FDA.reportPublic FDA data

SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42

Manufacturer
SHISEIDO AMERICAS CORPORATION
Effective date
2025-03-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:57:25

Label at a glance#

ProductSHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42
Active ingredientENSULIZOLE, HOMOSALATE, OCTISALATE, ZINC OXIDE
Label structure9 sections

Indications and uses

helps 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 protection measures including: lim...

Storage and handling

protect this product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

  • helps 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.

SPL UNCLASSIFIED 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 Ingredients

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 sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

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

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-670-10SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 4230 mL in 1 BOTTLEEMULSION304
58411-670-10SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 421 in 1 CARTONEMULSION14
58411-670-11SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 4250 mL in 1 BOTTLEEMULSION504
58411-670-11SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 421 in 1 CARTONEMULSION14
58411-670-12SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42143 mL in 1 BOTTLEEMULSION1434
58411-670-12SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 421 in 1 CARTONEMULSION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-670SHISEIDO URBAN ENVIRONMENT OIL-FREE SUNSCREEN SPF 42 (ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDE) EMULSION [SHISEIDO AMERICAS CORPORATION]4Current NDC, Legacy NDC, 6 package rows20250322_21bde283-a554-45c8-8733-2a8adeff41b1.zip

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-67058411-670-10, 58411-670-11, 58411-670-12

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
ENSULIZOLE9YQ9DI1W42ACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
TRISILOXANE9G1ZW13R0GIACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PEG/PPG-14/7 DIMETHYL ETHER6DNW9T7YT2IACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
TREHALOSEB8WCK70T7IIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
ETHYLHEXYL PALMITATE2865993309IACT
DEXTRIN PALMITATE (CORN; 20000 MW)89B2BSF9I3IACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
ASCORBYL TETRAISOPALMITATE47143LT58AIACT
THIOTAURINENQZ2D7AO62IACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
PAEONIA LACTIFLORA ROOT3Z3866YW6PIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SANGUISORBA OFFICINALIS ROOT4NYV2HT01XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
GARCINIA MANGOSTANA BARKN6A4WY566IIACT
PERILLA FRUTESCENS LEAFT4L5881Y68IACT
TROLAMINE9O3K93S3TKIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
EDETATE DISODIUM7FLD91C86KIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ALCOHOL3K9958V90MIACT
ISOSTEARIC ACIDX33R8U0062IACT
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOLKD6TZ2QICHIACT
SODIUM METABISULFITE4VON5FNS3CIACT
BARIUM SULFATE25BB7EKE2EIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT

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 ENVIRONMENT Oil-Free SUNSCREEN SPF 42ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION21bde283-a554-45c8-8733-2a8adeff41b12025-03-20WarningsExact identifier
ndc (package): 58411-670-12
ndc (package): 58411-670-10
ndc (package): 58411-670-11
ndc (product): 58411-670
ndc11 (package): 58411067011
ndc11 (package): 58411067010
ndc11 (package): 58411067012
spl id: c3672661-2ff1-4696-917c-47ac9136f7fe
spl set id: 21bde283-a554-45c8-8733-2a8adeff41b1

Reported adverse events (FAERS/openFDA)#

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