SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR- zinc oxide, homosalate, octocrylene, and octisalate 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 UV PROTECTOR

Drug Facts

Active ingredientsPurpose
HOMOSALATE 5.0%Sunscreen
OCTISALATE 5.0%Sunscreen
OCTOCRYLENE 5.0%Sunscreen
ZINC OXIDE 9.7%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∙ISODODECANE∙DIMETHICONE∙SD ALCOHOL 40-B∙DIPROPYLENE GLYCOL∙ETHYLHEXYL PALMITATE∙PEG-10 DIMETHICONE∙GLYCERIN∙POLYMETHYLSILSESQUIOXANE∙VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER∙POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER∙XYLITOL∙SILICA∙METHYL METHACRYLATE CROSSPOLYMER∙THIOTAURINE∙SCUTELLARIA BAICALENSIS ROOT EXTRACT∙PAEONIA ALBIFLORA ROOT EXTRACT∙ONONIS SPINOSA ROOT EXTRACT∙ECTOIN∙LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙HYDROGEN DIMETHICONE∙BUTYLENE GLYCOL∙DISODIUM EDTA∙DISTEARDIMONIUM HECTORITE∙TOCOPHEROL∙ALUMINUM HYDROXIDE∙TRIETHOXYCAPRYLYLSILANE∙SODIUM METABISULFITE∙SYZYGIUM JAMBOS LEAF EXTRACT∙PHENOXYETHANOL∙BENZOIC ACID∙FRAGRANCE∙TITANIUM DIOXIDE∙MICA∙

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 - 50 mL Bottle Carton

SHISEIDO
GINZA TOKYO

Urban Environment
Oil-Free UV Protector

42

BROAD SPECTRUM
SPF 42

For Face

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

50mL 1.6 FL. OZ.

Principal Display Panel - 50 mL Bottle Carton
SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR 
zinc oxide, homosalate, octocrylene, and octisalate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-627
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.16 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.65 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.65 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.65 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
GLYCERIN (UNII: PDC6A3C0OX)  
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
XYLITOL (UNII: VCQ006KQ1E)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
THIOTAURINE (UNII: NQZ2D7AO62)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
MICA (UNII: V8A1AW0880)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
ECTOINE (UNII: 7GXZ3858RY)  
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-627-601 in 1 CARTON01/01/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-627-611 in 1 CARTON01/01/2021
230 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/01/2021
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Revised: 1/2021
Document Id: e3297c17-4740-4d05-88b6-5d6ed6f31ecc
Set id: 0ea2ed93-f2a2-44a2-9580-45a5ac752abf
Version: 1
Effective Time: 20210112
 
SHISEIDO AMERICAS CORPORATION