SHISEIDO URBAN ENVIRONMENT OIL-FREE SUNSCREEN SPF 42- ensulizole, homosalate, octisalate, 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.

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SHISEIDO URBAN ENVIRONMENT OIL-FREE SUNSCREEN SPF 42

Drug Facts

Active ingredientsPurpose
ENSULIZOLE 1.0%Sunscreen
HOMOSALATE 15.0%Sunscreen
OCTISALATE 5.0%Sunscreen
ZINC OXIDE 15.5%Sunscreen

Uses

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.

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

Directions

For sunscreen use:

Inactive Ingredients

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

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
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 SUNSCREEN SPF 42 
ensulizole, homosalate, octisalate, and zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-670
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE0.4 g  in 30 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5.4 g  in 30 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.8 g  in 30 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.6 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
GLYCERIN (UNII: PDC6A3C0OX)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
TREHALOSE (UNII: B8WCK70T7I)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
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)  
GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I)  
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
TROLAMINE (UNII: 9O3K93S3TK)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALCOHOL (UNII: 3K9958V90M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
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:58411-670-101 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: 0925ed68-22fe-456d-bb88-9c8dcfae64ea
Set id: 21bde283-a554-45c8-8733-2a8adeff41b1
Version: 1
Effective Time: 20211115
 
SHISEIDO AMERICAS CORPORATION