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

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

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.

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.