CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O40- octinoxate cream CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O50- octinoxate cream CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O60- octinoxate cream

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, GLYCERIN, DIPHENYLSILOXY PHENYL TRIMETHICONE, HYDROGENATED POLYISOBUTENE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG-10 DIMETHICONE, SYNTHETIC FLUORPHLOGOPITE, PEG-6, PEG-32, BIS-BUTYLDIMETHICONE POLYGLYCERYL-3, SORBITAN SESQUIISOSTEARATE, SODIUM GLUTAMATE, BARIUM SULFATE, TOCOPHERYL ACETATE, POLYQUATERNIUM-51, SODIUM ACETYLATED HYALURONATE, ROSA ROXBURGHII FRUIT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, ALUMINA, ALUMINUM DISTEARATE, TRIETHOXYCAPRYLYLSILANE, POLYSILICONE-2, DIMETHICONE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE, BUTYLENE GLYCOL, ALCOHOL, BHT, TOCOPHEROL, 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 - 30 mL Container Carton (O40)

clé de peau
BEAUTÉ

refining fluid foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton (O50)

clé de peau
BEAUTÉ

refining fluid foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Container Carton (O60)

clé de peau
BEAUTÉ

refining fluid foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

30mL 1 FL. OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION   O40
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-464
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)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
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: 52685-464-10	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	02/01/2013

CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION   O50
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-465
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)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
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: 52685-465-10	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	02/01/2013

CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION   O60
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-466
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)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
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: 52685-466-10	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	02/01/2013

Labeler - SHISEIDO CO., LTD. (690536453)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO CO., LTD.		695589382	MANUFACTURE(52685-464, 52685-465, 52685-466) , ANALYSIS(52685-464, 52685-465, 52685-466)