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%

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

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 - BF20

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 - I10

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 - O10

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 - O20

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 - O30

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 - B10

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 - B20

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.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - B30
CLE DE PEAU BEAUTE CR COMPACT FOUNDATION   BF20
titanium dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-372
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide684 mg  in 12 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-372-301 in 1 CARTON09/01/201012/31/2020
112 g in 1 TRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/201012/31/2020
CLE DE PEAU BEAUTE CR COMPACT FOUNDATION   I10
titanium dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-373
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide684 mg  in 12 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-373-301 in 1 CARTON09/01/201012/31/2020
112 g in 1 TRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/201012/31/2020
CLE DE PEAU BEAUTE CR COMPACT FOUNDATION   O10
titanium dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-374
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide684 mg  in 12 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-374-301 in 1 CARTON09/01/201012/31/2020
112 g in 1 TRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/201012/31/2020
CLE DE PEAU BEAUTE CR COMPACT FOUNDATION   O20
titanium dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-375
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide684 mg  in 12 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-375-301 in 1 CARTON09/01/201012/31/2020
112 g in 1 TRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/201012/31/2020
CLE DE PEAU BEAUTE CR COMPACT FOUNDATION   O30
titanium dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-376
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide684 mg  in 12 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-376-301 in 1 CARTON09/01/201012/31/2020
112 g in 1 TRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/201012/31/2020
CLE DE PEAU BEAUTE CR COMPACT FOUNDATION   B10
titanium dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-377
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide684 mg  in 12 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-377-301 in 1 CARTON09/01/201012/31/2020
112 g in 1 TRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/201012/31/2020
CLE DE PEAU BEAUTE CR COMPACT FOUNDATION   B20
titanium dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-378
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide684 mg  in 12 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-378-301 in 1 CARTON09/01/201012/31/2020
112 g in 1 TRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/201012/31/2020
CLE DE PEAU BEAUTE CR COMPACT FOUNDATION   B30
titanium dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-379
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide684 mg  in 12 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-379-301 in 1 CARTON09/01/201012/31/2020
112 g in 1 TRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/201012/31/2020
Labeler - SHISEIDO CO., LTD. (690536453)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO CO., LTD.695589382MANUFACTURE(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)

Revised: 9/2023
 
SHISEIDO CO., LTD.