Home NDC 58411-670 SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42
Product NDC 58411-670
11-digit product format 584110670
Labeler code 58411
Product ID 58411-670_c3672661-2ff1-4696-917c-47ac9136f7fe
Type HUMAN OTC DRUG
Nonproprietary name ensulizole, homosalate, octisalate, and zinc oxide
Dosage form EMULSION
Route TOPICAL
Labeler SHISEIDO AMERICAS CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-01-01
Substance ENSULIZOLE; HOMOSALATE; OCTISALATE; ZINC OXIDE
Active strength .4; 5.4; 1.8; 5.6 g/30mL; g/30mL; g/30mL; g/30mL
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 SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENSULIZOLE .4 g/30mL HOMOSALATE 5.4 g/30mL OCTISALATE 1.8 g/30mL ZINC OXIDE 5.6 g/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 58411-670-10 SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42 30 mL in 1 BOTTLE EMULSION 30 4 58411-670-10 SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42 1 in 1 CARTON EMULSION 1 4 58411-670-11 SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42 50 mL in 1 BOTTLE EMULSION 50 4 58411-670-11 SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42 1 in 1 CARTON EMULSION 1 4 58411-670-12 SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42 143 mL in 1 BOTTLE EMULSION 143 4 58411-670-12 SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42 1 in 1 CARTON EMULSION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58411-670 SHISEIDO URBAN ENVIRONMENT OIL-FREE SUNSCREEN SPF 42 (ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDE) EMULSION [SHISEIDO AMERICAS CORPORATION] 4 Current NDC, Legacy NDC, 6 package rows 20250322_21bde283-a554-45c8-8733-2a8adeff41b1.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 58411-670-10 58411067010 1 BOTTLE in 1 CARTON (58411-670-10) / 30 mL in 1 BOTTLE 1 bottle 2022-01-01 0000-00-00 No No Current 58411-670-11 58411067011 1 BOTTLE in 1 CARTON (58411-670-11) / 50 mL in 1 BOTTLE 1 bottle 2022-01-01 No No Current 58411-670-12 58411067012 1 BOTTLE in 1 CARTON (58411-670-12) / 143 mL in 1 BOTTLE 1 bottle 2022-01-01 No No Current