Home NDC 52854-908 Land Shark SPF 8
Product NDC 52854-908
11-digit product format 528540908
Labeler code 52854
Product ID 52854-908_42c9df65-9604-6288-e063-6394a90a8a30
Type HUMAN OTC DRUG
Nonproprietary name octinoxate and oxybenzone
Dosage form LOTION
Route TOPICAL
Labeler Tropical Seas, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-07-22
Substance OCTINOXATE; OXYBENZONE
Active strength 4.5; 1.5 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 8
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 4.5 g/100mL OXYBENZONE 1.5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup 95OOS7VE0Y Internal UNII lookup
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 52854-908-01 Land Shark SPF 8 192 mL in 1 BOTTLE, PLASTIC LOTION 192 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52854-908 LAND SHARK SPF 8 (OCTINOXATE AND OXYBENZONE) LOTION [TROPICAL SEAS, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20241103_b5e68448-4131-1c6c-e053-2a95a90a014a.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 26 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 52854-908-01 52854090801 192 mL in 1 BOTTLE, PLASTIC (52854-908-01) 192 ml 2020-07-22 0000-00-00 No No Current