CLE DE PEAU BEAUTE SILKY FOUNDATION I  BF20- octinoxate and titanium dioxide cream 
CLE DE PEAU BEAUTE SILKY FOUNDATION I  I10- octinoxate and titanium dioxide cream 
CLE DE PEAU BEAUTE SILKY FOUNDATION I  O10- octinoxate and titanium dioxide cream 
CLE DE PEAU BEAUTE SILKY FOUNDATION I  O20- octinoxate and titanium dioxide cream 
CLE DE PEAU BEAUTE SILKY FOUNDATION I  O30- octinoxate and titanium dioxide cream 
CLE DE PEAU BEAUTE SILKY FOUNDATION I  B10- octinoxate and titanium dioxide cream 
CLE DE PEAU BEAUTE SILKY FOUNDATION I  B20- octinoxate and titanium dioxide cream 
CLE DE PEAU BEAUTE SILKY FOUNDATION I  B30- octinoxate and titanium dioxide cream 
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 SILKY CR FOUNDATION L

Drug Facts

Active ingredientsPurpose
OCTINOXATE1.9%Sunscreen
TITANUIM DIOXIDE4.1%Sunscreen

Uses

  • 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

WATER • DIMETHICONE • GLYCERIN • DIPHENYLSILOXY PHENYL TRIMETHICONE • BUTYLENE GLYCOL • DIETHYLHEXYL SUCCINATE • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • PEG-10 DIMETHICONE • DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER • DISTEARDIMONIUM HECTORITE • CYCLOMETHICONE • POLYGLYCERYL-2 DIISOSTEARATE • BARIUM SULFATE • NYLON-12 • DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE • POLYMETHYL METHACRYLATE • SODIUM HYALURONATE • SODIUM ACETYLATED HYALURONATE • ROSA ROXBURGHII FRUIT EXTRACT • ORIGANUM MAJORANA LEAF EXTRACT • LILIUM CANDIDUM BULB EXTRACT • ALUMINUM HYDROXIDE • ALUMINUM DISTEARATE • ALUMINA • TRISODIUM EDTA • TRIETHOXYCAPRYLYLSILANE • VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER • POLYSILICONE-2 • BHT • SYNTHETIC FLUORPHLOGOPITE • TOCOPHEROL • TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE • PHENOXYETHANOL • SODIUM DEHYDROACETATE • FRAGRANCE • TITANIUM 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 - 25 mL Tube Carton - BF20

clé de peau
BEAUTÉ

silky cream foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

25mL NET WT. .91 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - BF20

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - I10

clé de peau
BEAUTÉ

silky cream foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

25mL NET WT. .91 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - I10

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - O10

clé de peau
BEAUTÉ

silky cream foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

25mL NET WT. .91 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - O10

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - O20

clé de peau
BEAUTÉ

silky cream foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

25mL NET WT. .91 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - O20

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - O30

clé de peau
BEAUTÉ

silky cream foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

25mL NET WT. .91 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - O30

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - B10

clé de peau
BEAUTÉ

silky cream foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

25mL NET WT. .91 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - B10

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - B20

clé de peau
BEAUTÉ

silky cream foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

25mL NET WT. .91 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - B20

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - B30

clé de peau
BEAUTÉ

silky cream foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

25mL NET WT. .91 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - B30
CLE DE PEAU BEAUTE SILKY FOUNDATION I   BF20
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-356
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.53865 g  in 28.35 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide1.16235 g  in 28.35 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
NYLON-12 (UNII: 446U8J075B)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MICA (UNII: V8A1AW0880)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ORIGANUM MAJORANA WHOLE (UNII: R40XM3HU5X)  
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-356-601 in 1 CARTON09/01/201112/31/2020
128.35 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/201112/31/2020
CLE DE PEAU BEAUTE SILKY FOUNDATION I   I10
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-357
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.53865 g  in 28.35 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide1.16235 g  in 28.35 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
NYLON-12 (UNII: 446U8J075B)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MICA (UNII: V8A1AW0880)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ORIGANUM MAJORANA WHOLE (UNII: R40XM3HU5X)  
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-357-601 in 1 CARTON09/01/201112/31/2020
128.35 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/201112/31/2020
CLE DE PEAU BEAUTE SILKY FOUNDATION I   O10
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-358
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.53865 g  in 28.35 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide1.16235 g  in 28.35 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
NYLON-12 (UNII: 446U8J075B)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MICA (UNII: V8A1AW0880)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ORIGANUM MAJORANA WHOLE (UNII: R40XM3HU5X)  
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-358-601 in 1 CARTON09/01/201112/31/2020
128.35 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/201112/31/2020
CLE DE PEAU BEAUTE SILKY FOUNDATION I   O20
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-359
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.53865 g  in 28.35 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide1.16235 g  in 28.35 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
NYLON-12 (UNII: 446U8J075B)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MICA (UNII: V8A1AW0880)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ORIGANUM MAJORANA WHOLE (UNII: R40XM3HU5X)  
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-359-601 in 1 CARTON09/01/201112/31/2020
128.35 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/201112/31/2020
CLE DE PEAU BEAUTE SILKY FOUNDATION I   O30
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-360
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.53865 g  in 28.35 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide1.16235 g  in 28.35 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
NYLON-12 (UNII: 446U8J075B)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MICA (UNII: V8A1AW0880)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ORIGANUM MAJORANA WHOLE (UNII: R40XM3HU5X)  
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-360-601 in 1 CARTON09/01/201112/31/2020
128.35 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/201112/31/2020
CLE DE PEAU BEAUTE SILKY FOUNDATION I   B10
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-361
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.53865 g  in 28.35 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide1.16235 g  in 28.35 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
NYLON-12 (UNII: 446U8J075B)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MICA (UNII: V8A1AW0880)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ORIGANUM MAJORANA WHOLE (UNII: R40XM3HU5X)  
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-361-601 in 1 CARTON09/01/201106/30/2017
128.35 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/201106/30/2017
CLE DE PEAU BEAUTE SILKY FOUNDATION I   B20
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-362
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.53865 g  in 28.35 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide1.16235 g  in 28.35 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
NYLON-12 (UNII: 446U8J075B)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MICA (UNII: V8A1AW0880)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ORIGANUM MAJORANA WHOLE (UNII: R40XM3HU5X)  
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-362-601 in 1 CARTON09/01/201112/31/2020
128.35 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/201112/31/2020
CLE DE PEAU BEAUTE SILKY FOUNDATION I   B30
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-363
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.53865 g  in 28.35 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide1.16235 g  in 28.35 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
NYLON-12 (UNII: 446U8J075B)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MICA (UNII: V8A1AW0880)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ORIGANUM MAJORANA WHOLE (UNII: R40XM3HU5X)  
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-363-601 in 1 CARTON09/01/201111/30/2016
128.35 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/201111/30/2016
Labeler - SHISEIDO CO., LTD. (690536453)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO CO., LTD.695589382MANUFACTURE(52685-356, 52685-357, 52685-358, 52685-359, 52685-360, 52685-361, 52685-362, 52685-363) , ANALYSIS(52685-356, 52685-357, 52685-358, 52685-359, 52685-360, 52685-361, 52685-362, 52685-363)

Revised: 9/2023
 
SHISEIDO CO., LTD.