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

CLE DE PEAU BEAUTE UV PROTECTIVE TINTED by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE UV PROTECTIVE TINTED 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 INGREDIENT

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

WATERDIPROPYLENE GLYCOLDIMETHICONEISOPROPYL MYRISTATEGLYCERINCYCLOPENTASILOXANESD ALCOHOL 40-BLAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEMETHYL METHACRYLATE CROSSPOLYMERDISTEARDIMONIUM HECTORITEPOLYMETHYLSILSESQUIOXANEPEG/PPG-14/7 DIMETHYL ETHERCETYL PEG/PPG-10/1 DIMETHICONESILICASORBITAN SESQUIISOSTEARATETREHALOSEDEXTRIN PALMITATETOCOPHERYL ACETATEPOLYQUATERNIUM-51SODIUM ACETYLATED HYALURONATEDIPOTASSIUM GLYCYRRHIZATESAXIFRAGA SARMENTOSA EXTRACTGINKGO BILOBA LEAF EXTRACTTHYMUS SERPYLLUM EXTRACTHYDROLYZED SILK2-O-ETHYL ASCORBIC ACIDSCUTELLARIA BAICALENSIS ROOT EXTRACTUNCARIA GAMBIR EXTRACTGARCINIA MANGOSTANA BARK EXTRACTHIBISCUS SABDARIFFA FLOWER EXTRACTPANAX GINSENG ROOT EXTRACTBUPLEURUM FALCATUM ROOT EXTRACTHYDROLYZED CONCHIOLIN PROTEINPPG-17HYDRATED SILICATRIETHOXYCAPRYLYLSILANEBUTYLENE GLYCOLTRISODIUM EDTAALUMINUM HYDROXIDEPOLYSILICONE-2ALCOHOLDISTEARYLDIMONIUM CHLORIDEBHTTOCOPHEROLSODIUM METABISULFITETALCTHEANINEMETHYLPARABENPHENOXYETHANOLFRAGRANCETITANIUM DIOXIDEIRON OXIDESMICA

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 - 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 - DARK

clé de peau
BEAUTÉ

50+

UV protective cream
tinted

BROAD SPECTRUM
SPF 50+
SUNSCREEN

30mL NET WT. 1.2 OZ.

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 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 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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 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 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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 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(58411-292, 58411-293, 58411-294) , analysis(58411-292, 58411-293, 58411-294)