SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I00- octinoxate and titanium dioxide powder SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I20- octinoxate and titanium dioxide powder SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I40- octinoxate and titanium dioxide powder SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I60- octinoxate and titanium dioxide powder SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) B20- octinoxate and titanium dioxide powder SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) B40- octinoxate and titanium dioxide powder SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) B60- octinoxate and titanium dioxide powder SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O20- octinoxate and titanium dioxide powder SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O40- octinoxate and titanium dioxide powder SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O60- octinoxate and titanium dioxide powder SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O80- octinoxate and titanium dioxide powder

SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) by

Drug Labeling and Warnings

SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) by is a Otc medication manufactured, distributed, or labeled by SHISEIDO CO., LTD., SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

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 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 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 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 (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 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 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 (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 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 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 80)

SHI SEIDO

O 80

The Makeup

Perfect Smoothing
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 16
sunscreen

10g NET WT. .35 OZ.

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2008

Labeler - SHISEIDO CO., LTD. (690536453)

Establishment
Name	Address	ID/FEI	Business Operations
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)