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 13 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VERSED MULTI SERUM SKIN TINT SPF 40 DEEP WRM ZINC OXIDE COSMAX USA, CORP 5647ae2c-bcba-63c0-e063-6394a90ad5bc 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP WRM ZINC OXIDE COSMAX USA, CORP 56478f3d-f25c-bef7-e063-6294a90ade09 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP COOL ZINC OXIDE COSMAX USA, CORP 564796f8-072f-61f2-e063-6394a90ab394 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 DEEP COOL ZINC OXIDE COSMAX USA, CORP 5647e63c-a695-1b40-e063-6394a90a5767 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 DEEP NEUTRAL ZINC OXIDE COSMAX USA, CORP 5647d0f1-945f-b0b7-e063-6294a90aafe2 2026-07-10 Warnings Exact identifier application number: M020 LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 Sunset Sands ZINC OXIDE COSMAX USA, CORP 5648da76-5a67-605a-e063-6294a90a4e3b 2026-07-10 Warnings Exact identifier application number: M020 Coco and Eve Tan Boosting Anti Aging Body Oil SPF 45 HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE COSMAX USA, CORP 5648d637-9743-97a7-e063-6294a90ad8a1 2026-07-10 Warnings Exact identifier application number: M020 The Mineral Lip One SPF 45 Nourishing Lip Tint Vanilla Cloud ZINC OXIDE COSMAX USA, CORP 5648c90b-b814-c16e-e063-6394a90a3e1f 2026-07-10 Warnings Exact identifier application number: M020 The Mineral Lip One SPF 45 Nourishing Lip Tint Berry Balmy ZINC OXIDE COSMAX USA, CORP 56490982-200d-e3a7-e063-6394a90a72a4 2026-07-10 Warnings Exact identifier application number: M020 PRIME Prometics LipOil SPF 35 Warm Sienna ZINC OXIDE COSMAX USA, CORP 56491794-712d-1306-e063-6394a90a4707 2026-07-10 Warnings Exact identifier application number: M020 PRIME Prometics LipOil SPF 35 Bright Berry ZINC OXIDE COSMAX USA, CORP 56491833-5053-c85e-e063-6294a90ac4f5 2026-07-10 Warnings Exact identifier application number: M020 PRIME Prometics LipOil SPF 35 Nude Rose ZINC OXIDE COSMAX USA, CORP 56493964-1d5b-2fc7-e063-6394a90a7492 2026-07-10 Warnings Exact identifier application number: M020 PRIME Prometics LipOil SPF 35 Soft Petal ZINC OXIDE COSMAX USA, CORP 5649df7b-9d2c-d8eb-e063-6394a90acf99 2026-07-10 Warnings Exact identifier application number: M020 PRIME Prometics LipOil SPF 35 Nude Glow ZINC OXIDE COSMAX USA, CORP 564a6566-442c-b933-e063-6294a90a6f9b 2026-07-10 Warnings Exact identifier application number: M020 SOFIE PAVITT FACE SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE COSMAX USA., CORP 564ae5d2-1504-9623-e063-6394a90a2fa5 2026-07-10 Warnings Exact identifier application number: M020 IDEALOVE HYDROGLOW DAILY SUNSCREEN SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE COSMAX USA, CORP 564b284c-3248-c6c0-e063-6394a90a1103 2026-07-10 Warnings Exact identifier application number: M020 SOFIE PAVITT FACE SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE COSMAX USA., CORP 564b1ed2-aa98-a334-e063-6294a90a169b 2026-07-10 Warnings Exact identifier application number: M020 LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 GOLDEN HOUR ZINC OXIDE COSMAX USA, CORP 564b559e-6fe8-e98e-e063-6294a90a8f0e 2026-07-10 Warnings Exact identifier application number: M020 LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 BLISS ON THE BEACH ZINC OXIDE COSMAX USA, CORP 564b63f2-701e-f5bd-e063-6394a90af797 2026-07-10 Warnings Exact identifier application number: M020 LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 GOING COCONUTS ZINC OXIDE COSMAX USA, CORP 564b5ab3-0a7c-f663-e063-6394a90a0c3d 2026-07-10 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