CLE DE PEAU BEAUTE CR COMPACT FOUNDATION BF20- titanium dioxide paste CLE DE PEAU BEAUTE CR COMPACT FOUNDATION I10- titanium dioxide paste CLE DE PEAU BEAUTE CR COMPACT FOUNDATION O10- titanium dioxide paste CLE DE PEAU BEAUTE CR COMPACT FOUNDATION O20- titanium dioxide paste CLE DE PEAU BEAUTE CR COMPACT FOUNDATION O30- titanium dioxide paste CLE DE PEAU BEAUTE CR COMPACT FOUNDATION B10- titanium dioxide paste CLE DE PEAU BEAUTE CR COMPACT FOUNDATION B20- titanium dioxide paste CLE DE PEAU BEAUTE CR COMPACT FOUNDATION B30- titanium dioxide paste

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION by is a Otc medication manufactured, distributed, or labeled by SHISEIDO CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Titanium Dioxide 5.7%

Purpose

Sunscreen

Use

• 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

CYCLOMETHICONE, WATER, SYNTHETIC FLUORPHLOGOPITE, DIPROPYLENE GLYCOL, PARAFFIN, SORBITAN SESQUIISOSTEARATE, DIPHENYLSILOXY PHENYL TRIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG-10 DIMETHICONE, MICROCRYSTALLINE WAX, BARIUM SULFATE, EUPHORBIA CERIFERA (CANDELILLA) WAX, TOCOPHERYL ACETATE, ROSA ROXBURGHII FRUIT EXTRACT, SODIUM ACETYLATED HYALURONATE, CAMELLIA SINENSIS LEAF EXTRACT, BUPLEURUM FALCATUM ROOT EXTRACT, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, POLYSILICONE-2, CELLULOSE, DIMETHICONE, ALUMINA, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, PALMITIC ACID, HYDROGEN DIMETHICONE, BUTYLENE GLYCOL, TOCOPHEROL, ISOPROPYL ALCOHOL, TRIETHOXYCAPRYLYLSILANE, ALCOHOL, GLYCERIN, TIN OXIDE, PHENOXYETHANOL, FRAGRANCE, TITANIMU DIOXIDE IRON OXIDES, MICA

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 - 12 g Tray Carton - BF20

clé de peau
BEAUTÉ

cream compact foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - I10

clé de peau
BEAUTÉ

cream compact foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - O10

clé de peau
BEAUTÉ

cream compact foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - O20

clé de peau
BEAUTÉ

cream compact foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - O30

clé de peau
BEAUTÉ

cream compact foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - B10

clé de peau
BEAUTÉ

cream compact foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - B20

clé de peau
BEAUTÉ

cream compact foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - B30

clé de peau
BEAUTÉ

cream compact foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION   BF20
titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-372
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	684 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PARAFFIN (UNII: I9O0E3H2ZE)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-CELLULOSE (UNII: I355QGZ19A)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PALMITIC ACID (UNII: 2V16EO95H1)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
STANNIC OXIDE (UNII: KM7N50LOS6)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-372-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2010

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION   I10
titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-373
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	684 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PARAFFIN (UNII: I9O0E3H2ZE)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-CELLULOSE (UNII: I355QGZ19A)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PALMITIC ACID (UNII: 2V16EO95H1)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
STANNIC OXIDE (UNII: KM7N50LOS6)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-373-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2010

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION   O10
titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-374
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	684 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PARAFFIN (UNII: I9O0E3H2ZE)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-CELLULOSE (UNII: I355QGZ19A)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PALMITIC ACID (UNII: 2V16EO95H1)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
STANNIC OXIDE (UNII: KM7N50LOS6)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-374-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2010

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION   O20
titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-375
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	684 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PARAFFIN (UNII: I9O0E3H2ZE)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-CELLULOSE (UNII: I355QGZ19A)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PALMITIC ACID (UNII: 2V16EO95H1)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
STANNIC OXIDE (UNII: KM7N50LOS6)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-375-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2010

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION   O30
titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-376
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	684 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PARAFFIN (UNII: I9O0E3H2ZE)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-CELLULOSE (UNII: I355QGZ19A)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PALMITIC ACID (UNII: 2V16EO95H1)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
STANNIC OXIDE (UNII: KM7N50LOS6)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-376-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2010

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION   B10
titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-377
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	684 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PARAFFIN (UNII: I9O0E3H2ZE)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-CELLULOSE (UNII: I355QGZ19A)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PALMITIC ACID (UNII: 2V16EO95H1)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
STANNIC OXIDE (UNII: KM7N50LOS6)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-377-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2010

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION   B20
titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-378
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	684 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PARAFFIN (UNII: I9O0E3H2ZE)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-CELLULOSE (UNII: I355QGZ19A)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PALMITIC ACID (UNII: 2V16EO95H1)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
STANNIC OXIDE (UNII: KM7N50LOS6)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-378-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2010

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION   B30
titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-379
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	684 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PARAFFIN (UNII: I9O0E3H2ZE)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-CELLULOSE (UNII: I355QGZ19A)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PALMITIC ACID (UNII: 2V16EO95H1)
CANDELILLA WAX (UNII: WL0328HX19)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
STANNIC OXIDE (UNII: KM7N50LOS6)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-379-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2010

Labeler - SHISEIDO CO., LTD. (690536453)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO CO., LTD.		695589382	MANUFACTURE(52685-372, 52685-373, 52685-374, 52685-375, 52685-376, 52685-377, 52685-378, 52685-379) , ANALYSIS(52685-372, 52685-373, 52685-374, 52685-375, 52685-376, 52685-377, 52685-378, 52685-379)