SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 1: Package Insert and Label Information

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 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.

Drug Facts

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

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

SHISEIDO DIST.
NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL — 30mL Tube Carton

SHI SEIDO

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
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30mL Tube Carton

SHI SEIDO

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
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30mL Tube Carton

SHI SEIDO

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.

PRINCIPAL DISPLAY PANEL -- 30mL Tube Carton
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 656 mg in 32.79 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 2426 mg in 32.79 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2361 mg in 32.79 g
Inactive Ingredients
Ingredient Name Strength
WATER
DIMETHICONE
PENTAERYTHRITYL TETRAETHYLHEXANOATE
GLYCERIN
DIPROPYLENE GLYCOL
HYDROGENATED POLYDECENE (550 MW)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
SILICON DIOXIDE
XYLITOL
POLYETHYLENE GLYCOL 300
POLYETHYLENE GLYCOL 1500
PEG/PPG-14/7 DIMETHYL ETHER
THIOTAURINE
SAXIFRAGA STOLONIFERA LEAF
ARGININE HYDROCHLORIDE
ONONIS SPINOSA ROOT
SODIUM PYRROLIDONE CARBOXYLATE
SOPHORA FLAVESCENS ROOT
PPG-17
ALUMINUM HYDROXIDE
AMINOMETHYLPROPANOL
ALUMINUM DISTEARATE
ISOSTEARIC ACID
STEARIC ACID
EDETATE TRISODIUM
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
TALC
BUTYLENE GLYCOL
ALCOHOL
ALUMINUM OXIDE
TRIETHOXYCAPRYLYLSILANE
BUTYLATED HYDROXYTOLUENE
SYZYGIUM JAMBOS LEAF
.ALPHA.-TOCOPHEROL
PHENOXYETHANOL
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52686-339-60 1 TUBE in 1 CARTON contains a TUBE
1 32.79 g in 1 TUBE This package is contained within the CARTON (52686-339-60)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 656 mg in 32.79 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 2426 mg in 32.79 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2361 mg in 32.79 g
Inactive Ingredients
Ingredient Name Strength
WATER
DIMETHICONE
PENTAERYTHRITYL TETRAETHYLHEXANOATE
GLYCERIN
DIPROPYLENE GLYCOL
HYDROGENATED POLYDECENE (550 MW)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
SILICON DIOXIDE
XYLITOL
POLYETHYLENE GLYCOL 300
POLYETHYLENE GLYCOL 1500
PEG/PPG-14/7 DIMETHYL ETHER
THIOTAURINE
SAXIFRAGA STOLONIFERA LEAF
ARGININE HYDROCHLORIDE
ONONIS SPINOSA ROOT
SODIUM PYRROLIDONE CARBOXYLATE
SOPHORA FLAVESCENS ROOT
PPG-17
ALUMINUM HYDROXIDE
AMINOMETHYLPROPANOL
ALUMINUM DISTEARATE
ISOSTEARIC ACID
STEARIC ACID
EDETATE TRISODIUM
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
TALC
BUTYLENE GLYCOL
ALCOHOL
ALUMINUM OXIDE
TRIETHOXYCAPRYLYLSILANE
BUTYLATED HYDROXYTOLUENE
SYZYGIUM JAMBOS LEAF
.ALPHA.-TOCOPHEROL
PHENOXYETHANOL
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52686-340-60 1 TUBE in 1 CARTON contains a TUBE
1 32.79 g in 1 TUBE This package is contained within the CARTON (52686-340-60)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 656 mg in 32.79 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 2426 mg in 32.79 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2361 mg in 32.79 g
Inactive Ingredients
Ingredient Name Strength
WATER
DIMETHICONE
PENTAERYTHRITYL TETRAETHYLHEXANOATE
GLYCERIN
DIPROPYLENE GLYCOL
HYDROGENATED POLYDECENE (550 MW)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
SILICON DIOXIDE
XYLITOL
POLYETHYLENE GLYCOL 300
POLYETHYLENE GLYCOL 1500
PEG/PPG-14/7 DIMETHYL ETHER
THIOTAURINE
SAXIFRAGA STOLONIFERA LEAF
ARGININE HYDROCHLORIDE
ONONIS SPINOSA ROOT
SODIUM PYRROLIDONE CARBOXYLATE
SOPHORA FLAVESCENS ROOT
PPG-17
ALUMINUM HYDROXIDE
AMINOMETHYLPROPANOL
ALUMINUM DISTEARATE
ISOSTEARIC ACID
STEARIC ACID
EDETATE TRISODIUM
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
TALC
BUTYLENE GLYCOL
ALCOHOL
ALUMINUM OXIDE
TRIETHOXYCAPRYLYLSILANE
BUTYLATED HYDROXYTOLUENE
SYZYGIUM JAMBOS LEAF
.ALPHA.-TOCOPHEROL
PHENOXYETHANOL
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52686-341-60 1 TUBE in 1 CARTON contains a TUBE
1 32.79 g in 1 TUBE This package is contained within the CARTON (52686-341-60)
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 Operations
SHISEIDO AMERICA INC. 782677132 MANUFACTURE (52686-339), MANUFACTURE (52686-340), MANUFACTURE (52686-341), ANALYSIS (52686-339), ANALYSIS (52686-340), ANALYSIS (52686-341)

Revised: 12/2019 SHISEIDO AMERICA INC.

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