Home NDC 52854-945 Land Shark SPF 45
Product NDC 52854-945
11-digit product format 528540945
Labeler code 52854
Product ID 52854-945_42c939fa-26c8-56db-e063-6394a90a32b4
Type HUMAN OTC DRUG
Nonproprietary name octocrylene, octinoxate, oxybenzone, homosalate and octisalate
Dosage form LOTION
Route TOPICAL
Labeler Tropical Seas, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-07-22
Substance OCTOCRYLENE; OCTINOXATE; OXYBENZONE; HOMOSALATE; OCTISALATE
Active strength 8; 7.5; 6; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
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 45
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 8 g/100mL OCTINOXATE 7.5 g/100mL OXYBENZONE 6 g/100mL HOMOSALATE 5 g/100mL OCTISALATE 5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52854-945-01 Land Shark SPF 45 120 mL in 1 BOTTLE, PLASTIC LOTION 120 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52854-945 LAND SHARK SPF 45 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE) LOTION [TROPICAL SEAS, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20241103_b4cafdf1-44e1-10c0-e053-2995a90ab3dc.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 302 of 346 · 6,912 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 52854-945-01 52854094501 120 mL in 1 BOTTLE, PLASTIC (52854-945-01) 120 ml 2020-07-22 0000-00-00 No No Current