Home NDC 58411-671 SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42
Product NDC 58411-671
11-digit product format 584110671
Labeler code 58411
Product ID 58411-671_4a014918-5ec5-c2ee-e063-6394a90ae746
Type HUMAN OTC DRUG
Nonproprietary name avobenzone, homosalate, octisalate, and octocrylene
Dosage form CREAM
Route TOPICAL
Labeler SHISEIDO AMERICAS CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-01-01
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 1.2; 5.2; 2.6; 2.6 g/50mL; g/50mL; g/50mL; g/50mL
NDC exclude flag No
Listing certified through 2027-12-31
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 SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 1.2 g/50mL HOMOSALATE 5.2 g/50mL OCTISALATE 2.6 g/50mL OCTOCRYLENE 2.6 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58411-671-60 SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42 50 mL in 1 TUBE CREAM 50 4 58411-671-60 SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42 1 in 1 CARTON CREAM 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58411-671 SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42 (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION] 2 Current NDC, Legacy NDC, 2 package rows 20241225_42adc51f-f500-485d-82a0-126672141262.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 58411-671-60 58411067160 1 TUBE in 1 CARTON (58411-671-60) / 50 mL in 1 TUBE 1 tube 2022-01-01 0000-00-00 No No Current