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 274 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fruit of the Earth Sun Town City Mineral SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit Of The Earth, Inc.f540b0f6-3e6c-43a7-e053-2a95a90aba742024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f4481bf3-6dc7-5641-e053-2a95a90ad9382024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town CityLIP BALM SPF 30 SUNSCREEN STICKFruit of the Earth, Inc.3ec16996-ae86-4f5b-b1fd-c7b509cc5d502024-10-18WarningsExact identifier
application number: M020
Cabana Beach Club with Mentha and Essential Oils SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.f452df0c-ea8d-e25c-e053-2995a90a11432024-10-18WarningsExact identifier
application number: M020
FRUIT OF THE EARTH 100 DRY TOUCH BROAD SPECTRUM SPF 100 FACE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEFRUIT OF THE EARTH, INC.fa18f1a9-7a6a-856e-e053-6294a90aeafa2024-10-18WarningsExact identifier
application number: M020
Cabana Beach Club with Blood Orange and Essential Oils SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.f452f94a-d2f1-60ec-e053-2995a90a88272024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f45d25d2-9305-5858-e053-2a95a90a7f7b2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit Of The Earth, Inc.f53fff7a-ef8b-19c4-e053-2a95a90a4a2a2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Continuous SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEFruit Of The Earth, Inc.fd68012d-814b-ac07-e053-6394a90afc682024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Ultra SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFRUIT OF THE EARTH, INC.fd687b34-e4c6-0458-e053-6394a90ac0642024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth LUV THAT SUN Kids Sunscreen Ultra SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFRUIT OF THE EARTH, INC.fd786a06-88b7-fa35-e053-6394a90a84a52024-10-18WarningsExact identifier
application number: M020
Chemical Sunscreen SPF50 with AntipollutionHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE SUNSCREENSwiss-American CDMO, LLC59efb7dd-83f9-4222-9b7e-ea17ac4ece002024-10-18WarningsExact identifier
application number: M020
CVS Health SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyf0d6ac48-3d57-0f5c-e053-2a95a90a87cf2024-10-17WarningsExact identifier
application number: M020
CVS HEALTH SPORT SPF 50 CLEAR SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf13f7361-56b3-7ea8-e053-2995a90a76412024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 50 Ultra ProtectionAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECVS PHARMACYf11650bb-90a0-78a1-e053-2995a90a8e4c2024-10-17WarningsExact identifier
application number: M020
CVS Health Sport SPF 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacyf31dd448-dc79-21f1-e053-2a95a90a7bb62024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Breakout Free FaceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf41478c8-76c0-727f-e053-2a95a90a86692024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Ultra ProtectionAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf12ba764-afea-3f81-e053-2a95a90a12912024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf32ec4ef-352e-6a78-e053-2995a90af4912024-10-17WarningsExact identifier
application number: M020
CVS Health Sport SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf40e5664-e3ca-badf-e053-2a95a90a913e2024-10-17WarningsExact 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