Drug Facts

Active ingredients	Purpose
OCTINOXATE 7.4%	Sunscreen
OCTOCRYLENE 3.0%	Sunscreen
TITANIUM DIOXIDE 4.6%	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

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•DIPROPYLENE GLYCOL•DIMETHICONE•ISOPROPYL MYRISTATE•GLYCERIN•CYCLOPENTASILOXANE•SD ALCOHOL 40-B•LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•METHYL METHACRYLATE CROSSPOLYMER•DISTEARDIMONIUM HECTORITE•POLYMETHYLSILSESQUIOXANE•PEG/PPG-14/7 DIMETHYL ETHER•CETYL PEG/PPG-10/1 DIMETHICONE•SILICA•SORBITAN SESQUIISOSTEARATE•TREHALOSE•DEXTRIN PALMITATE•TOCOPHERYL ACETATE•POLYQUATERNIUM-51•SODIUM ACETYLATED HYALURONATE•DIPOTASSIUM GLYCYRRHIZATE•SAXIFRAGA SARMENTOSA EXTRACT•GINKGO BILOBA LEAF EXTRACT•THYMUS SERPYLLUM EXTRACT•HYDROLYZED SILK•2-O-ETHYL ASCORBIC ACID•SCUTELLARIA BAICALENSIS ROOT EXTRACT•UNCARIA GAMBIR EXTRACT•GARCINIA MANGOSTANA BARK EXTRACT•HIBISCUS SABDARIFFA FLOWER EXTRACT•PANAX GINSENG ROOT EXTRACT•BUPLEURUM FALCATUM ROOT EXTRACT•HYDROLYZED CONCHIOLIN PROTEIN•PPG-17•HYDRATED SILICA•TRIETHOXYCAPRYLYLSILANE•BUTYLENE GLYCOL•TRISODIUM EDTA•ALUMINUM HYDROXIDE•POLYSILICONE-2•ALCOHOL•DISTEARYLDIMONIUM CHLORIDE•BHT•TOCOPHEROL•SODIUM METABISULFITE•TALC•THEANINE•METHYLPARABEN•PHENOXYETHANOL•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 Tube Carton - IVORY

clé de peau
BEAUTÉ

50+

UV protective cream
tinted

BROAD SPECTRUM
SPF 50+
SUNSCREEN

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - IVORY

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - OCHER

clé de peau
BEAUTÉ

50+

UV protective cream
tinted

BROAD SPECTRUM
SPF 50+
SUNSCREEN

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - OCHER

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - DARK

clé de peau
BEAUTÉ

50+

UV protective cream
tinted

BROAD SPECTRUM
SPF 50+
SUNSCREEN

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - DARK

CLE DE PEAU BEAUTE UV PROTECTIVE TINTED IVORY
octinoxate, octocrylene, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-292
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2449 mg in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	993 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1522 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TREHALOSE (UNII: B8WCK70T7I)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
GINKGO (UNII: 19FUJ2C58T)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
ASIAN GINSENG (UNII: CUQ3A77YXI)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
PPG-17 (UNII: OV0Q322E0U)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TALC (UNII: 7SEV7J4R1U)
THEANINE (UNII: 8021PR16QO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-292-60	1 in 1 CARTON	02/01/2017
1		30 mL in 1 TUBE; 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 UV PROTECTIVE TINTED OCHER
octinoxate, octocrylene, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-293
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2449 mg in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	993 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1522 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TREHALOSE (UNII: B8WCK70T7I)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
GINKGO (UNII: 19FUJ2C58T)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
ASIAN GINSENG (UNII: CUQ3A77YXI)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
PPG-17 (UNII: OV0Q322E0U)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TALC (UNII: 7SEV7J4R1U)
THEANINE (UNII: 8021PR16QO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-293-60	1 in 1 CARTON	02/01/2017
1		30 mL in 1 TUBE; 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 UV PROTECTIVE TINTED DARK
octinoxate, octocrylene, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-294
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2449 mg in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	993 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1522 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TREHALOSE (UNII: B8WCK70T7I)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
GINKGO (UNII: 19FUJ2C58T)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
ASIAN GINSENG (UNII: CUQ3A77YXI)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
PPG-17 (UNII: OV0Q322E0U)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALCOHOL (UNII: 3K9958V90M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TALC (UNII: 7SEV7J4R1U)
THEANINE (UNII: 8021PR16QO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-294-60	1 in 1 CARTON	02/01/2017
1		30 mL in 1 TUBE; 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(58411-292, 58411-293, 58411-294) , analysis(58411-292, 58411-293, 58411-294)

CLÉ DE PEAU BEAUTÉ UV PROTECTIVE TINTED

Uses

Warnings

Directions

Inactive Ingredients

Other information

Questions or comments?

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - IVORY

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - OCHER

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - DARK