Home NDC 58411-970 SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN
Product NDC 58411-970
11-digit product format 584110970
Labeler code 58411
Product ID 58411-970_49a1ca55-4396-ace3-e063-6394a90ad478
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form CREAM
Route TOPICAL
Labeler Shiseido Americas Corporation
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-01
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 1.1845; 5.15; 2.575; 2.575 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 1.1845 g/50mL HOMOSALATE 5.15 g/50mL OCTISALATE 2.575 g/50mL OCTOCRYLENE 2.575 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 58411-970-60 SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN 50 mL in 1 TUBE CREAM 50 2 58411-970-60 SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN 1 in 1 BOX CREAM 1 2
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 342 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium Shade SPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADE Autumn Harp fd6807e1-c8c0-b361-e053-6294a90aea0c 2023-06-05 Warnings Exact identifier application number: M020 Thinksport Clear Zinc SPF 50 ZINC OXIDE thinkOperations,LLC b5ce523f-eee8-f1a8-da19-b3dc14f8a58e 2023-05-31 Warnings Exact identifier application number: M020 Thinksport Mineral SPF 50 ZINC OXIDE AND TITANIUM DIOXIDE thinkOperations,LLC 77b63c0b-353b-4f5f-95c7-6f7eeab81471 2023-05-30 Warnings Exact identifier application number: M020 Think Kids Mineral SPF 50 ZINC OXIDE AND TITANIUM DIOXIDE thinkOperations,LLC 25c59820-a08d-4abe-87ae-a787ac8b2ac2 2023-05-30 Warnings Exact identifier application number: M020 Topix Mineral Mattifying Tinted Sunscreeninted SPF 50 ZINC OXIDE Topiderm, Inc. 46c6f20f-4bb6-47c6-9eac-17ca97bb14a7 2023-03-20 Warnings Exact identifier application number: M020 Replenix Sunscreen SPF 50 ZINC OXIDE Topiderm, Inc. 9223ffa8-7af3-4407-9170-482afec536d8 2023-02-24 Warnings Exact identifier application number: M020 Bath and Body Works SPF20 Coconut Lip Balm SPF20 LIP BALM Autumn Harp f5744a48-2b39-4949-e053-2a95a90ab15d 2023-02-24 Warnings Exact identifier application number: M020 Replenix Tinted Sunscreen SPF 50 ZINC OXIDE AND OCTINOXATE Topiderm, Inc. 1fda4a54-e323-4f3c-b659-bded4b1b3dd0 2023-02-22 Warnings Exact identifier application number: M020 Topix Mineral Mattifying Tinted Sunscreen SPF 50 ZINC OXIDE Topiderm, Inc. ac5bbf3f-e1e0-4e03-bc5a-d6029dfb4e91 2023-02-22 Warnings Exact identifier application number: M020 Mineral Sunscreen SPF 50 ZINC OXIDE TITANIUM DIOXIDE Topiderm, Inc. 3a637542-0f79-47ae-815d-84d0036c737a 2023-02-13 Warnings Exact identifier application number: M020 Essential Moisturizing Sunscreen ZINC OXIDE, OCTINOXATE Topiderm, Inc. 450d916e-4c77-489e-86b1-78b686355476 2023-02-09 Warnings Exact identifier application number: M020 Mineral Repair SPF 45 ZINC OXIDE Topiderm, Inc. 84580f10-3119-4253-87a6-53d24a1f2227 2023-02-07 Warnings Exact identifier application number: M020 Think Aloe and Tea Leaves Zinc oxide ZINC OXIDE thinkOperations,LLC 9965ccd1-821d-4d9d-8a56-e87440b809ee 2023-02-02 Warnings Exact identifier application number: M020 Replenix Lip Therapy homosalate HOMOSALATE Topiderm, Inc. b60dc004-d713-47bc-a6e9-ea4783aa7019 2023-02-02 Warnings Exact identifier application number: M020 Josie Maran Argan Daily Moisturizer SPF47 ZINC OXIDE, TITANIUM DIOXIDE Autumn Harp, Inc. 027821e6-db7d-4c03-956a-00313488ebc7 2023-01-14 Boxed warning, Warnings Exact identifier application number: M020 Tinted Lip Balm SPF30 Wild Peony SPF30 LIP BALM Autumn Harp d0604720-623a-e8a9-e053-2995a90ab0e6 2023-01-10 Warnings Exact identifier application number: M020 Basin French Pear SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Retail Concepts of Minnesota, Inc. 3a39d91c-2dcf-71d6-e063-6394a90a5474 2022-02-10 Warnings Exact identifier application number: M020 Basin Mexican Vanilla SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Retail Concepts of Minnesota, Inc. 3a3a63d3-c7e0-bf03-e063-6394a90a1662 2022-02-10 Warnings Exact identifier application number: M020 Basin Norwegian Berry SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Retail Concepts of Minnesota, Inc. 3a3c0aa0-7501-7ef0-e063-6294a90a9f94 2022-02-10 Warnings Exact identifier application number: M020 Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 35 OCTINOXATE AND OXYBENZONE Groupe Marcelle Inc. c24ac3ad-b2e2-4381-bd80-a499da0e0670 2021-12-14 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58411-970-60 58411097060 1 TUBE in 1 BOX (58411-970-60) / 50 mL in 1 TUBE 1 tube 2025-02-01 No No Current