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 19 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Not there spf broad spectrum spf40 moisturizer AVOBENZONE 3% ,HOMOSALATE 10% ,OCTISALATE 5% ,OCTOCRYLENE 8% ,ZINC OXIDE 4% Foshan Sugar Max Cosmetics CO.,Ltd 546f0474-4102-26d0-e063-6394a90a388b 2026-06-17 Warnings Exact identifier application number: M020 Ultra Violette Velvet Screen Blurring Mineral Skinscreen Broad Spectrum SPF 40 ZINC OXIDE Grace and Fire USA Inc. 52d4b1c1-7431-4f8c-e063-6294a90ad482 2026-06-17 Warnings Exact identifier application number: M020 EVIL GOODS TALLOW SUNSCREEN SPF30 ZINC OXIDE Moes Group LLC 54751f23-5723-0407-e063-6294a90a4a96 2026-06-17 Warnings Exact identifier application number: M020 Amber Sunglaze Sheer Body Mist Sunscreen SPF30 AVOBENZONE, OCTISALATE, OCTOCRYLENE Koco Life LLC 5478fb36-e972-f824-e063-6294a90a567f 2026-06-17 Warnings Exact identifier application number: M020 Elaine Sterling Hydrating Sunscreen ZINC OXIDE Elaine Sterling Enterprises 5479e862-aca5-7541-e063-6394a90ad0c5 2026-06-17 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE BCM Cosmetique SAS 545aa56a-ed07-acd6-e063-6394a90ae0c7 2026-06-16 Warnings Exact identifier application number: M020 MAYBELLINE NEW YORK FIT ME DEWY PLUS SMOOTH FOUNDATION SPF 18 SUNSCREEN OCTISALATE LOreal USA Products Inc 3b99ab06-ba4c-4ddd-a057-60028eedd67d 2026-06-16 Warnings Exact identifier application number: M020 TERRA LOTUS SPF 50 ORGANIC TALLOW SUNSCREEN ZINCOXIDE Moes Group LLC 54617bf2-1d8d-531e-e063-6294a90a7080 2026-06-16 Warnings Exact identifier application number: M020 Daily Defence Mineral Sunscreen SPF 50 Fragrance Free ZINC OXIDE Ultraceuticals Pty Ltd 5461ee82-0297-ce22-e063-6294a90a729b 2026-06-16 Warnings Exact identifier application number: M020 GlowBiotics Tinted Sunscreen SPF 30 ZINC OXIDE Rum Brands, LLC 544dba29-4785-4ab6-e063-6394a90a17b3 2026-06-16 Warnings Exact identifier application number: M020 Societe Prime and Defend ZINC OXIDE SUNSCREEN Societe Clinical Skincare 5439bd31-5ee1-9bca-e063-6394a90a748c 2026-06-16 Warnings Exact identifier application number: M020 Societe CoverShield Tinted SPF ZINC OXIDE Societe Clinical Skincare 545efbc4-82d4-f126-e063-6294a90a9710 2026-06-16 Warnings Exact identifier application number: M020 TITAN TALLOW SPF 50 ORGANIC TALLOW SUNSCREEN ZINC OXIDE Moes Group LLC 546b0702-a3cc-fd6f-e063-6394a90af849 2026-06-16 Warnings Exact identifier application number: M020 365 WHOLE FOODS MARKET MINERAL SPF 30 ZINC OXIDE Whole Foods Market, Inc. 5ce712d6-cafd-4a80-9f8c-2149fdebff54 2026-06-16 Warnings Exact identifier application number: M020 365 WHOLE FOODS MARKET MINERAL SPF 50 ZINC OXIDE Whole Foods Market, Inc. 1f8387be-d871-435b-baef-e537c67a510a 2026-06-15 Warnings Exact identifier application number: M020 365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 50 OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND HOMOSALATE Whole Foods Market, Inc. 82771f22-0197-40ba-97d2-2386152790ed 2026-06-15 Warnings Exact identifier application number: M020 365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 30 OCTOCRYLENE, OCTISALATE, AND AVOBENZONE Whole Foods Market, Inc. 1c31f466-6a0d-46ce-9346-d2a0eb46c8d0 2026-06-15 Warnings Exact identifier application number: M020 Shield by HEALTHY SKIN LAB MD SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE HEALTHY SKIN LAB LIMITED 6838b754-9915-48ff-af35-5338dbd06ac4 2026-06-15 Warnings Exact identifier application number: M020 Solvyn Mineral Sunscreen SPF 50 ZINC OXIDE Solvyn Skin LLC b0a8d028-87d2-4339-8879-c62cbf8415f2 2026-06-15 Warnings Exact identifier application number: M020 Amrit Ocean Resort Mineral Sunscreen SPF 50 ZINC OXIDE Solvyn Skin, LLC 112364cd-a445-46c2-b2f3-f9705d682cf6 2026-06-15 Warnings Exact identifier application number: M020
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