Home NDC 43419-791 LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50
Product NDC 43419-791
11-digit product format 434190791
Labeler code 43419
Product ID 43419-791_23f95123-0659-d024-e063-6294a90a9875
Type HUMAN OTC DRUG
Nonproprietary name Octocrylene, Homosalate, Octisalate, Avobenzone
Dosage form CREAM
Route TOPICAL
Labeler AMOREPACIFIC CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-01
Substance HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE
Active strength 3.5; 1.25; 4.5; 2.25 g/50mL; g/50mL; g/50mL; g/50mL
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 LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 3.5 g/50mL AVOBENZONE 1.25 g/50mL OCTOCRYLENE 4.5 g/50mL OCTISALATE 2.25 g/50mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
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 43419-791-08 LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50 50 mL in 1 TUBE CREAM 50 2 43419-791-08 LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50 1 in 1 BOX CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43419-791 LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50 (OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE) CREAM [AMOREPACIFIC CORPORATION] 2 Current NDC, 2 package rows 20241010_0e746836-ed84-7b33-e063-6294a90aeff3.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 354 · 7,077 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43419-791-08 43419079108 1 TUBE in 1 BOX (43419-791-08) / 50 mL in 1 TUBE 1 tube 2024-05-01 No No Current