Home NDC 43419-085 Sulwhasoo UV Daily Cream
Product NDC 43419-085
11-digit product format 434190085
Labeler code 43419
Product ID 43419-085_243ae506-aa4b-da8e-e063-6394a90a815d
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene Cream
Dosage form CREAM
Route TOPICAL
Labeler Amorepacific Corporation
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-05-31
Substance HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength 3.6; 1.8; 1; 3.6 g/40mL; g/40mL; g/40mL; g/40mL
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 Sulwhasoo UV Daily Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 3.6 g/40mL OCTISALATE 1.8 g/40mL AVOBENZONE 1 g/40mL OCTOCRYLENE 3.6 g/40mL
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 43419-085-19 Sulwhasoo UV Daily Cream 1 in 1 CARTON CREAM 1 4 43419-085-19 Sulwhasoo UV Daily Cream 40 mL in 1 TUBE CREAM 40 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43419-085 SULWHASOO UV DAILY CREAM (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM) CREAM [AMOREPACIFIC CORPORATION] 4 Current NDC, Legacy NDC, 2 package rows 20241013_e00451d5-8433-c4e8-e053-2a95a90a6244.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 43419-085-19 43419008519 1 TUBE in 1 CARTON (43419-085-19) / 40 mL in 1 TUBE 1 tube 2022-05-31 0000-00-00 No No Current