CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL BF10- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL O80- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL O90- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL B50- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL B60- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL B80- octinoxate and titanium dioxide emulsion

cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL by

Drug Labeling and Warnings

cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL 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 4.9%	Sunscreen
TITANIUM DIOXIDE 3.3%	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 useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif 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･DIMETHICONE･GLYCERIN･BUTYLENE GLYCOL･TRIMETHYLSILOXYSILICATE･POLYMETHYLSILSESQUIOXANE･ISODODECANE･CAPRYLYL METHICONE･BIS-BUTYLDIMETHICONE POLYGLYCERYL-3･PEG-10 DIMETHICONE･ISOPROPYL MYRISTATE･SYNTHETIC FLUORPHLOGOPITE･DIMETHICONE/PEG-10/15 CROSSPOLYMER･ERYTHRITOL･XYLITOL･BARIUM SULFATE･PYRUS CYDONIA SEED EXTRACT･TREHALOSE･ARGANIA SPINOSA KERNEL OIL･GLYCINE･PEG/PPG-14/7 DIMETHYL ETHER･CITRUS JUNOS SEED EXTRACT･ROSA ROXBURGHII FRUIT EXTRACT･ANGELICA ACUTILOBA ROOT EXTRACT･HYDROLYZED CONCHIOLIN PROTEIN･HYDROLYZED SILK･DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER･PERILLA OCYMOIDES LEAF EXTRACT･ISOSTEARIC ACID･BIS-BEHENYL/PHYTOSTERYL DIMER DILINOLEATE･DIISOSTEARYL MALATE･DISTEARDIMONIUM HECTORITE･ALUMINUM HYDROXIDE･STEARIC ACID･TRISODIUM EDTA･POLYSILICONE-2･TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE･BHT･ALCOHOL･CITRIC ACID･SODIUM CITRATE･TRIETHOXYCAPRYLYLSILANE･DIPROPYLENE GLYCOL･TOCOPHEROL･DISODIUM STEAROYL GLUTAMATE･SODIUM METABISULFITE･THEANINE･PHENOXYETHANOL･METHYLPARABEN･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 - 35 mL Vial Carton - BF10

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
NATURAL

BROAD SPECTRUM
SPF 25
SUNSCREEN

35mL 1.1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - O80

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
NATURAL

BROAD SPECTRUM
SPF 25
SUNSCREEN

35mL 1.1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - O90

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
NATURAL

BROAD SPECTRUM
SPF 25
SUNSCREEN

35mL 1.1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - B50

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
NATURAL

BROAD SPECTRUM
SPF 25
SUNSCREEN

35mL 1.1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - B60

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
NATURAL

BROAD SPECTRUM
SPF 25
SUNSCREEN

35mL 1.1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Vial Carton - B80

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
NATURAL

BROAD SPECTRUM
SPF 25
SUNSCREEN

35mL 1.1 FL. OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL   BF10
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-901
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.715 g  in 35 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.155 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
ISODODECANE (UNII: A8289P68Y2)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
ERYTHRIN (UNII: 4TJZ1118I8)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CYDONIA OBLONGA SEED (UNII: JXU526QH1V)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)
HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ISOSTEARIC ACID (UNII: X33R8U0062)
BEHENYL PHOSPHATE (UNII: 366D9UAY69)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
POLYSILICONE-15 (UNII: F8DRP5BB29)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TOCOPHEROL (UNII: R0ZB2556P8)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
FRAGRANCE 13576 (UNII: 5EM498GW35)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
MICA (UNII: V8A1AW0880)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-901-20	35 in 1 CARTON	01/01/2021
1	NDC: 58411-901-70	35 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2021

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL   O80
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-896
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.715 g  in 35 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.155 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
ISODODECANE (UNII: A8289P68Y2)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
ERYTHRIN (UNII: 4TJZ1118I8)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CYDONIA OBLONGA SEED (UNII: JXU526QH1V)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)
HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ISOSTEARIC ACID (UNII: X33R8U0062)
BEHENYL PHOSPHATE (UNII: 366D9UAY69)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
POLYSILICONE-15 (UNII: F8DRP5BB29)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TOCOPHEROL (UNII: R0ZB2556P8)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
FRAGRANCE 13576 (UNII: 5EM498GW35)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
MICA (UNII: V8A1AW0880)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-896-20	35 in 1 CARTON	01/01/2021
1	NDC: 58411-896-70	35 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2021

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL   O90
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-897
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.715 g  in 35 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.155 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
ISODODECANE (UNII: A8289P68Y2)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
ERYTHRIN (UNII: 4TJZ1118I8)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CYDONIA OBLONGA SEED (UNII: JXU526QH1V)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)
HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ISOSTEARIC ACID (UNII: X33R8U0062)
BEHENYL PHOSPHATE (UNII: 366D9UAY69)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
POLYSILICONE-15 (UNII: F8DRP5BB29)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TOCOPHEROL (UNII: R0ZB2556P8)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
FRAGRANCE 13576 (UNII: 5EM498GW35)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
MICA (UNII: V8A1AW0880)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-897-20	35 in 1 CARTON	01/01/2021
1	NDC: 58411-897-70	35 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2021

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL   B50
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-898
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.715 g  in 35 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.155 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
ISODODECANE (UNII: A8289P68Y2)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
ERYTHRIN (UNII: 4TJZ1118I8)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CYDONIA OBLONGA SEED (UNII: JXU526QH1V)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)
HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ISOSTEARIC ACID (UNII: X33R8U0062)
BEHENYL PHOSPHATE (UNII: 366D9UAY69)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
POLYSILICONE-15 (UNII: F8DRP5BB29)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TOCOPHEROL (UNII: R0ZB2556P8)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
FRAGRANCE 13576 (UNII: 5EM498GW35)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
MICA (UNII: V8A1AW0880)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-898-20	35 in 1 CARTON	01/01/2021
1	NDC: 58411-898-70	35 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2021

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL   B60
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-899
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.715 g  in 35 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.155 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
ISODODECANE (UNII: A8289P68Y2)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
ERYTHRIN (UNII: 4TJZ1118I8)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CYDONIA OBLONGA SEED (UNII: JXU526QH1V)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)
HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ISOSTEARIC ACID (UNII: X33R8U0062)
BEHENYL PHOSPHATE (UNII: 366D9UAY69)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
POLYSILICONE-15 (UNII: F8DRP5BB29)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TOCOPHEROL (UNII: R0ZB2556P8)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
FRAGRANCE 13576 (UNII: 5EM498GW35)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
MICA (UNII: V8A1AW0880)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-899-20	35 in 1 CARTON	01/01/2021
1	NDC: 58411-899-70	35 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2021

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION NATURAL   B80
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-900
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.715 g  in 35 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.155 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
ISODODECANE (UNII: A8289P68Y2)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BIS(BUTYLAMINO)DIMETHYLSILANE (UNII: YG6YAQ6XCX)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
ERYTHRIN (UNII: 4TJZ1118I8)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CYDONIA OBLONGA SEED (UNII: JXU526QH1V)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
HYDROLYZED CAPRA HIRCUS HAIR PROTEIN (ENZYMATIC; 4000 MW) (UNII: 2428CXY2LA)
HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ISOSTEARIC ACID (UNII: X33R8U0062)
BEHENYL PHOSPHATE (UNII: 366D9UAY69)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
POLYSILICONE-15 (UNII: F8DRP5BB29)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TOCOPHEROL (UNII: R0ZB2556P8)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
FRAGRANCE 13576 (UNII: 5EM498GW35)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
MICA (UNII: V8A1AW0880)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-900-20	35 in 1 CARTON	01/01/2021
1	NDC: 58411-900-70	35 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2021

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Registrant - Shiseido America Inc. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	analysis(58411-896, 58411-897, 58411-898, 58411-899, 58411-900, 58411-901) , manufacture(58411-896, 58411-897, 58411-898, 58411-899, 58411-900, 58411-901)