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 273 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hawaiian TropicAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC77cdd346-d273-ed66-e053-2991aa0ae31d2024-10-31WarningsExact identifier
application number: M020
Hawaiian TropicAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC767accea-c5b2-32dc-e053-2991aa0a33382024-10-31WarningsExact identifier
application number: M020
ZO Skin Health Sheer Fluid Broad-Spectrum Sunscreen SPF 50ZINC OXIDEZO Skin Health, Inc.f218c158-19aa-ab90-e053-2a95a90aaef32024-10-31WarningsExact identifier
application number: M020
Banana BoatZINC OXIDEEdgewell Personal Care Brands LLC1ce728be-966e-b662-e063-6394a90a0ba82024-10-30WarningsExact identifier
application number: M020
RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENECOSMAX USA, INC.2596a17e-4042-3544-e063-6294a90aa4c92024-10-29WarningsExact identifier
application number: M020
SunbloczZINC OXIDEOlen Skin Care Corporation36fec1f1-5e8b-5764-e054-00144ff8d46c2024-10-29WarningsExact identifier
application number: M020
Sunblocz Baby and KidsZINC OXIDEOlen Skin Care Corporation35cbb9d5-639c-207a-e054-00144ff88e882024-10-29WarningsExact identifier
application number: M020
ZO Skin Health Daily Sheer Broad-Spectrum Sunscreen SPF 50 Water Resistant (40 Minutes)AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.fd7d40fe-178a-e1b1-e053-6294a90a29a12024-10-29WarningsExact identifier
application number: M020
ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZO Skin Health, Inc.9a4f5be1-da04-48b9-897a-57f4a3d9d1ec2024-10-29WarningsExact identifier
application number: M020
TiZO Ultra Zinc SPF 40 (Non-Tinted)ZINC OXIDEFallien Cosmeceuticals, LTDe4a06973-21bb-4eda-9b74-fc23bee141ab2024-10-29WarningsExact identifier
application number: M020
TiZO Ultra Zinc SPF 40 (Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD36efd48b-910e-4b61-9519-a6d5c7e9a7c32024-10-29WarningsExact identifier
application number: M020
ZO Skin Health Broad-Spectrum Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health, Inc.d817f80b-a998-b67e-e053-2995a90a19712024-10-29WarningsExact identifier
application number: M020
SPF 15 Coconut Lip BalmZINC OXIDENaples Soap Company, Inc.25a7510f-5ef3-9920-e063-6394a90a20792024-10-29WarningsExact identifier
application number: M020
Defense Total High Protection SPF 50 No Color Daily Non-Greasy Face ProtectionHOMOSALATE, OCTOCRYLENE, AVOBENZONEBel Star S.A. (Colombia)a7d69691-cecc-798e-e053-2a95a90a995f2024-10-28WarningsExact identifier
application number: M020
LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-FOCTINOXATE, ZINC OXIDEBel Star S.A.eea17271-e8c8-ab21-e053-2995a90a2fcc2024-10-28WarningsExact identifier
application number: M020
LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR SAfd90ffc6-a1e1-e02e-e053-6294a90a4e7c2024-10-28WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR S.A.0b782198-58e7-5343-e063-6294a90a37132024-10-28WarningsExact identifier
application number: M020
FHF Elevated Shade 100% Mineral SunscreenSUNSCREENOwen Biosciences Incdabd3b95-01d3-014c-e053-2a95a90a0fec2024-10-28WarningsExact identifier
application number: M020
RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBAY BELLE LABS259653e7-dfe0-44a2-e063-6294a90a416d2024-10-28WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC8a21acbe-2f3d-cf78-e053-2a95a90a77f62024-10-27WarningsExact 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