FDA.reportPublic FDA data

SHISEIDO URBAN ENVIRONMENT

Manufacturer
Shiseido Americas Corporation | Shiseido America Inc.
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:25:56

Label at a glance#

ProductSHISEIDO URBAN ENVIRONMENT
Active ingredientENSULIZOLE, HOMOSALATE, OCTISALATE, ZINC OXIDE
Label structure14 sections

Indications and uses

help prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply:       • after 40 minutes of swimming or sweating       • immediately after towel drying       • at least every 2 hours Sun Protection Measures.  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protecti...

Storage and handling

protect this product in this container from excessive heat and direct sunlight

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE SECTION

Active ingredientsPurpose
Ensulizole 1.0%Sunscreen
Homosalate 15.0%Sunscreen
Octisalate 5.0%Sunscreen
Zinc Oxide 15.5%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • help prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

WARNINGS AND PRECAUTIONS SECTION

Flammable: Do not use near heat, flame, or while smoking

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply:

      • after 40 minutes of swimming or sweating

      • immediately after towel drying

      • at least every 2 hours

  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

      • limit time in the sun, especially from 10 a.m. - 2 p.m.

      • wear long-sleeve shirts, pants, hats, and sunglasses

      • children under 6 months: Ask a doctor


INACTIVE INGREDIENT SECTION

WATER･DIMETHICONE･TRISILOXANE･SD ALCOHOL 40-B･ZINC OXIDE･GLYCERIN･SILICA･PEG/PPG-14/7 DIMETHYL ETHER･LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE･PEG-10 DIMETHICONE･TREHALOSE･MYRISTYL MYRISTATE･ETHYLHEXYL PALMITATE･DEXTRIN PALMITATE･ISODECYL NEOPENTANOATE･ASCORBYL TETRAISOPALMITATE･THIOTAURINE･DIPOTASSIUM GLYCYRRHIZATE･SCUTELLARIA BAICALENSIS ROOT EXTRACT･PAEONIA ALBIFLORA ROOT EXTRACT･SODIUM HYALURONATE･SANGUISORBA OFFICINALIS ROOT EXTRACT･CAMELLIA SINENSIS LEAF EXTRACT･GARCINIA MANGOSTANA BARK EXTRACT･PERILLA OCYMOIDES LEAF EXTRACT･SPIRULINA PLATENSIS EXTRACT･TRIETHANOLAMINE･TRIETHOXYCAPRYLYLSILANE･BUTYLENE GLYCOL･DISODIUM EDTA･DISTEARDIMONIUM HECTORITE･TOCOPHEROL･BHT･ALCOHOL･ISOSTEARIC ACID･MENTHOXYPROPANEDIOL･SODIUM METABISULFITE･POLYSILICONE-2･BARIUM SULFATE･SODIUM CITRATE･PHENOXYETHANOL･BENZOIC ACID･FRAGRANCE･IRON OXIDES･

Other information

STORAGE AND HANDLING SECTION

  • protect this product in this container from excessive heat and direct sunlight

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO 

Ginza Tokyo

Urban Environment

Sun Dual Care

OIL-FREE

with HYALURONIC ACID

SPF 42

BROAD SPECTRUM SPF 42

WATER RESISTANT (40 MINUTES)

SUNSCREEN

50mL 1.6 FL. OZ.

urban environment oil free labelurban environment oil free label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-952-10SHISEIDO URBAN ENVIRONMENT50 mL in 1 BOTTLE, PLASTICEMULSION502
58411-952-10SHISEIDO URBAN ENVIRONMENT1 in 1 BOXEMULSION12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-95258411-952-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
TRISILOXANE9G1ZW13R0GIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
SILICAETJ7Z6XBU4IACT
PEG/PPG-14/7 DIMETHYL ETHER6DNW9T7YT2IACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
PEG-10 DIMETHICONE (200 CST)287GF3Y3WCIACT
TREHALOSEB8WCK70T7IIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
ETHYLHEXYL PALMITATE2865993309IACT
DEXTRIN PALMITATE (CORN; 20000 MW)89B2BSF9I3IACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
ASCORBYL TETRAISOPALMITATE47143LT58AIACT
THIOTAURINENQZ2D7AO62IACT
DIPOTASSIUM GLYCYRRHIZATECA2Y0FE3FXIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
PAEONIA ALBIFLORA FLOWERR73687A534IACT
SODIUM HYALURONATEYSE9PPT4THIACT
SANGUISORBA OFFICINALIS ROOT4NYV2HT01XIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
GARCINIA MANGOSTANA BARKN6A4WY566IIACT
PERILLA OCYMOIDES SEED OIL322MS57V7ZIACT
SPIRULINA PLATENSIS9L3TIH1UUEIACT
TRIETHANOLAMINE9O3K93S3TKIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
EDETATE DISODIUM7FLD91C86KIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
TOCOPHEROLR0ZB2556P8IACT
BHT1P9D0Z171KIACT
ISOSTEARIC ACIDX33R8U0062IACT
MENTHOXYPROPANEDIOLKD6TZ2QICHIACT
SODIUM METABISULFITE4VON5FNS3CIACT
BARIUM SULFATE25BB7EKE2EIACT
SODIUM CITRATE1Q73Q2JULRIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZOIC ACID8SKN0B0MIMIACT
FERRIC OXIDE RED1K09F3G675IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO URBAN ENVIRONMENTENSULIZOLE, HOMOSALATE, OCTISALATE, ZINC OXIDEShiseido Americas Corporation8db9f5e0-a8d6-4872-b4c6-cb92c43d25c22025-12-16WarningsExact identifier
ndc (package): 58411-952-10
ndc (product): 58411-952
ndc11 (package): 58411095210
spl id: 4617da57-c5ae-99fc-e063-6394a90ac726
spl set id: 8db9f5e0-a8d6-4872-b4c6-cb92c43d25c2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.