Home NDC 58411-854 SHISEIDO URBAN ENVIRONMENT VITA-CLEAR SUNSCREEN
Product NDC 58411-854
11-digit product format 584110854
Labeler code 58411
Product ID 58411-854_4a015504-361a-c6b2-e063-6394a90ad6b5
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE
Dosage form EMULSION
Route TOPICAL
Labeler SHISEIDO AMERICAS CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-12-25
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 690; 3000; 1500; 1500 mg/30mL; mg/30mL; mg/30mL; mg/30mL
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 VITA-CLEAR SUNSCREEN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 690 mg/30mL HOMOSALATE 3000 mg/30mL OCTISALATE 1500 mg/30mL OCTOCRYLENE 1500 mg/30mL
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 58411-854-20 SHISEIDO URBAN ENVIRONMENT VITA-CLEAR SUNSCREEN 1 in 1 BOX EMULSION 1 3 58411-854-40 SHISEIDO URBAN ENVIRONMENT VITA-CLEAR SUNSCREEN 30 mL in 1 BOTTLE, PLASTIC EMULSION 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58411-854 SHISEIDO URBAN ENVIRONMENT VITA-CLEAR SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) EMULSION [SHISEIDO AMERICAS CORPORATION] 2 Current NDC, Legacy NDC, 2 package rows 20241225_60e55ebb-47b8-465e-819a-af195952e1ca.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 58411-854-20 58411085420 1 BOTTLE, PLASTIC in 1 BOX (58411-854-20) / 30 mL in 1 BOTTLE, PLASTIC (58411-854-40) 2022-08-01 0000-00-00 No No Current 58411-854-40 58411085440 30 mL in 1 BOTTLE, PLASTIC 30 ml Historical