SHISEIDO URBAN ENVIRONMENT UV PROTECTION- octinoxate, octocrylene, and zinc oxide cream 
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 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 - 50 mL Tube Carton

SHISEIDO
GINZA TOKYO

Urban Environment
UV Protection Cream

40

BROAD SPECTRUM
SPF 40

For Face/Body

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

50mL NET WT. 1.9 OZ.

Principal Display Panel - 50 mL Tube Carton
SHISEIDO URBAN ENVIRONMENT UV PROTECTION 
octinoxate, octocrylene, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-347
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 SPINOSA 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:58411-347-802.18 g in 1 POUCH; Type 0: Not a Combination Product10/01/2012
2NDC:58411-347-601 in 1 CARTON10/01/2012
254.6 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:58411-347-611 in 1 CARTON10/01/2012
37.64 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:58411-347-621 in 1 CARTON10/01/2012
416.38 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 AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132MANUFACTURE(58411-347) , ANALYSIS(58411-347)

Revised: 12/2019
Document Id: 6af27151-dfdd-41a4-81d0-0d493a2ed688
Set id: b98642c1-d17c-41d9-a21d-270deb3165af
Version: 2
Effective Time: 20191226
 
SHISEIDO AMERICAS CORPORATION