMASI US LLC1dbd5e83-2248-4751-88d9-b446ccc3c61e2026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sunscreen 50 SPF UVA UVB Protection Face and Body SunAVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATEFarmasi US LLC27fdbd2b-60de-4906-a176-5c5198d9925b2026-01-09WarningsExact identifier
application number: M020
Skin Metal StealthZINC OXIDESkin Metal47f5d7de-5d32-041a-e063-6394a90ab6f92026-01-09WarningsExact identifier
application number: M020
Salt and Blue Body Sunscreen SPF 30ZINC OXIDE 20%Salt + Blue LLC47f764a0-e9ad-ef66-e063-6394a90a8de52026-01-09WarningsExact identifier
application number: M020
City Sunscreen serum Broad Spectrum SPF 30 SupergoopHOMOSALATE, OCTISALATE, AVOBENZENE, OCTOCRYLENESupergoop, LLC61766f7b-512d-45b5-b652-e09975a3d3fc2026-01-09WarningsExact identifier
application number: M020
Defense Refresh (Re)Setting Mist SPF 40AVOBENZONE, HOMOSALATE , OCTISALATE, OCTOCRYLENESupergoop LLCb95ad8e3-978b-b721-e053-2a95a90a1e542026-01-09WarningsExact identifier
application number: M020
Daily Dose Vitamin C and Broad Spectrum SPF 40 SerumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop LLCaed0dd03-1695-a5a9-e053-2995a90acfdc2026-01-09WarningsExact identifier
application number: M020
Hand Screen Broad Spectrum Sunscreen SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENESupergoop, LLC972ebab9-3f2f-6716-e053-2a95a90a5c752026-01-09WarningsExact identifier
application number: M020
Glow Oil Broad Spectrum Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC972c68e7-b137-34c6-e053-2a95a90a77d62026-01-09WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Coconut SPF 15 Scented Lip GlossHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCee045b64-7a95-4378-8183-e6e556f3b1842026-01-09WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Papaya SPF 15 Scented Lip GlossHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC967d0657-18fc-4e4a-b52d-442df43329f12026-01-09WarningsExact identifier
application number: M020
PLAY SPF 30 Lip Shield CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCb0b8b850-bdfe-5563-e053-2995a90a51a72026-01-09WarningsExact identifier
application number: M020
Play SPF 30 Lip Shield StrawberryAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCb0a49142-53c3-5b7a-e053-2995a90a581d2026-01-09WarningsExact identifier
application number: M020
Glow Stick Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENESupergoop, LLC61e543e3-9ace-6440-e053-2991aa0a96472026-01-09WarningsExact identifier
application number: M020
(RE) Setting 100% Mineral Powder Translucent Broad Spectrum Sunscreen SPF 35ZINC OXIDESupergoop, LLCaf5c9801-26ce-5c60-e053-2995a90ab4572026-01-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-043-2463354004324177 g in 1 TUBE (63354-043-24) 177 g2022-04-120000-00-00NoNoCurrent
63354-043-2763354004327266 g in 1 TUBE (63354-043-27) 266 g2022-04-122026-12-01NoNoCurrent