SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 1- ensulizole, octinoxate, and titanium dioxide cream SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 2- ensulizole, octinoxate, and titanium dioxide cream SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 3- ensulizole, octinoxate, and titanium dioxide cream

SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR by

Drug Labeling and Warnings

SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICA INC., Davlyn Industries Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:	Purpose
ENSULIZOLE 2.0%	Sunscreen
OCTINOXATE 7.4%	Sunscreen
TITANIUM DIOXIDE 7.2%	Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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:

• apply liberally 15 minutes before sun exposure
• reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive Ingredients

WATER, DIMETHICONE, SD ALCOHOL 40-B, PENTAERYTHRITYL TETRAETHYLHEXANOATE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, POLYMETHYL METHACRYLATE, GLYCERIN, DIPROPYLENE GLYCOL, DISTEARDIMONIUM HECTORITE, HYDROGENATED POLYDECENE, TRIMETHYLSILOXYSILICATE, SILICA, XYLITOL, PEG-6, PEG-32, PEG/PPG-14/7 DIMETHYL ETHER, THIOTAURINE, SAXIFRAGA SARMENTOSA EXTRACT, ARGININE HCl, ONONIS SPINOSA ROOT EXTRACT, SODIUM PCA, SOPHORA ANGUSTIFOLIA ROOT EXTRACT, PPG-17, ALUMINUM HYDROXIDE, AMINOMETHYL PROPANOL, ALUMINUM DISTEARATE, ISOSTEARIC ACID, STEARIC ACID, TRISODIUM EDTA, POLYMETHYLSILSESQUIOXANE, TALC, BUTYLENE GLYCOL, ALCOHOL, ALUMINA, POLYSILICONE-2, TRIETHOXYCAPRYLYLSILANE, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, BHT, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES, TITANIUM DIOXIDE,

Other information

• protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

SPL UNCLASSIFIED SECTION

SHISEIDO AMERICA INC.
NEW YORK, N.Y. 10022

SHISEIDO DIST.
NEW YORK PARIS MILANO

PRINCIPAL DISPLAY PANEL - 30mL Tube Carton

SHISEIDO

1

Anti-Aging
UV Care

43

Urban Environment
Tinted UV Protector

BROAD SPECTRUM
SPF 43

For Face
OIL-FREE

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

30mL NET WT. 1.1OZ.

PRINCIPAL DISPLAY PANEL - 30mL Tube Carton

SHISEIDO

2

Anti-Aging
UV Care

43

Urban Environment
Tinted UV Protector

BROAD SPECTRUM
SPF 43

For Face
OIL-FREE

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

30mL NET WT. 1.1OZ.

PRINCIPAL DISPLAY PANEL - 30mL Tube Carton

SHISEIDO

3

Anti-Aging
UV Care

43

Urban Environment
Tinted UV Protector

BROAD SPECTRUM
SPF 43

For Face
OIL-FREE

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

30mL NET WT. 1.1OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR   1
ensulizole, octinoxate, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-339
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	656 mg  in 32.79 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2426 mg  in 32.79 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2361 mg  in 32.79 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XYLITOL (UNII: VCQ006KQ1E)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
THIOTAURINE (UNII: NQZ2D7AO62)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
PPG-17 (UNII: OV0Q322E0U)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ISOSTEARIC ACID (UNII: X33R8U0062)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TALC (UNII: 7SEV7J4R1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-339-60	1 in 1 CARTON	03/01/2013
1		32.79 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2013

SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR   2
ensulizole, octinoxate, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-340
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	656 mg  in 32.79 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2426 mg  in 32.79 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2361 mg  in 32.79 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XYLITOL (UNII: VCQ006KQ1E)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
THIOTAURINE (UNII: NQZ2D7AO62)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
PPG-17 (UNII: OV0Q322E0U)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ISOSTEARIC ACID (UNII: X33R8U0062)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TALC (UNII: 7SEV7J4R1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-340-60	1 in 1 CARTON	03/01/2013
1		32.79 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2013

SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR   3
ensulizole, octinoxate, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-341
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	656 mg  in 32.79 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2426 mg  in 32.79 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2361 mg  in 32.79 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XYLITOL (UNII: VCQ006KQ1E)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
THIOTAURINE (UNII: NQZ2D7AO62)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
PPG-17 (UNII: OV0Q322E0U)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ISOSTEARIC ACID (UNII: X33R8U0062)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TALC (UNII: 7SEV7J4R1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-341-60	1 in 1 CARTON	03/01/2013
1		32.79 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2013

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(52686-339, 52686-340, 52686-341) , ANALYSIS(52686-339, 52686-340, 52686-341)