SHISEIDO URBAN ENVIRONMENT UV PROTECTION- octinoxate, octocrylene, and zinc oxide cream 
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.

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SHISEIDO URBAN ENVIRONMENT UV PROTECTION

CREAM

Drug Facts

ACTIVE INGREDIENTS:Purpose
OCTINOXATE 2.9%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
ZINC OXIDE 10.6%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, ISODODECANE, CYCLOMETHICONE, DIMETHICONE, BUTYLENE GLYCOL, SD ALCOHOL 40-B, POLYMETHYL METHACRYLATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, GLYCERIN, DISTEARDIMONIUM HECTORITE, XYLITOL, METHYL GLUCETH-10, PEG/PPG-14/7 DIMETHYL ETHER, THIOTAURINE, SCUTELLARIA BAICALENSIS ROOT EXTRACT, ARGININE HCl, ONONIS SPINOSA ROOT EXTRACT, ECTOIN, SODIUM PCA, HYDROGENATED POLYDECENE, HYDROGEN DIMETHICONE, ISOSTEARIC ACID, BENZOPHENONE-3, TRISODIUM EDTA, SILICA, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, ALUMINA, TRIETHOXYCAPRYLYLSILANE, BHT, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE,

Other information

Questions or comments?

Call toll free 1-800-906-7503

SHISEIDO DIST. NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL - 50mL Tube Carton

SHI SEIDO

Anti-Aging UV Care

40

Urban Enviroment
UV Protection Cream

BROAD SPECTRUM
SPF 40

For Face/Body

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

50mL NET WT. 1.9 OZ.

Principal Display Panel - 50mL Tube Carton
SHISEIDO URBAN ENVIRONMENT UV PROTECTION 
octinoxate, octocrylene, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-271
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1583 mg  in 54.6 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1638 mg  in 54.6 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5788 mg  in 54.6 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
METHYL GLUCETH-10 (UNII: N0MWT4C7WH)  
THIOTAURINE (UNII: NQZ2D7AO62)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)  
ONONIS CAMPESTRIS ROOT (UNII: FD2FMC53M1)  
ECTOINE (UNII: 7GXZ3858RY)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
OXYBENZONE (UNII: 95OOS7VE0Y)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-271-601 in 1 CARTON10/01/2012
154.6 g in 1 TUBE; 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. (782677132)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(52686-271) , analysis(52686-271)

Revised: 12/2018
Document Id: 7cf0654f-6a7c-53e2-e053-2a91aa0a32a7
Set id: fb4dfdf9-2ee4-42ed-8d95-07f7e1b24495
Version: 3
Effective Time: 20181213
 
SHISEIDO AMERICA INC.