FDA.reportPublic FDA data

Banana Boat Ultra Defense Clear Sunscreen Broad Spectrum SPF 100

Product NDC
63354-751
11-digit product format
633540751
Labeler code
63354
Product ID
63354-751_5ee90f18-41c3-6d57-e063-6294a90a9b10
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,OXYBENZONE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-25
Marketing end
2028-10-01
Substance
HOMOSALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE; OCTISALATE
Active strength
10; 6; 10; 3; 5 g/100g; g/100g; 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 Ultra Defense Clear Sunscreen Broad Spectrum SPF 100

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE10 g/100g
OXYBENZONE6 g/100g
OCTOCRYLENE10 g/100g
AVOBENZONE3 g/100g
OCTISALATE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
95OOS7VE0YInternal UNII lookup
5A68WGF6WMInternal UNII lookup
G63QQF2NOXInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b00148c0-7545-104a-e053-2995a90a0bdeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-751-34Banana Boat Ultra Defense Clear Sunscreen Broad Spectrum SPF 100170 g in 1 CANSPRAY1703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-751BANANA BOAT ULTRA DEFENSE CLEAR SUNSCREEN BROAD SPECTRUM SPF 100 (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,OXYBENZONE) SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]3Current NDC, Legacy NDC, 1 package rows20231129_b00148c0-7545-104a-e053-2995a90a0bde.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 325 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spit and Polish Mineral Lip Balm Broad Spectrum Lip Protectant SPF 30ZINC OXIDENaturally Uncommon, LLCaf882b7e-c64f-0de6-e053-2995a90a7ca02023-11-09WarningsExact identifier
application number: M020
EltaMD UV AOX MistZINC OXIDE SUNSCREENCP Skin Health Group, Inc1062efb1-a638-4323-88f8-f2f98a5b996e2023-11-09WarningsExact identifier
application number: M020
EltaMD UV ActiveZINC OXIDE, TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc.2c523aa0-7c34-4fc2-98a0-f2fdfe6d2cd22023-11-09WarningsExact identifier
application number: M020
Physical Sunscreen SPF50 80 min WR 159-100TITANIUM DIOXIDE, TITANIUM DIOXIDE SUNSCREENSwiss-American CDMO, LLC0cca7b65-e24a-429c-b157-5f4e343424ab2023-11-09WarningsExact identifier
application number: M020
Private Label Sunscreen SPF35 40min WR RE126-202HOMOSALATE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC254fa69f-2413-47e8-bc9b-5b7b0b59a5c82023-11-09WarningsExact identifier
application number: M020
PLANTSCRIPTION SPF 25 POWER ANTI-AGING oil FREE BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.91c14980-ba63-4705-a465-581fe11d0a982023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0NOCTISALATE, TITANIUM DIOXIDEGuerlaina20dc51a-1f6c-4a6d-97f6-2f048e0689a02023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5COCTISALATE, TITANIUM DIOXIDEGuerlaina6c8b20f-6377-443b-a89b-8b5d40c65ad82023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5NOCTISALATE, TITANIUM DIOXIDEGuerlainb6591b2e-9e55-4f25-958c-f36f1ef857492023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1.5NOCTISALATE, TITANIUM DIOXIDEGuerlain6e2ae7cb-c390-4996-95e8-ae8fadefa8bd2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1NOCTISALATE, TITANIUM DIOXIDEGuerlaina143c8cb-185c-4fd8-a901-3c0d9ffb82902023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1COCTISALATE, TITANIUM DIOXIDEGuerlain3d6e438d-9ea4-4253-9153-748d3c9742652023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2NOCTISALATE, TITANIUM DIOXIDEGuerlain173aeaab-a286-48ed-9033-10b13f547bbd2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3.5NOCTISALATE, TITANIUM DIOXIDEGuerlaind877575a-25f3-49bd-b403-ecf6a1eb483a2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 5NOCTISALATE, TITANIUM DIOXIDEGuerlain24e1e576-9edd-45aa-a883-2a2d18a1cb5e2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 6NOCTISALATE, TITANIUM DIOXIDEGuerlaina8fffe38-5f90-4078-b553-30036659a2ee2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 7NOCTISALATE, TITANIUM DIOXIDEGuerlainbfa2b2be-958c-439f-b363-2623df2b85012023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3NOCTISALATE, TITANIUM DIOXIDEGuerlain15f73322-0b27-4412-b368-84bc768f55e82023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2WOCTISALATE, TITANIUM DIOXIDEGuerlain51392fe6-fbbb-4ea9-a7aa-98e1711eaa5d2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4NOCTISALATE, TITANIUM DIOXIDEGuerlainb70b8ffc-091a-4969-86a7-6c3e1b9b9d742023-11-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-751-3463354075134170 g in 1 CAN (63354-751-34) 170 g2020-09-252028-10-01NoNoCurrent