FDA.reportPublic FDA data

Land Shark SPF 50

Product NDC
52854-950
11-digit product format
528540950
Labeler code
52854
Product ID
52854-950_42c997c2-5c4a-56ff-e063-6294a90a15e5
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
2020-02-14
Substance
OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
10; 5; 3 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 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE10 g/100mL
OCTISALATE5 g/100mL
AVOBENZONE3 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
b4cc95f0-d684-5331-e053-2995a90a3295Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-950-01Land Shark SPF 5060 mL in 1 BOTTLE, PLASTICLOTION606
52854-950-02Land Shark SPF 50120 mL in 1 BOTTLE, PLASTICLOTION1206
52854-950-03Land Shark SPF 50192 mL in 1 BOTTLE, PLASTICLOTION1926
52854-950-04Land Shark SPF 50946 mL in 1 BOTTLE, PUMPLOTION9466
52854-950-05Land Shark SPF 503785 mL in 1 JUGLOTION37856

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52854-950LAND SHARK SPF 50 (OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.]5Current NDC, Legacy NDC, 5 package rows20241103_b4cc95f0-d684-5331-e053-2995a90a3295.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 118 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC39959db9-5ee1-a27c-e063-6394a90a1e102025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995f556-20fe-3e64-e063-6294a90a5efe2025-12-15Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995385b-b10b-ca5c-e063-6294a90af43f2025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3994aa84-30b4-3dc4-e063-6394a90a23e72025-12-15Exact identifier
application number: M020
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC39947913-f1cc-25d2-e063-6294a90a42292025-12-15Exact identifier
application number: M020
Non Tinted Mineral SunscreenZINC OXIDEMicro Fibro Blast35425e24-3e2c-51db-e063-6394a90a55802025-12-15Exact identifier
application number: M020
Solar Shield TintedZINC OXIDEDENISE BELL SKIN CARE396fe2ca-eb29-5952-e063-6294a90ab2792025-12-15Exact identifier
application number: M020
Solar Shield TintedZINC OXIDEDENISE BELL SKIN CARE396f91b3-3326-3239-e063-6294a90a5df92025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEMicro Fibro Blast35422370-eb55-049c-e063-6294a90ad0a42025-12-15Exact identifier
application number: M020
Eclipse Face TintedZINC OXIDEDENISE BELL SKIN CARE396f0151-2d0d-f4da-e063-6394a90a5f7f2025-12-15Exact identifier
application number: M020
Eclipse Body Non TintedZINC OXIDEDENISE BELL SKIN CARE396f56df-d0de-1344-e063-6294a90a46ea2025-12-15Exact identifier
application number: M020
Solar Shield TintedTITANIUM DIOXIDE, ZINC OXIDEDENISE BELL SKIN CARE396eb781-5947-3665-e063-6294a90a38dd2025-12-15Exact identifier
application number: M020
Sun Veil Illuminating Sunscreen SPF30ZINC OXIDEKoco Life LLC46001097-540e-65da-e063-6294a90af2992025-12-15WarningsExact identifier
application number: M020
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC3542d8d3-35a3-7d63-e063-6394a90a6fd12025-12-15Exact identifier
application number: M020
Mineral Primer non-tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC354357de-1a85-3bdb-e063-6294a90aa9a22025-12-15Exact identifier
application number: M020
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC35433254-1dc8-a8f3-e063-6394a90a29f02025-12-15Exact identifier
application number: M020
Sun Therapy SunscreenZINC OXIDESkin Therapy Studio LLC3544916b-3f63-3a7a-e063-6394a90ae5072025-12-15Exact identifier
application number: M020
Ultra Zinc Mineral Non TintedZINC OXIDESkin Therapy Studio LLC3545d603-3d01-c51d-e063-6394a90a15992025-12-15Exact identifier
application number: M020
Sun Therapy SunscreenZINC OXIDESkin Therapy Studio LLC357efafb-aa1c-0d69-e063-6394a90a51352025-12-15Exact identifier
application number: M020
Ultra Zinc Mineral Non TintedZINC OXIDESkin Therapy Studio LLC35806102-6919-116f-e063-6294a90ad9222025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52854-950-015285409500160 mL in 1 BOTTLE, PLASTIC (52854-950-01) 60 ml2020-06-290000-00-00NoNoCurrent
52854-950-0252854095002120 mL in 1 BOTTLE, PLASTIC (52854-950-02) 120 ml2020-07-220000-00-00NoNoCurrent
52854-950-0352854095003192 mL in 1 BOTTLE, PLASTIC (52854-950-03) 192 ml2020-02-140000-00-00NoNoCurrent
52854-950-0452854095004946 mL in 1 BOTTLE, PUMP (52854-950-04) 946 ml2020-06-290000-00-00NoNoCurrent
52854-950-05528540950053785 mL in 1 JUG (52854-950-05) 3785 ml2020-06-290000-00-00NoNoCurrent