CLE DE PEAU BEAUTE RADIANT FOUNDATION IVORY- octinoxate stick CLE DE PEAU BEAUTE RADIANT FOUNDATION OCHER- octinoxate stick CLE DE PEAU BEAUTE RADIANT FOUNDATION MOCHA- octinoxate stick CLE DE PEAU BEAUTE RADIANT FOUNDATION BEIGE- octinoxate stick

CLE DE PEAU BEAUTE RADIANT FOUNDATION by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE RADIANT FOUNDATION 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 ingredients

OCTINOXATE 3.4%

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

DIMETHICONEWATERDIPROPYLENE GLYCOLJOJOBA ESTERSTRIETHYLHEXANOINGLYCERINPEG-10 DIMETHICONEPARAFFINPOLYETHYLENEBARIUM SULFATETREHALOSEPEG/PPG-14/7 DIMETHYL ETHERDIPEPTIDE-15PAEONIA SUFFRUTICOSA ROOT EXTRACTROSA ROXBURGHII FRUIT EXTRACTDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMERSODIUM ACETYLATED HYALURONATETRIMETHYLSILOXYSILICATEHYDROLYZED SILKPOLYQUATERNIUM-51HYDROLYZED CONCHIOLIN PROTEINSORBITAN SESQUIISOSTEARATEMICROCRYSTALLINE WAXPALMITIC ACIDORYZA SATIVA (RICE) BRAN WAXDISTEARYLDIMONIUM CHLORIDEDISTEARDIMONIUM HECTORITETRISODIUM EDTAHYDROGEN DIMETHICONEPOLYMETHYLSILSESQUIOXANESODIUM METAPHOSPHATEALUMINABHTCELLULOSE GUMBUTYLENE GLYCOLALCOHOLISOPROPYL ALCOHOLTOCOPHEROLVINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMERSYNTHETIC FLUORPHLOGOPITEPETROLATUMPOLYSILICONE-2TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONEDIPENTAERYTHRITYL HEXAHYDROXYSTEARATETHEANINESILICAALUMINUM HYDROXIDEMETHICONETETRADECENEMETHYLPARABENETHYLPARABENPHENOXYETHANOLFRAGRANCETITANIUM DIOXIDEMICAIRON 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

PRINCIPAL DISPLAY PANEL - 9 g Bottle Carton - Ivory

clé de peau
BEAUTÉ

radiant stick foundation

BROAD SPECTRUM
SPF 17
SUNSCREEN

9g NET WT. .31 OZ.

PRINCIPAL DISPLAY PANEL - 9 g Bottle Carton - Ocher

clé de peau
BEAUTÉ

radiant stick foundation

BROAD SPECTRUM
SPF 17
SUNSCREEN

9g NET WT. .31 OZ.

PRINCIPAL DISPLAY PANEL - 9 g Bottle Carton - Mocha

clé de peau
BEAUTÉ

radiant stick foundation

BROAD SPECTRUM
SPF 17
SUNSCREEN

9g NET WT. .31 OZ.

PRINCIPAL DISPLAY PANEL - 9 g Bottle Carton - Beige

clé de peau
BEAUTÉ

radiant stick foundation

BROAD SPECTRUM
SPF 17
SUNSCREEN

9g NET WT. .31 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE RADIANT FOUNDATION  IVORY
octinoxate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-284
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	306 mg  in 9 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PARAFFIN (UNII: I9O0E3H2ZE)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
BARIUM SULFATE (UNII: 25BB7EKE2E)
TREHALOSE (UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
DIGLYCINE (UNII: 10525P22U0)
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PALMITIC ACID (UNII: 2V16EO95H1)
RICE BRAN (UNII: R60QEP13IC)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
PETROLATUM (UNII: 4T6H12BN9U)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
THEANINE (UNII: 8021PR16QO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-284-10	1 in 1 CARTON	02/01/2017
1		9 g in 1 BOTTLE; 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	02/01/2017

CLE DE PEAU BEAUTE RADIANT FOUNDATION   OCHER
octinoxate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-285
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	306 mg  in 9 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PARAFFIN (UNII: I9O0E3H2ZE)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
BARIUM SULFATE (UNII: 25BB7EKE2E)
TREHALOSE (UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
DIGLYCINE (UNII: 10525P22U0)
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PALMITIC ACID (UNII: 2V16EO95H1)
RICE BRAN (UNII: R60QEP13IC)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
PETROLATUM (UNII: 4T6H12BN9U)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
THEANINE (UNII: 8021PR16QO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-285-10	1 in 1 CARTON	02/01/2017
1		9 g in 1 BOTTLE; 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	02/01/2017

CLE DE PEAU BEAUTE RADIANT FOUNDATION   MOCHA
octinoxate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-286
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	306 mg  in 9 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PARAFFIN (UNII: I9O0E3H2ZE)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
BARIUM SULFATE (UNII: 25BB7EKE2E)
TREHALOSE (UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
DIGLYCINE (UNII: 10525P22U0)
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PALMITIC ACID (UNII: 2V16EO95H1)
RICE BRAN (UNII: R60QEP13IC)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
PETROLATUM (UNII: 4T6H12BN9U)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
THEANINE (UNII: 8021PR16QO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-286-10	1 in 1 CARTON	02/01/2017
1		9 g in 1 BOTTLE; 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	02/01/2017

CLE DE PEAU BEAUTE RADIANT FOUNDATION   BEIGE
octinoxate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-287
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	306 mg  in 9 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PARAFFIN (UNII: I9O0E3H2ZE)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
BARIUM SULFATE (UNII: 25BB7EKE2E)
TREHALOSE (UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
DIGLYCINE (UNII: 10525P22U0)
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PALMITIC ACID (UNII: 2V16EO95H1)
RICE BRAN (UNII: R60QEP13IC)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
PETROLATUM (UNII: 4T6H12BN9U)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
THEANINE (UNII: 8021PR16QO)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-287-10	1 in 1 CARTON	02/01/2017
1		9 g in 1 BOTTLE; 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	02/01/2017

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-284, 58411-285, 58411-286, 58411-287) , analysis(58411-284, 58411-285, 58411-286, 58411-287)