FDA.reportPublic FDA data

Land Shark SPF 20

Product NDC
52854-920
11-digit product format
528540920
Labeler code
52854
Product ID
52854-920_42c9a4eb-f42b-268f-e063-6394a90afcd7
Type
HUMAN OTC DRUG
Nonproprietary name
octocrylene, octisalate, and avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Tropical Seas, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-22
Substance
OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
3; 2; 1 g/100mL; g/100mL; g/100mL
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
Land Shark SPF 20
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE3 g/100mL
OCTISALATE2 g/100mL
AVOBENZONE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b55792e6-2ead-1fb1-e053-2995a90ac915Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-920-01Land Shark SPF 20120 mL in 1 BOTTLE, PLASTICLOTION1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52854-920LAND SHARK SPF 20 (OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]5Current NDC, Legacy NDC, 1 package rows20241103_b55792e6-2ead-1fb1-e053-2995a90ac915.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 113 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenZINC OXIDEWECARE FRISCO PLLC37507b14-fc01-5e27-e063-6294a90afd502025-12-16Exact identifier
application number: M020
Non-Tinted Mineral SunscreenZINC OXIDEWECARE FRISCO PLLC375203a6-2ab8-2a80-e063-6294a90ada722025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEWECARE FRISCO PLLC3751caa3-867e-5901-e063-6294a90ab6bd2025-12-16Exact identifier
application number: M020
Auset Tinted Replenishing Daily ProtectionZINC OXIDESHAYLA BOGER SKIN THERAPY LLC37da48d6-8f12-ec97-e063-6294a90a699c2025-12-16Exact identifier
application number: M020
Morning ReplenishZINC OXIDEKATHY JONES AESTHETHICS LLC37da711e-840b-2f2a-e063-6294a90ab16c2025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEKATHY JONES AESTHETHICS LLC37dab729-5988-5eba-e063-6294a90ac6b72025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETory Sullivan, M.D., P.A.36241e60-f02a-50a7-e063-6394a90a63902025-12-16Exact identifier
application number: M020
Ageless All FitzZINC OXIDEA.Wall Beauty LLC37670cb1-ac75-5049-e063-6394a90a4d0a2025-12-16Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDETory Sullivan, M.D., P.A.36244b27-20e5-f370-e063-6294a90a1f6c2025-12-16Exact identifier
application number: M020
UV Defense Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC365e09a8-308b-b753-e063-6394a90ae9e52025-12-16Exact identifier
application number: M020
UV Defense Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDECCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC365e2498-7df2-f22c-e063-6294a90ac6ab2025-12-16Exact identifier
application number: M020
UV Protection Veil Mineral Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3bf5a6-33ec-0255-e063-6294a90ac96a2025-12-16WarningsExact identifier
application number: M020
UV Protection Veil Mineral Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3cba2e-acc6-a2df-e063-6294a90abf712025-12-16WarningsExact identifier
application number: M020
Color Smart Tinted MineralZINC OXIDEMEGAN YORK INC.365c4623-94d5-e8b6-e063-6394a90a966a2025-12-16Exact identifier
application number: M020
Anti-Aging Tinted SunscreenZINC OXIDEKARINA SALDIVAR3bca508e-7bd0-d45d-e063-6394a90a17302025-12-16WarningsExact identifier
application number: M020
UV Protection Veil Mineral Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3c757f-6581-4978-e063-6294a90a61732025-12-16WarningsExact identifier
application number: M020
Kind Restore Tinted Mineral SunscreenZINC OXIDEPOLISH BEAUTY3980810f-58b5-3a60-e063-6294a90a9c072025-12-16Exact identifier
application number: M020
Daydream Beyond ScreenZINC OXIDEULTRAVIOLET SKINCARE LLC36bfd963-d123-0d25-e063-6294a90aa8272025-12-16Exact identifier
application number: M020
Virgo SOL Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEULTRAVIOLET SKINCARE LLC369d4f43-8c57-9fcf-e063-6294a90aa9162025-12-16Exact identifier
application number: M020
Virgo SOL Non Tinted MousseTITANIUM DIOXIDE, ZINC OXIDEULTRAVIOLET SKINCARE LLC369d63a9-b9ab-9530-e063-6394a90ac8ef2025-12-16Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52854-920-0152854092001120 mL in 1 BOTTLE, PLASTIC (52854-920-01) 120 ml2020-07-220000-00-00NoNoCurrent