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

CLE DE PEAU BEAUTE SILKY FOUNDATION I by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE SILKY FOUNDATION I by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients		Purpose
OCTINOXATE	1.9%	Sunscreen
TITANUIM DIOXIDE	4.1％	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

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 - 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 - 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 - 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 - 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 - B10

33098-43-5040

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

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

clé de peau

BEAUTÉ

silky cream foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

25mL NET WT. .91 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE SILKY FOUNDATION I  BF20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-153
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	539 mg  in 28.35 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.16 g  in 28.35 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
NYLON-12 (UNII: 446U8J075B)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-153-60	1 in 1 CARTON	02/01/2014
1		28.35 g in 1 TUBE; 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	02/01/2014

CLE DE PEAU BEAUTE SILKY FOUNDATION I  I10
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-154
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	539 mg  in 28.35 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.16 g  in 28.35 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
NYLON-12 (UNII: 446U8J075B)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-154-60	1 in 1 CARTON	02/01/2014
1		28.35 g in 1 TUBE; 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	02/01/2014

CLE DE PEAU BEAUTE SILKY FOUNDATION I  O10
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-155
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	539 mg  in 28.35 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.16 g  in 28.35 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
NYLON-12 (UNII: 446U8J075B)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-155-60	1 in 1 CARTON	02/01/2014
1		28.35 g in 1 TUBE; 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	02/01/2014

CLE DE PEAU BEAUTE SILKY FOUNDATION I  O20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-156
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	539 mg  in 28.35 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.16 g  in 28.35 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
NYLON-12 (UNII: 446U8J075B)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-156-60	1 in 1 CARTON	02/01/2014
1		28.35 g in 1 TUBE; 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	02/01/2014

CLE DE PEAU BEAUTE SILKY FOUNDATION I  O30
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-157
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	539 mg  in 28.35 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.16 g  in 28.35 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
NYLON-12 (UNII: 446U8J075B)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-157-60	1 in 1 CARTON	02/01/2014
1		28.35 g in 1 TUBE; 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	02/01/2014

CLE DE PEAU BEAUTE SILKY FOUNDATION I  B10
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-158
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	539 mg  in 28.35 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.16 g  in 28.35 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
NYLON-12 (UNII: 446U8J075B)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-158-60	1 in 1 CARTON	02/01/2014
1		28.35 g in 1 TUBE; 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	02/01/2014

CLE DE PEAU BEAUTE SILKY FOUNDATION I  B20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-159
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	539 mg  in 28.35 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.16 g  in 28.35 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
NYLON-12 (UNII: 446U8J075B)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-159-60	1 in 1 CARTON	02/01/2014
1		28.35 g in 1 TUBE; 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	02/01/2014

CLE DE PEAU BEAUTE SILKY FOUNDATION I  B30
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	539 mg  in 28.35 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.16 g  in 28.35 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
NYLON-12 (UNII: 446U8J075B)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-160-60	1 in 1 CARTON	02/01/2014
1		28.35 g in 1 TUBE; 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	02/01/2014

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-153, 58411-154, 58411-155, 58411-156, 58411-157, 58411-158, 58411-159, 58411-160) , analysis(58411-153, 58411-154, 58411-155, 58411-156, 58411-157, 58411-158, 58411-159, 58411-160)