SHISEIDO PERFECT HYDRATING BB MEDIUM: Package Insert and Label Information

SHISEIDO PERFECT HYDRATING BB MEDIUM- ensulizole, octinoxate and titanium dioxide cream
SHISEIDO PERFECT HYDRATING BB DARK- ensulizole, octinoxate and titanium dioxide cream
SHISEIDO PERFECT HYDRATING BB LIGHT- 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
• use a water resistant sunscreen if swimming or sweating
• reapply 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

PRINCIPAL DISPLAY PANEL — 30 mL Tube Carton — Medium

SHI SEIDO

MEDIUM

BB

Perfect
Hydrating
BB Cream

BROAD SPECTRUM
SPF 35

SUNSCREEN

30mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL — 30 mL Tube Carton — Dark

SHI SEIDO

DARK

BB

Perfect
Hydrating
BB Cream

BROAD SPECTRUM
SPF 35

SUNSCREEN

30mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL — 30 mL Tube Carton — Light

SHI SEIDO

LIGHT

BB

Perfect
Hydrating
BB Cream

BROAD SPECTRUM
SPF 35

SUNSCREEN

30mL NET WT. 1.1 OZ.

SHISEIDO PERFECT HYDRATING BB MEDIUM ensulizole, octinoxate, and titanium dioxide cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-342 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:52686-342-60 1 TUBE in 1 CARTON contains a TUBE 1 32.79 g in 1 TUBE This package is contained within the CARTON (52686-342-60)

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

SHISEIDO PERFECT HYDRATING BB DARK ensulizole, octinoxate, and titanium dioxide cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-343 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:52686-343-60 1 TUBE in 1 CARTON contains a TUBE 1 32.79 g in 1 TUBE This package is contained within the CARTON (52686-343-60)

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

SHISEIDO PERFECT HYDRATING BB LIGHT ensulizole, octinoxate, and titanium dioxide cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-344 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 PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE GLYCERIN DIPROPYLENE GLYCOL DISTEARDIMONIUM HECTORITE 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:52686-344-60 1 TUBE in 1 CARTON contains a TUBE 1 32.79 g in 1 TUBE This package is contained within the CARTON (52686-344-60)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 04/01/2014

Labeler — SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE (52686-342), MANUFACTURE (52686-343), MANUFACTURE (52686-344), ANALYSIS (52686-342), ANALYSIS (52686-343), ANALYSIS (52686-344)

Establishment
Name	Address	ID/FEI	Operations
Davlyn Industries Inc		624436254	MANUFACTURE (52686-342), MANUFACTURE (52686-343), MANUFACTURE (52686-344)

Revised: 11/2013 SHISEIDO AMERICA INC.