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 204 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Counter Beauty Dew Skin Tinted Moisturizer No. 4ZINC OXIDEG2G Ventures, PBC3a35f23b-3732-db3c-e063-6294a90ae00c2025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 5ZINC OXIDEG2G Ventures, PBC3a35fd79-f4d3-5ccf-e063-6294a90a97982025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 6ZINC OXIDEG2G Ventures, PBC3a360053-5863-95fe-e063-6394a90a45c52025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 8ZINC OXIDEG2G Ventures, PBC3a362e05-3a1e-8059-e063-6294a90ad5252025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 7ZINC OXIDEG2G Ventures, PBC3a3621c2-709a-82fd-e063-6294a90a7a7e2025-07-18WarningsExact identifier
application number: M020
Basin Pina Colada SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc3a39ac31-85c9-5e04-e063-6394a90aa5372025-07-18WarningsExact identifier
application number: M020
Basin American Pink Lemonade SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3afeda-f235-eac2-e063-6294a90a5a932025-07-18WarningsExact identifier
application number: M020
Basin Chinese Mandarin SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3b5f56-aa36-01c7-e063-6294a90a6d622025-07-18WarningsExact identifier
application number: M020
Counter Beauty Daily Sheer Defense SPF 25ZINC OXIDEG2G Ventures, PBC3a22d88b-cdb5-5656-e063-6294a90a5b772025-07-17WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 1ZINC OXIDEG2G Ventures, PBC3a2676ed-087d-f957-e063-6294a90ad4572025-07-17WarningsExact identifier
application number: M020
Sjolie Tanning SPF 30 SunscreenZINC OXIDESJOLIE, INC.3a283a09-2edb-f92c-e063-6294a90a82bd2025-07-17WarningsExact identifier
application number: M020
Neutrogena Clear Body Breakout Free Oil Free Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC32889c1e-d539-4b36-b012-9789c4a8d6422025-07-16WarningsExact identifier
application number: M020
GZE Tinted SunscreenZINC OXIDE 3%Guangzhou Yilong Cosmetics Co.,Ltd.182612d8-76a4-44a1-e063-6394a90a8d5f2025-07-15WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC089b798b-829f-aa86-e063-6294a90a86312025-07-15WarningsExact identifier
application number: M020
MO HANDSOME Protection Sport Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENE8 PINE DESIGN LLC982ada30-5f87-42c6-b9ea-fedd842aa09d2025-07-15WarningsExact identifier
application number: M020
Amarte ULTRA VEIL DailySUNSCREENAmarte USA LLC39e9ca98-d0e8-6b8f-e063-6394a90aa3662025-07-15WarningsExact identifier
application number: M020
Amarte ULTRA VEIL BB FairSUNSCREENAmarte USA LLC39e87950-4103-c2eb-e063-6394a90a05522025-07-15WarningsExact identifier
application number: M020
LEBELAGE UV SUN ULTRA SHIELD SUNSTICKAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATEDONGDONGGURIMOO CO.,LTD.39eea41c-8703-cf1f-e063-6394a90a5b1f2025-07-14WarningsExact identifier
application number: M020
Basin Vanilla SPF 30 Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.4a8e7be0-97a6-ada5-e063-6294a90ae25a2025-07-14WarningsExact identifier
application number: M020
Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc48980ef3-ebda-450e-9f15-effad27dec9a2025-07-11WarningsExact 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