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_0b386972-f106-f9a4-e063-6294a90a66a7
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
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
Listing certified through
2026-12-31
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
Listing expiration
2026-12-31

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 223 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD0ce809a1-45fb-9d4d-e063-6294a90a26a22025-03-23WarningsExact identifier
application number: M020
GLOW BODY MIST SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTDcba78484-3c0b-413e-e053-2995a90aad862025-03-23WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID NATURAL SUNCREAMZINC OXIDEISNTREE Inc.2a86be75-c0f3-a8a1-e063-6294a90a04482025-03-23WarningsExact identifier
application number: M020
SPF50 SHEER GLOW BALM ESPRESSO MARTINI 9gZINC OXIDE 22.75%NAKED SUNDAY PTY LTDfbfc1e74-139e-8b0d-e053-6394a90a97c52025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment Caramel Latte 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD2499e14a-c14f-ea13-e063-6394a90a62f52025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD24a7bee2-3802-4786-e063-6294a90a6ab52025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment VANILLA CONFETTI 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD24aa19c8-86d9-c691-e063-6394a90a691e2025-03-22WarningsExact identifier
application number: M020
Naked Sundays PoutScreen Plumping Lip Treatment Marshmallow 10mLLIP TREATMENTNAKED SUNDAYS PTY LTD24a98d3d-f830-9614-e063-6394a90aa7d12025-03-22WarningsExact identifier
application number: M020
SPF50 SHEER GLOW BALM CHAMPAGNE 9gZINC OXIDE 22.75%NAKED SUNDAY PTY LTDfbfb871b-460f-271a-e053-6394a90acad22025-03-22WarningsExact identifier
application number: M020
Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Bronze 8gZINC OXIDENAKED SUNDAYS PTY LTD2f42d22a-983e-d304-e063-6294a90a37192025-03-22WarningsExact identifier
application number: M020
SPF50 SHEER GLOW BALM ROSE 9gZINC OXIDE 22.75%NAKED SUNDAY PTY LTDfbfbd0dd-8961-5fd0-e053-6294a90a5de42025-03-22WarningsExact identifier
application number: M020
Naked Sundays Face Body Clear Glow Sunstick SPF50 SHIMMER Broad Spectrum SPF50 19gAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5% ,OCTOCRYLENE 8%NAKED SUNDAYS PTY LTD2f47a6c9-dd0a-da94-e063-6294a90a9a452025-03-22WarningsExact identifier
application number: M020
Obagi Skintrinsiq Firming ProtocolTITANIUM DIOXIDE AND ZINC OXIDEObagi Cosmeceuticals LLC67ba9f32-bbf4-4c14-9e97-08f1cb7d39962025-03-21WarningsExact identifier
application number: M020
Obagi Skintrinsiq Brightening ProtocolHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLC2f75ebf7-d6b6-45c6-ad5b-61739d260ff72025-03-21WarningsExact identifier
application number: M020
Hello Kitty Fun Broad Spectrum SPF 40ZINC OXIDEThe Creme Shop Inc30d37581-122c-ec92-e063-6294a90ab4252025-03-21WarningsExact identifier
application number: M020
Hello Kitty Sunny Days Broad Spectrum SPF 40ZINC OXIDEThe Creme Shop Inc30d3ed8c-f424-8d95-e063-6394a90a0cbc2025-03-21WarningsExact identifier
application number: M020
Carmex Variety Pack Daily Care Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.c7142781-fa57-43e5-9436-cb29dd03a6692025-03-21WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTORAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION00ec7d9c-8550-45ce-8d0a-ef2caf84f98d2025-03-21WarningsExact identifier
application number: M020
Obagi Skintrinsiq Clarifiying ProtocolSALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDEObagi Cosmeceuticals LLC08ba9ea8-73fd-472b-9cc4-67df167352ec2025-03-21WarningsExact identifier
application number: M020
Aveeno Kids Continuous Protection Sensitive Skin Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC3e51da46-6a81-4b74-b16e-3fc298a4ba592025-03-20WarningsExact 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 g2020-09-250000-00-00NoNoCurrent