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 128 of 357 · 7,139 matching rows.
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