CLE DE PEAU BEAUTE PW FOUNDATION S BF20- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE PW FOUNDATION S I10- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE PW FOUNDATION S O10- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE PW FOUNDATION S O20- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE PW FOUNDATION S O30- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE PW FOUNDATION S B10- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE PW FOUNDATION S B20- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE PW FOUNDATION S B30- octinoxate and titanium dioxide powder

CLE DE PEAU BEAUTE PW FOUNDATION s by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE PW FOUNDATION s 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

Active ingredients		Purpose
OCTINOXATE	1.9%	Sunscreen
TITANIUM DIOXIDE	3.3%	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

TALC, SYNTHETIC FLUORPHLOGOPITE, BARIUM SULFATE∙ DIMETHICONE, TRIETHYLHEXANOIN, BIS-BEHENYL/PHYTOSTERYL DIMER DILINOLEATE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SILICA, NYLON-12, SILICA DIMETHYL SILYLATE, TOCOPHERYL ACETATE, PRUNUS SPECIOSA LEAF EXTRACT∙ SODIUM ACETYLATED HYALURONATE, ROSA ROXBURGHII FRUIT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, SORBITAN SESQUIISOSTEARATE, TRIETHOXYSILYLETHYL, POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, METHICONE, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE, SODIUM MAGNESIUM SILICATE, POLYSILICONE-2, GLYCERIN, TOCOPHEROL, WATER, BUTYLENE GLYCOL, ALCOHOL, BHT, CHLORPHENESIN, FRAGRANCE, TITANIUM DIOXIDE, MICA, ZINC OXIDE, IRON OXIDES

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 - 11 g Tray Carton - BF20

clé de peau
BEAUTÉ

powder foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - I10

clé de peau
BEAUTÉ

powder foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - O10

clé de peau
BEAUTÉ

powder foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - O20

clé de peau
BEAUTÉ

powder foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - O30

clé de peau
BEAUTÉ

powder foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - B10

clé de peau
BEAUTÉ

powder foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - B20

clé de peau
BEAUTÉ

powder foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - B30

clé de peau
BEAUTÉ

powder foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

11g NET WT. .38 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE PW FOUNDATION S   BF20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-364
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	209 mg  in 11 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	363 mg  in 11 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-364-30	1 in 1 CARTON
1		11 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2009

CLE DE PEAU BEAUTE PW FOUNDATION S   I10
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-365
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	209 mg  in 11 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	363 mg  in 11 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-365-30	1 in 1 CARTON
1		11 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2009

CLE DE PEAU BEAUTE PW FOUNDATION S   O10
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-366
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	209 mg  in 11 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	363 mg  in 11 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-366-30	1 in 1 CARTON
1		11 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2009

CLE DE PEAU BEAUTE PW FOUNDATION S   O20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-367
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	209 mg  in 11 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	363 mg  in 11 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-367-30	1 in 1 CARTON
1		11 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2009

CLE DE PEAU BEAUTE PW FOUNDATION S   O30
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-368
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	209 mg  in 11 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	363 mg  in 11 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-368-30	1 in 1 CARTON
1		11 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2009

CLE DE PEAU BEAUTE PW FOUNDATION S   B10
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-369
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	209 mg  in 11 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	363 mg  in 11 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-369-30	1 in 1 CARTON
1		11 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2009

CLE DE PEAU BEAUTE PW FOUNDATION S   B20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-370
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	209 mg  in 11 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	363 mg  in 11 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-370-30	1 in 1 CARTON
1		11 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2009

CLE DE PEAU BEAUTE PW FOUNDATION S   B30
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-371
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	209 mg  in 11 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	363 mg  in 11 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
NYLON-12 (UNII: 446U8J075B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHICONE (20 CST) (UNII: 6777U11MKT)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-371-30	1 in 1 CARTON
1		11 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2009

Labeler - SHISEIDO CO., LTD. (690536453)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO CO., LTD.		695088112	MANUFACTURE(52685-364, 52685-365, 52685-366, 52685-367, 52685-368, 52685-369, 52685-370, 52685-371) , ANALYSIS(52685-364, 52685-365, 52685-366, 52685-367, 52685-368, 52685-369, 52685-370, 52685-371)