SHISEIDO URBAN ENVIRONMENT OIL-FREE MINERAL SUNSCREEN SPF 42- titanium dioxide and zinc oxide emulsion 
SHISEIDO AMERICAS CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

SHISEIDO URBAN ENVIRONMENT OIL-FREE MINERAL SUNSCREEN SPF 42

Drug Facts

Active ingredientsPurpose
TITANIUM DIOXIDE 4.9%Sunscreen
ZINC OXIDE 13.6% Sunscreen

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

Warnings

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs.

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

Directions

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

DIMETHICONE • WATER • SILICA • ZINC OXIDE • DIPROPYLENE GLYCOL • GLYCERIN • CAPRYLYL METHICONE • DIPHENYLSILOXY PHENYL TRIMETHICONE • ISODODECANE • HYDROGENATED POLYDECENE • PEG/PPG-14/7 DIMETHYL ETHER • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 • PEG-10 DIMETHICONE • TREHALOSE • PHYTOSTERYL MACADAMIATE • ASCORBYL TETRAISOPALMITATE • THIOTAURINE • DIPOTASSIUM GLYCYRRHIZATE • SCUTELLARIA BAICALENSIS ROOT EXTRACT • PAEONIA ALBIFLORA ROOT EXTRACT • SODIUM HYALURONATE • SANGUISORBA OFFICINALIS ROOT EXTRACT • CAMELLIA SINENSIS LEAF EXTRACT • ONONIS SPINOSA ROOT EXTRACT • GARCINIA MANGOSTANA BARK EXTRACT • CURCUMA LONGA (TURMERIC) RHIZOME EXTRACT • PERILLA OCYMOIDES LEAF EXTRACT • SPIRULINA PLATENSIS EXTRACT • ALUMINUM HYDROXIDE • HYDROGEN DIMETHICONE • TRIETHOXYCAPRYLYLSILANE • BUTYLENE GLYCOL • ISOSTEARIC ACID • DISTEARDIMONIUM HECTORITE • TRISODIUM EDTA • SODIUM CITRATE • ALCOHOL • CITRIC ACID • SODIUM METABISULFITE • POLYSILICONE-2 • BARIUM SULFATE • SYZYGIUM JAMBOS LEAF EXTRACT • TOCOPHEROL • PHENOXYETHANOL • BENZOIC ACID • IRON OXIDES •

Other information

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

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

SHISEIDO
GINZA TOKYO

Urban Environment

Sun Dual Care™

OIL-FREE
MINERAL
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
SHISEIDO URBAN ENVIRONMENT OIL-FREE MINERAL SUNSCREEN SPF 42 
titanium dioxide and zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-672
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.8 g  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERIN (UNII: PDC6A3C0OX)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
ISODODECANE (UNII: A8289P68Y2)  
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
TREHALOSE (UNII: B8WCK70T7I)  
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
THIOTAURINE (UNII: NQZ2D7AO62)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)  
GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I)  
TURMERIC (UNII: 856YO1Z64F)  
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
ALCOHOL (UNII: 3K9958V90M)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-672-101 in 1 CARTON01/01/2022
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/2022
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Revised: 11/2021
Document Id: 0bb52f1e-60e1-4d57-af0e-b676a94a8ec7
Set id: 86630e82-f249-4866-82dd-3e21feb266c4
Version: 1
Effective Time: 20211115
 
SHISEIDO AMERICAS CORPORATION