CLE DE PEAU BEAUTE CR COMPACT FOUNDATION BF20- titanium dioxide paste CLE DE PEAU BEAUTE CR COMPACT FOUNDATION I10- titanium

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)
Available from:
SHISEIDO CO., LTD.
INN (International Name):
Titanium dioxide
Composition:
Titanium dioxide 684 mg in 12 g
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - 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
Authorization status:
OTC monograph not final
Authorization number:
52685-372-30, 52685-373-30, 52685-374-30, 52685-375-30, 52685-376-30, 52685-377-30, 52685-378-30, 52685-379-30

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

SHISEIDO CO., LTD.

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.

----------

CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION

Drug Facts

Active ingredient

Titanium Dioxide 5.7%

Purpos e

Sunscreen

Us e

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

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

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.

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION BF20

titanium dioxide paste

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-372

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

6 8 4 mg in 12 g

Inactive Ingredients

Ingredient Name

Stre ng th

CYCLO METHICO NE (UNII: NMQ3479 9 4Z)

WATER (UNII: 0 59 QF0 KO0 R)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

PARAFFIN (UNII: I9 O0 E3H2ZE)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

PEG-10 DIMETHICO NE ( 6 0 0 CST) (UNII: 8 PR7V1SVM0 )

MICRO CRYSTALLINE WAX (UNII: XOF59 7Q3KY)

BARIUM SULFATE (UNII: 25BB7EKE2E)

MICA (UNII: V8 A1AW0 8 8 0 )

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

.ALPHA.-CELLULO SE (UNII: I355QGZ19 A)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

DISTEARYLDIMO NIUM CHLO RIDE (UNII: OM9 573ZX3X)

PALMITIC ACID (UNII: 2V16 EO9 5H1)

CANDELILLA WAX (UNII: WL0 328 HX19 )

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1)

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

GLYCERIN (UNII: PDC6 A3C0 OX)

STANNIC O XIDE (UNII: KM7N50 LOS6 )

RO SA RO XBURGHII FRUIT (UNII: CVT1AA8 7FF)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

BUPLEURUM FALCATUM RO O T (UNII: X0 4E310 LUY)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-372-30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part352

0 9 /0 1/20 10

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION I10

titanium dioxide paste

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-373

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

6 8 4 mg in 12 g

Inactive Ingredients

Ingredient Name

Stre ng th

CYCLO METHICO NE (UNII: NMQ3479 9 4Z)

WATER (UNII: 0 59 QF0 KO0 R)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

PARAFFIN (UNII: I9 O0 E3H2ZE)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

PEG-10 DIMETHICO NE ( 6 0 0 CST) (UNII: 8 PR7V1SVM0 )

MICRO CRYSTALLINE WAX (UNII: XOF59 7Q3KY)

BARIUM SULFATE (UNII: 25BB7EKE2E)

MICA (UNII: V8 A1AW0 8 8 0 )

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

.ALPHA.-CELLULO SE (UNII: I355QGZ19 A)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

DISTEARYLDIMO NIUM CHLO RIDE (UNII: OM9 573ZX3X)

PALMITIC ACID (UNII: 2V16 EO9 5H1)

CANDELILLA WAX (UNII: WL0 328 HX19 )

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1)

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

GLYCERIN (UNII: PDC6 A3C0 OX)

STANNIC O XIDE (UNII: KM7N50 LOS6 )

RO SA RO XBURGHII FRUIT (UNII: CVT1AA8 7FF)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

BUPLEURUM FALCATUM RO O T (UNII: X0 4E310 LUY)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-373-30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part352

0 9 /0 1/20 10

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION O10

titanium dioxide paste

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-374

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

6 8 4 mg in 12 g

Inactive Ingredients

Ingredient Name

Stre ng th

CYCLO METHICO NE (UNII: NMQ3479 9 4Z)

WATER (UNII: 0 59 QF0 KO0 R)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

PARAFFIN (UNII: I9 O0 E3H2ZE)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

PEG-10 DIMETHICO NE ( 6 0 0 CST) (UNII: 8 PR7V1SVM0 )

MICRO CRYSTALLINE WAX (UNII: XOF59 7Q3KY)

BARIUM SULFATE (UNII: 25BB7EKE2E)

MICA (UNII: V8 A1AW0 8 8 0 )

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

.ALPHA.-CELLULO SE (UNII: I355QGZ19 A)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

DISTEARYLDIMO NIUM CHLO RIDE (UNII: OM9 573ZX3X)

PALMITIC ACID (UNII: 2V16 EO9 5H1)

CANDELILLA WAX (UNII: WL0 328 HX19 )

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1)

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

GLYCERIN (UNII: PDC6 A3C0 OX)

STANNIC O XIDE (UNII: KM7N50 LOS6 )

RO SA RO XBURGHII FRUIT (UNII: CVT1AA8 7FF)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

BUPLEURUM FALCATUM RO O T (UNII: X0 4E310 LUY)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-374-30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part352

0 9 /0 1/20 10

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION O20

titanium dioxide paste

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-375

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

6 8 4 mg in 12 g

Inactive Ingredients

Ingredient Name

Stre ng th

CYCLO METHICO NE (UNII: NMQ3479 9 4Z)

WATER (UNII: 0 59 QF0 KO0 R)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

PARAFFIN (UNII: I9 O0 E3H2ZE)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

PEG-10 DIMETHICO NE ( 6 0 0 CST) (UNII: 8 PR7V1SVM0 )

MICRO CRYSTALLINE WAX (UNII: XOF59 7Q3KY)

BARIUM SULFATE (UNII: 25BB7EKE2E)

MICA (UNII: V8 A1AW0 8 8 0 )

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

.ALPHA.-CELLULO SE (UNII: I355QGZ19 A)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

DISTEARYLDIMO NIUM CHLO RIDE (UNII: OM9 573ZX3X)

PALMITIC ACID (UNII: 2V16 EO9 5H1)

CANDELILLA WAX (UNII: WL0 328 HX19 )

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1)

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

GLYCERIN (UNII: PDC6 A3C0 OX)

STANNIC O XIDE (UNII: KM7N50 LOS6 )

RO SA RO XBURGHII FRUIT (UNII: CVT1AA8 7FF)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

BUPLEURUM FALCATUM RO O T (UNII: X0 4E310 LUY)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-375-30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part352

0 9 /0 1/20 10

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION O30

titanium dioxide paste

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-376

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

6 8 4 mg in 12 g

Inactive Ingredients

Ingredient Name

Stre ng th

CYCLO METHICO NE (UNII: NMQ3479 9 4Z)

WATER (UNII: 0 59 QF0 KO0 R)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

PARAFFIN (UNII: I9 O0 E3H2ZE)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

PEG-10 DIMETHICO NE ( 6 0 0 CST) (UNII: 8 PR7V1SVM0 )

MICRO CRYSTALLINE WAX (UNII: XOF59 7Q3KY)

BARIUM SULFATE (UNII: 25BB7EKE2E)

MICA (UNII: V8 A1AW0 8 8 0 )

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

.ALPHA.-CELLULO SE (UNII: I355QGZ19 A)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

DISTEARYLDIMO NIUM CHLO RIDE (UNII: OM9 573ZX3X)

PALMITIC ACID (UNII: 2V16 EO9 5H1)

CANDELILLA WAX (UNII: WL0 328 HX19 )

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1)

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

GLYCERIN (UNII: PDC6 A3C0 OX)

STANNIC O XIDE (UNII: KM7N50 LOS6 )

RO SA RO XBURGHII FRUIT (UNII: CVT1AA8 7FF)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

BUPLEURUM FALCATUM RO O T (UNII: X0 4E310 LUY)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-376 -30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part352

0 9 /0 1/20 10

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION B10

titanium dioxide paste

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-377

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

6 8 4 mg in 12 g

Inactive Ingredients

Ingredient Name

Stre ng th

CYCLO METHICO NE (UNII: NMQ3479 9 4Z)

WATER (UNII: 0 59 QF0 KO0 R)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

PARAFFIN (UNII: I9 O0 E3H2ZE)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

PEG-10 DIMETHICO NE ( 6 0 0 CST) (UNII: 8 PR7V1SVM0 )

MICRO CRYSTALLINE WAX (UNII: XOF59 7Q3KY)

BARIUM SULFATE (UNII: 25BB7EKE2E)

MICA (UNII: V8 A1AW0 8 8 0 )

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

.ALPHA.-CELLULO SE (UNII: I355QGZ19 A)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

DISTEARYLDIMO NIUM CHLO RIDE (UNII: OM9 573ZX3X)

PALMITIC ACID (UNII: 2V16 EO9 5H1)

CANDELILLA WAX (UNII: WL0 328 HX19 )

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1)

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

GLYCERIN (UNII: PDC6 A3C0 OX)

STANNIC O XIDE (UNII: KM7N50 LOS6 )

RO SA RO XBURGHII FRUIT (UNII: CVT1AA8 7FF)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

BUPLEURUM FALCATUM RO O T (UNII: X0 4E310 LUY)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-377-30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part352

0 9 /0 1/20 10

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION B20

titanium dioxide paste

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-378

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

6 8 4 mg in 12 g

Inactive Ingredients

Ingredient Name

Stre ng th

CYCLO METHICO NE (UNII: NMQ3479 9 4Z)

WATER (UNII: 0 59 QF0 KO0 R)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

PARAFFIN (UNII: I9 O0 E3H2ZE)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

PEG-10 DIMETHICO NE ( 6 0 0 CST) (UNII: 8 PR7V1SVM0 )

MICRO CRYSTALLINE WAX (UNII: XOF59 7Q3KY)

BARIUM SULFATE (UNII: 25BB7EKE2E)

MICA (UNII: V8 A1AW0 8 8 0 )

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

.ALPHA.-CELLULO SE (UNII: I355QGZ19 A)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

DISTEARYLDIMO NIUM CHLO RIDE (UNII: OM9 573ZX3X)

PALMITIC ACID (UNII: 2V16 EO9 5H1)

CANDELILLA WAX (UNII: WL0 328 HX19 )

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1)

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

GLYCERIN (UNII: PDC6 A3C0 OX)

STANNIC O XIDE (UNII: KM7N50 LOS6 )

RO SA RO XBURGHII FRUIT (UNII: CVT1AA8 7FF)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

BUPLEURUM FALCATUM RO O T (UNII: X0 4E310 LUY)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-378 -30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part352

0 9 /0 1/20 10

CLE DE PEAU BEAUTE CR COMPACT FOUNDATION B30

titanium dioxide paste

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-379

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

6 8 4 mg in 12 g

Inactive Ingredients

Ingredient Name

Stre ng th

CYCLO METHICO NE (UNII: NMQ3479 9 4Z)

WATER (UNII: 0 59 QF0 KO0 R)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

PARAFFIN (UNII: I9 O0 E3H2ZE)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

PEG-10 DIMETHICO NE ( 6 0 0 CST) (UNII: 8 PR7V1SVM0 )

MICRO CRYSTALLINE WAX (UNII: XOF59 7Q3KY)

BARIUM SULFATE (UNII: 25BB7EKE2E)

MICA (UNII: V8 A1AW0 8 8 0 )

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

.ALPHA.-CELLULO SE (UNII: I355QGZ19 A)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

DISTEARYLDIMO NIUM CHLO RIDE (UNII: OM9 573ZX3X)

SHISEIDO CO., LTD.

PALMITIC ACID (UNII: 2V16 EO9 5H1)

CANDELILLA WAX (UNII: WL0 328 HX19 )

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1)

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

GLYCERIN (UNII: PDC6 A3C0 OX)

STANNIC O XIDE (UNII: KM7N50 LOS6 )

RO SA RO XBURGHII FRUIT (UNII: CVT1AA8 7FF)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

BUPLEURUM FALCATUM RO O T (UNII: X0 4E310 LUY)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-379 -30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part352

0 9 /0 1/20 10

Labeler -

SHISEIDO CO., LT D. (690536453)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

SHISEIDO

CO., LTD.

6 9 558 9 38 2

MANUFACTURE(526 8 5-372, 526 8 5-373, 526 8 5-374, 526 8 5-375, 526 8 5-376 , 526 8 5-377, 526 8 5-

378 , 526 8 5-379 ) , ANALYSIS(526 8 5-372, 526 8 5-373, 526 8 5-374, 526 8 5-375, 526 8 5-376 , 526 8 5-

377, 526 8 5-378 , 526 8 5-379 )

Revised: 4/2012

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