FDA.reportPublic FDA data

Land Shark SPF 40

Product NDC
52854-403
11-digit product format
528540403
Labeler code
52854
Product ID
52854-403_42c9ea9f-5a54-f1a4-e063-6294a90a3298
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide and titanium dioxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Tropical Seas, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-25
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
13; 4.2 g/100g; g/100g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 40
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE13 g/100g
TITANIUM DIOXIDE4.2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d204c38c-b5d1-3511-e053-2a95a90a9dc8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52854-403-01Land Shark SPF 4085 g in 1 TUBELOTION855

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52854-403LAND SHARK SPF 40 (ZINC OXIDE AND TITANIUM DIOXIDE) LOTION [TROPICAL SEAS, INC.]4Current NDC, Legacy NDC, 1 package rows20241103_d204c38c-b5d1-3511-e053-2a95a90a9dc8.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 125 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
20Percent Zinc Oxide SunscreenZINC OXIDEMinder Day Spa, Inc.35bee5f9-68d6-6302-e063-6394a90ada882025-12-15Exact identifier
application number: M020
20Percent Zinc Oxide SunscreenZINC OXIDEMinder Day Spa, Inc.35bfd54a-d7b7-f1a7-e063-6294a90a039b2025-12-15Exact identifier
application number: M020
AM RESTOREZINC OXIDEMinder Day Spa, Inc.35c03804-04e9-3d54-e063-6294a90a34072025-12-15Exact identifier
application number: M020
Deflectin Tinted Mineral SunscreenZINC OXIDEAEON AESTHETICS LLC35d14660-8900-2cb0-e063-6394a90a317d2025-12-15Exact identifier
application number: M020
Mineral Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf36c1-50c9-e848-e063-6294a90a66582025-12-15Exact identifier
application number: M020
Flash Invisible StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d2489e-4978-4fc3-e063-6294a90adfcc2025-12-15Exact identifier
application number: M020
AM RESTOREZINC OXIDEMinder Day Spa, Inc.35c010ad-e25d-f197-e063-6294a90a0efb2025-12-15Exact identifier
application number: M020
Flash Tinted StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d28590-e746-7996-e063-6294a90ac7d82025-12-15Exact identifier
application number: M020
Mineral Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf03f4-200a-5643-e063-6394a90a9e022025-12-15Exact identifier
application number: M020
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf708c-244e-63a8-e063-6394a90a3b962025-12-15Exact identifier
application number: M020
Daily RestoreZINC OXIDETYRLIN ENTERPRISES, INC.35cead50-86a7-2cf2-e063-6294a90a5f992025-12-15Exact identifier
application number: M020
Daily Defense Facial Sunscreen Plus PrimerTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e81e8e-0ba7-93e6-e063-6294a90a4e622025-12-15Exact identifier
application number: M020
Sacred AuraZINC OXIDEIRIA SKIN OASIS LLC36eaaa54-e288-6590-e063-6394a90a403d2025-12-15Exact identifier
application number: M020
Daily Defense Facial Sunscreen Plus PrimerTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e84147-5dcd-517a-e063-6394a90a54ee2025-12-15Exact identifier
application number: M020
Sacred GlowZINC OXIDEIRIA SKIN OASIS LLC36ead65c-a46c-7395-e063-6394a90a9e042025-12-15Exact identifier
application number: M020
Sheer Mineral Face And Body Sunscreen Non TintedZINC OXIDELAURA CATHERINE, LLC36e91877-c4c4-7fa3-e063-6294a90a13262025-12-15Exact identifier
application number: M020
Sheer Mineral Face And Body Sunscreen TintedZINC OXIDELAURA CATHERINE, LLC36e880af-debc-657f-e063-6394a90ab6ff2025-12-15Exact identifier
application number: M020
Sheer Mineral Face And Body Sunscreen TintedZINC OXIDELAURA CATHERINE, LLC36e8b631-03e7-c1de-e063-6294a90aa5302025-12-15Exact identifier
application number: M020
Sheer Mineral Face And Body Sunscreen Non TintedZINC OXIDELAURA CATHERINE, LLC36e957cf-cfa5-b122-e063-6294a90a78ce2025-12-15Exact identifier
application number: M020
Skin Shield PlusZINC OXIDELAURA CATHERINE, LLC36e9c2f3-ea89-0de3-e063-6394a90a9fb62025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52854-403-015285404030185 g in 1 TUBE (52854-403-01) 85 g2021-10-250000-00-00NoNoCurrent