CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION BF20- octinoxate emulsion CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION I10- octinoxate emulsion CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O10- octinoxate emulsion CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O20- octinoxate emulsion CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O30- octinoxate emulsion CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION B10- octinoxate emulsion CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION B20- octinoxate emulsion CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION B30- octinoxate emulsion

CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION 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

OCTINOXATE 4.9%

Purpose

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, CYCLOMETHICONE, DIPROPYLENE GLYCOL, DIPHENYLSILOXY PHENYL TRIMETHICONE, GLYCERIN, HYDROGENATED POLYISOBUTENE, MICA, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG-10 DIMETHICONE, SYNTHETIC FLUORPHLOGOPITE, PEG-6, PEG-32, BIS-BUTYLDIMETHICONE POLYGLYCERYL-3, IRON OXIDES, BARIUM SULFATE, SODIUM GLUTAMATE, SORBITAN SESQUIISOSTEARATE, DISTEARDIMONIUM HECTORITE, PHENOXYETHANOL, SODIUM DEHYDROACETATE, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, TRIETHOXYCAPRYLYLSILANE, FRAGRANCE, DIMETHICONE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE, BUTYLENE GLYCOL, POLYSILICONE-2, TOCOPHERYL ACETATE, ALCOHOL, POLYQUATERNIUM-51, BHT, ROSA ROXBURGHII FRUIT EXTRACT, SODIUM ACETYLATED HYALURONATE, TOCOPHEROL, CAMELLIA SINENSIS LEAF EXTRACT, TITANIUM DIOXIDE

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 - 30mL Container Carton - BF20

clé de peau
BEAUTÉ

refining fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 30mL Container Carton - I10

clé de peau
BEAUTÉ

refining fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 30mL Container Carton - O10

clé de peau
BEAUTÉ

refining fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 30mL Container Carton - O20

clé de peau
BEAUTÉ

refining fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 30mL Container Carton - O30

clé de peau
BEAUTÉ

refining fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 30mL Container Carton - B10

clé de peau
BEAUTÉ

refining fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 30mL Container Carton - B20

clé de peau
BEAUTÉ

refining fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 30mL Container Carton - B30

clé de peau
BEAUTÉ

refining fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL.OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION   BF20
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-381
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	1690 mg  in 34.48 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-381-10	1 in 1 CARTON
1		34.48 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2008

CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION   I10
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-382
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	1690 mg  in 34.48 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-382-10	1 in 1 CARTON
1		34.48 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2008

CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION   O10
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-383
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	1690 mg  in 34.48 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-383-10	1 in 1 CARTON
1		34.48 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2008

CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION   O20
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-384
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	1690 mg  in 34.48 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-384-10	1 in 1 CARTON
1		34.48 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2008

CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION   O30
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-385
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	1690 mg  in 34.48 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-385-10	1 in 1 CARTON
1		34.48 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2008

CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION   B10
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-386
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	1690 mg  in 34.48 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-386-10	1 in 1 CARTON
1		34.48 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2008

CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION   B20
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-387
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	1690 mg  in 34.48 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-387-10	1 in 1 CARTON
1		34.48 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2008

CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION   B30
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-388
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	1690 mg  in 34.48 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
MICA (UNII: V8A1AW0880)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BARIUM SULFATE (UNII: 25BB7EKE2E)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-388-10	1 in 1 CARTON
1		34.48 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2008

Labeler - SHISEIDO CO., LTD. (690536453)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO CO., LTD.		695589382	MANUFACTURE(52685-381, 52685-382, 52685-383, 52685-384, 52685-385, 52685-386, 52685-387, 52685-388) , ANALYSIS(52685-381, 52685-382, 52685-383, 52685-384, 52685-385, 52685-386, 52685-387, 52685-388)