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

DIMETHICONE•WATER•DIPROPYLENE GLYCOL•JOJOBA ESTERS•TRIETHYLHEXANOIN•GLYCERIN•PEG-10 DIMETHICONE•PARAFFIN•POLYETHYLENE•BARIUM SULFATE•TREHALOSE•PEG/PPG-14/7 DIMETHYL ETHER•DIPEPTIDE-15•PAEONIA SUFFRUTICOSA ROOT EXTRACT•ROSA ROXBURGHII FRUIT EXTRACT•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•SODIUM ACETYLATED HYALURONATE•TRIMETHYLSILOXYSILICATE•HYDROLYZED SILK•POLYQUATERNIUM-51•HYDROLYZED CONCHIOLIN PROTEIN•SORBITAN SESQUIISOSTEARATE•MICROCRYSTALLINE WAX•PALMITIC ACID•ORYZA SATIVA (RICE) BRAN WAX•DISTEARYLDIMONIUM CHLORIDE•DISTEARDIMONIUM HECTORITE•TRISODIUM EDTA•HYDROGEN DIMETHICONE•POLYMETHYLSILSESQUIOXANE•SODIUM METAPHOSPHATE•ALUMINA•BHT•CELLULOSE GUM•BUTYLENE GLYCOL•ALCOHOL•ISOPROPYL ALCOHOL•TOCOPHEROL•VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER•SYNTHETIC FLUORPHLOGOPITE•PETROLATUM•POLYSILICONE-2•TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE•DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE•THEANINE•SILICA•ALUMINUM HYDROXIDE•METHICONE•TETRADECENE•METHYLPARABEN•ETHYLPARABEN•PHENOXYETHANOL•FRAGRANCE•TITANIUM DIOXIDE•MICA•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

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 - Ivory

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 - Ocher

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 - Mocha

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.

PRINCIPAL DISPLAY PANEL - 9 g Bottle Carton - Beige

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2017

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

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

CLÉ DE PEAU BEAUTÉ RADIANT STICK FOUNDATION

Active ingredients

Purpose

Uses

Warnings

Directions

Inactive Ingredients

Other information

Questions or comments?

PRINCIPAL DISPLAY PANEL - 9 g Bottle Carton - Ivory

PRINCIPAL DISPLAY PANEL - 9 g Bottle Carton - Ocher

PRINCIPAL DISPLAY PANEL - 9 g Bottle Carton - Mocha

PRINCIPAL DISPLAY PANEL - 9 g Bottle Carton - Beige