SHISEIDO URBAN ENVIRONMENT  OIL-FREE UV PROTECTOR- octinoxate, octocrylene, and zinc oxide lotion 
SHISEIDO AMERICA INC.

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 UV PROTECTOR
CREAM

Drug Facts

ACTIVE INGREDIENTS:Purpose
OCTINOXATE 4.9%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
ZINC OXIDE 12.5%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.

Directions

For sunscreen use:

Inactive Ingredients

WATER, DIMETHICONE, ISODODECANE, SD ALCOHOL 40-B, DIPROPYLENE GLYCOL, ETHYLHEXYL PALMITATE, PEG-10 DIMETHICONE, GLYCERIN, POLYMETHYLSILSESQUIOXANE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, XYLITOL, 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, ALUMINA, BHT, TRIETHOXYCAPRYLYLSILANE, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, BENZOIC ACID, FRAGRANCE, TITANIUM DIOXIDE, MICA,

Other information

Questions or comments?

Call toll free 1-800-906-7503

SHISEIDO AMERICA INC. NEW YORK, N.Y. 10022
SHISEIDO DIST. NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

SHISEIDO
GINZA TOKYO

Urban Environment
Oil-Free UV Protector

42

BROAD SPECTRUM
SPF 42

For Face

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
SHISEIDO URBAN ENVIRONMENT   OIL-FREE UV PROTECTOR
octinoxate, octocrylene, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-346
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1557 mg  in 31.77 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE953 mg  in 31.77 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3971 mg  in 31.77 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
XYLITOL (UNII: VCQ006KQ1E)  
THIOTAURINE (UNII: NQZ2D7AO62)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)  
ECTOINE (UNII: 7GXZ3858RY)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-346-101 in 1 CARTON10/01/2012
131.77 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:58411-346-802.12 g in 1 POUCH; Type 0: Not a Combination Product10/01/2012
3NDC:58411-346-111 in 1 CARTON10/01/2012
37.41 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/01/2012
Labeler - SHISEIDO AMERICA INC. (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132MANUFACTURE(58411-346) , ANALYSIS(58411-346)

Revised: 12/2019
Document Id: b6e0e911-134b-4c71-b60a-b8707484a73c
Set id: 60cb73cf-81b2-42eb-ad1a-4b2423b640e6
Version: 2
Effective Time: 20191226
 
SHISEIDO AMERICA INC.