Drug Facts

Active ingredients	Purpose
OCTINOXATE 1.4%	Sunscreen
TITANIUM DIOXIDE 2.5%	Sunscreen

Use

helps prevent sunburn

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

BARIUM SULFATE • TALC • TITANIUM DIOXIDE • MICA • VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER • SYNTHETIC FLUORPHLOGOPITE • IRON OXIDES • ZINC MYRISTATE • DIMETHICONE • BORON NITRIDE • DIISOSTEARYL MALATE • PETROLATUM • SQUALANE • ZINC OXIDE • SORBITAN SESQUIISOSTEARATE • POLYSILICONE-2 • ALUMINUM HYDROXIDE • ALUMINUM DISTEARATE • ETHYLHEXYLGLYCERIN • PEG/PPG-36/41 DIMETHYL ETHER • ALCOHOL • WATER • TOCOPHEROL • POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE • FRAGRANCE • PHENOXYETHANOL • ALUMINA • BHT • ROYAL JELLY EXTRACT

Other information

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

Questions or comments?

Call toll free 1-800-906-7503

Manufactured by
SHISEIDO CO., LTD. 7-5-5 GINZA TOKYO

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (I 00)

SHI SEIDO

I 00

The Makeup

Perfect Smoothing
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 16
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10g Tray Carton (I 00)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (I 20)

SHI SEIDO

I 20

The Makeup

Perfect Smoothing
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 16
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10g Tray Carton (I 20)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (I 40)

SHI SEIDO

I 40

The Makeup

Perfect Smoothing
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 16
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10g Tray Carton (I 40)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (I 60)

SHI SEIDO

I 60

The Makeup

Perfect Smoothing
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 16
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10g Tray Carton (I 60)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (B 20)

SHI SEIDO

B 20

The Makeup

Perfect Smoothing
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 16
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10g Tray Carton (B 20)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (B 40)

SHI SEIDO

B 40

The Makeup

Perfect Smoothing
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 16
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10g Tray Carton (B 40)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (B 60)

SHI SEIDO

B 60

The Makeup

Perfect Smoothing
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 16
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10g Tray Carton (B 60)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (O 20)

SHI SEIDO

O 20

The Makeup

Perfect Smoothing
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 16
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10g Tray Carton (O 20)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (O 40)

SHI SEIDO

O 40

The Makeup

Perfect Smoothing
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 16
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10g Tray Carton (O 40)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (O 60)

SHI SEIDO

O 60

The Makeup

Perfect Smoothing
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 16
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10g Tray Carton (O 60)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (O 80)

SHI SEIDO

O 80

The Makeup

Perfect Smoothing
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 16
sunscreen

10g NET WT. .35 OZ.

Principal Display Panel - 10g Tray Carton (O 80)

SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I00
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-433
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	140 mg in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	250 mg in 10 g

Ingredient Name	Strength
Inactive Ingredients
BARIUM SULFATE (UNII: 25BB7EKE2E)
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC MYRISTATE (UNII: K09A9E2GGO)
DIMETHICONE (UNII: 92RU3N3Y1O)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PETROLATUM (UNII: 4T6H12BN9U)
SQUALANE (UNII: GW89575KF9)
ZINC OXIDE (UNII: SOI2LOH54Z)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROYAL JELLY (UNII: L497I37F0C)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52685-433-30	1 in 1 CARTON	09/01/2008
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/01/2008

SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-434
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	140 mg in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	250 mg in 10 g

Ingredient Name	Strength
Inactive Ingredients
BARIUM SULFATE (UNII: 25BB7EKE2E)
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC MYRISTATE (UNII: K09A9E2GGO)
DIMETHICONE (UNII: 92RU3N3Y1O)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PETROLATUM (UNII: 4T6H12BN9U)
SQUALANE (UNII: GW89575KF9)
ZINC OXIDE (UNII: SOI2LOH54Z)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROYAL JELLY (UNII: L497I37F0C)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52685-434-30	1 in 1 CARTON	09/01/2008
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/01/2008

SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I40
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-435
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	140 mg in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	250 mg in 10 g

Ingredient Name	Strength
Inactive Ingredients
BARIUM SULFATE (UNII: 25BB7EKE2E)
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC MYRISTATE (UNII: K09A9E2GGO)
DIMETHICONE (UNII: 92RU3N3Y1O)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PETROLATUM (UNII: 4T6H12BN9U)
SQUALANE (UNII: GW89575KF9)
ZINC OXIDE (UNII: SOI2LOH54Z)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROYAL JELLY (UNII: L497I37F0C)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52685-435-30	1 in 1 CARTON	09/01/2008
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/01/2008

SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I60
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-436
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	140 mg in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	250 mg in 10 g

Ingredient Name	Strength
Inactive Ingredients
BARIUM SULFATE (UNII: 25BB7EKE2E)
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC MYRISTATE (UNII: K09A9E2GGO)
DIMETHICONE (UNII: 92RU3N3Y1O)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PETROLATUM (UNII: 4T6H12BN9U)
SQUALANE (UNII: GW89575KF9)
ZINC OXIDE (UNII: SOI2LOH54Z)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROYAL JELLY (UNII: L497I37F0C)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52685-436-30	1 in 1 CARTON	09/01/2008
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/01/2008

SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) B20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-437
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	140 mg in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	250 mg in 10 g

Ingredient Name	Strength
Inactive Ingredients
BARIUM SULFATE (UNII: 25BB7EKE2E)
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC MYRISTATE (UNII: K09A9E2GGO)
DIMETHICONE (UNII: 92RU3N3Y1O)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PETROLATUM (UNII: 4T6H12BN9U)
SQUALANE (UNII: GW89575KF9)
ZINC OXIDE (UNII: SOI2LOH54Z)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROYAL JELLY (UNII: L497I37F0C)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52685-437-30	1 in 1 CARTON	09/01/2008
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/01/2008

SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) B40
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-438
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	140 mg in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	250 mg in 10 g

Ingredient Name	Strength
Inactive Ingredients
BARIUM SULFATE (UNII: 25BB7EKE2E)
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC MYRISTATE (UNII: K09A9E2GGO)
DIMETHICONE (UNII: 92RU3N3Y1O)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PETROLATUM (UNII: 4T6H12BN9U)
SQUALANE (UNII: GW89575KF9)
ZINC OXIDE (UNII: SOI2LOH54Z)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROYAL JELLY (UNII: L497I37F0C)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52685-438-30	1 in 1 CARTON	09/01/2008
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/01/2008

SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) B60
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-439
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	140 mg in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	250 mg in 10 g

Ingredient Name	Strength
Inactive Ingredients
BARIUM SULFATE (UNII: 25BB7EKE2E)
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC MYRISTATE (UNII: K09A9E2GGO)
DIMETHICONE (UNII: 92RU3N3Y1O)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PETROLATUM (UNII: 4T6H12BN9U)
SQUALANE (UNII: GW89575KF9)
ZINC OXIDE (UNII: SOI2LOH54Z)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROYAL JELLY (UNII: L497I37F0C)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52685-439-30	1 in 1 CARTON	09/01/2008
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/01/2008

SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-440
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	140 mg in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	250 mg in 10 g

Ingredient Name	Strength
Inactive Ingredients
BARIUM SULFATE (UNII: 25BB7EKE2E)
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC MYRISTATE (UNII: K09A9E2GGO)
DIMETHICONE (UNII: 92RU3N3Y1O)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PETROLATUM (UNII: 4T6H12BN9U)
SQUALANE (UNII: GW89575KF9)
ZINC OXIDE (UNII: SOI2LOH54Z)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROYAL JELLY (UNII: L497I37F0C)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52685-440-30	1 in 1 CARTON	09/01/2008
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/01/2008

SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O40
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-441
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	140 mg in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	250 mg in 10 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
SQUALANE (UNII: GW89575KF9)
ZINC OXIDE (UNII: SOI2LOH54Z)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROYAL JELLY (UNII: L497I37F0C)
BARIUM SULFATE (UNII: 25BB7EKE2E)
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC MYRISTATE (UNII: K09A9E2GGO)
DIMETHICONE (UNII: 92RU3N3Y1O)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52685-441-30	1 in 1 CARTON	09/01/2008
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/01/2008

SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O60
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-442
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	140 mg in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	250 mg in 10 g

Ingredient Name	Strength
Inactive Ingredients
BARIUM SULFATE (UNII: 25BB7EKE2E)
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC MYRISTATE (UNII: K09A9E2GGO)
DIMETHICONE (UNII: 92RU3N3Y1O)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PETROLATUM (UNII: 4T6H12BN9U)
SQUALANE (UNII: GW89575KF9)
ZINC OXIDE (UNII: SOI2LOH54Z)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROYAL JELLY (UNII: L497I37F0C)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52685-442-30	1 in 1 CARTON	09/01/2008
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/01/2008

SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O80
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-443
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	140 mg in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	250 mg in 10 g

Ingredient Name	Strength
Inactive Ingredients
BARIUM SULFATE (UNII: 25BB7EKE2E)
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC MYRISTATE (UNII: K09A9E2GGO)
DIMETHICONE (UNII: 92RU3N3Y1O)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PETROLATUM (UNII: 4T6H12BN9U)
SQUALANE (UNII: GW89575KF9)
ZINC OXIDE (UNII: SOI2LOH54Z)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROYAL JELLY (UNII: L497I37F0C)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52685-443-30	1 in 1 CARTON	09/01/2008
1		10 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/01/2008

Labeler - SHISEIDO CO., LTD. (690536453)

Name	Address	ID/FEI	Business Operations
Establishment
SHISEIDO AMERICA INC.		782677132	manufacture(52685-433, 52685-434, 52685-435, 52685-436, 52685-437, 52685-438, 52685-439, 52685-440, 52685-441, 52685-442, 52685-443) , analysis(52685-433, 52685-434, 52685-435, 52685-436, 52685-437, 52685-438, 52685-439, 52685-440, 52685-441, 52685-442, 52685-443)

PERFECT SMOOTHING COMPACT FOUNDATION (Refill)

Use

Warnings

Directions

Inactive Ingredients

Other information

Questions or comments?

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (I 00)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (I 20)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (I 40)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (I 60)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (B 20)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (B 40)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (B 60)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (O 20)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (O 40)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (O 60)

PRINCIPAL DISPLAY PANEL - 10g Tray Carton (O 80)