Home NDC 52854-403 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 Ingredient Strength ZINC OXIDE 13 g/100g TITANIUM DIOXIDE 4.2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52854-403-01 Land Shark SPF 40 85 g in 1 TUBE LOTION 85 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52854-403 LAND SHARK SPF 40 (ZINC OXIDE AND TITANIUM DIOXIDE) LOTION [TROPICAL SEAS, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20241103_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 114 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Kind Restore Tinted Mineral Sunscreen ZINC OXIDE POLISH BEAUTY 3980d278-c0f4-2c59-e063-6394a90aac37 2025-12-16 Exact identifier application number: M020 Solar Eclipse Extreme Sunscreen ZINC OXIDE ULTRAVIOLET SKINCARE LLC 36bfa691-48c0-8033-e063-6294a90ad899 2025-12-16 Exact identifier application number: M020 Kind Restore Moisturizing Lip Balm TITANIUM DIOXIDE, ZINC OXIDE POLISH BEAUTY 39814e27-4f3f-5ee6-e063-6394a90a941b 2025-12-16 Exact identifier application number: M020 Yoali SPF 40 ZINC OXIDE YOALI STUDIO LLC 390b7f9c-bc04-80ec-e063-6294a90a4092 2025-12-16 Exact identifier application number: M020 Skin Defense Matte Tinted Sunscreen ZINC OXIDE Gentlehomme LLC 365eb727-3e7f-f1dd-e063-6394a90aa469 2025-12-16 Exact identifier application number: M020 Dr B Clinical Skin Care Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE NAIRA BABAIAN, M.D., P.A. 365da1f8-5250-7589-e063-6294a90a3e68 2025-12-16 Exact identifier application number: M020 Dr B Clinical Skin Care Non Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE NAIRA BABAIAN, M.D., P.A. 365d7564-3025-257b-e063-6294a90ad170 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE Gentlehomme LLC 365e7d8e-e3e0-4c08-e063-6294a90af415 2025-12-16 Exact identifier application number: M020 Daily Replenish mineral sunscreen ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 369896b1-f4b4-6201-e063-6394a90a5bca 2025-12-16 Exact identifier application number: M020 Zinc 20 mineral sunscreen face Plus body ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 36985373-22dd-2232-e063-6394a90a76fb 2025-12-16 Exact identifier application number: M020 Matte Defense Mineral Sunscreen non tinted TITANIUM DIOXIDE, ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 3698090a-1639-00f9-e063-6394a90a7dd1 2025-12-16 Exact identifier application number: M020 Daily Replenish mineral sunscreen ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 3698d309-b9bf-e197-e063-6294a90af5a1 2025-12-16 Exact identifier application number: M020 Zinc 20 mineral sunscreen face Plus body ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 3698f29e-5d80-94af-e063-6394a90a0489 2025-12-16 Exact identifier application number: M020 Tinted Mineral Primer SPF 40 TITANIUM DIOXIDE, ZINC OXIDE JOSEPHINA RAMIREZ 365cf2be-8862-3622-e063-6394a90ac4e3 2025-12-16 Exact identifier application number: M020 SANCTUARY Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CHAMPAGNE APOTHECARY LLC 365ca99c-c878-1f4b-e063-6394a90a1f53 2025-12-16 Exact identifier application number: M020 Tinted Mineral Defense SPF 40 ZINC OXIDE JOSEPHINA RAMIREZ 365d299a-5886-5597-e063-6394a90a336c 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE MILL VALLEY DERMATOLOGY, INC. 3b171a89-c757-47a1-e063-6294a90a7a64 2025-12-16 Warnings Exact identifier application number: M020 Tinted BB Cream ZINC OXIDE Eco Esthetics LLC 38f3e618-59e1-4504-e063-6394a90afa55 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE MADRE TIERRA, INC. 3f697463-d3db-7b73-e063-6394a90ac222 2025-12-16 Warnings Exact identifier application number: M020 Non-Tinted Replenishing Daily Protection ZINC OXIDE MADRE TIERRA, INC. 3f69d6f3-454b-e60a-e063-6394a90a8781 2025-12-16 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52854-403-01 52854040301 85 g in 1 TUBE (52854-403-01) 85 g 2021-10-25 0000-00-00 No No Current