CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF10- titanium dioxide emulsion CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION I10- titanium dioxide emulsion CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O10- titanium dioxide emulsion CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O20- titanium dioxide emulsion CLE DE PEAU BEAUTE .......oxide) emulsion CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B100- titanium dioxide emulsion CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF50- titanium dioxide emulsion CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF60- titanium dioxide emulsion CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B90- titanium dioxide emulsion

cle de peau BEAUTE RADIANT FLUID FOUNDATION by

Drug Labeling and Warnings

cle de peau BEAUTE RADIANT FLUID FOUNDATION by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

TITANIUM DIOXIDE 6.6%

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
• reply 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 un 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 ∙ POLYMETHYLSILSESQUIOXANE ∙ GLYCERIN ∙ TRIMETHYLSILOXYSILICATE ∙ BUTYLENE GLYCOL ∙ TALC ∙ DIISOSTEARYL MALATE ∙ PEG-10 DIMETHICONE ∙ POLYGLYCERYL-2 DIISOSTEARATE ∙ BARIUM SULFATE ∙ PEG/PPG-19/19 DIMETHICONE ∙ HYDROGENATED POLYISOBUTENE ∙ DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER ∙ TREHALOSE ∙ ARGANIA SPINOSA KERNEL OIL ∙ GLYCINE ∙ PEG/PPG-14/7 DIMETHYL ETHER ∙ ROSA ROXBURGHII FRUIT EXTRACT ∙ ANGELICA ACUTILOBA ROOT EXTRACT ∙ HYDROLYZED CONCHIOLIN PROTEIN ∙ HYDROLYZED SILK ∙ PERILLA OCYMOIDES LEAF EXTRACT ∙ ALUMINUM HYDROXIDE ∙ STEARIC ACID ∙ DISTEARDIMONIUM HECTORITE ∙ BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 ∙ TRISODIUM EDTA ∙ DIMETHICONE CROSSPOLYMER ∙ DISODIUM STEAROYL GLUTAMATE ∙ ZINC OXIDE ∙ TRIETHOXYCAPRYLYLSILANE ∙ POLYSORBATE 80 ∙ ALCOHOL ∙ THEANINE ∙ TOCOPHEROL ∙ HYPERICUM ERECTUM FLOWER/LEAF/STEM EXTRACT ∙ SODIUM METABISULFITE ∙ PHENOXYETHANOL ∙ SODIUM DEHYDROACETATE ∙ FRAGRANCE ∙ IRON OXIDES ∙ TITANIUM DIOXIDE ∙ 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 Bottle Carton - BF10 - LIGHT BUFF

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - I10 - VERY LIGHT IVORY

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O10 - LIGHT OCHER

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O20 - LIGHT MEDIUM OCHER

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O30 - MEDIUM OCHER

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O40 - LIGHT TAN OCHER

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O50 - TAN OCHER

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O60 - DEEP TAN OCHER

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O70 - MEDIUM DEEP OCHER

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O80 - DEEP OCHER

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O90 - VERY DEEP OCHER

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O100 - RICH DEEP OCHER

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B10 - LIGHT BEIGE

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B20 - LIGHT MEDIUM BEIGE

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B30 - MEDIUM BEIGE

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B40 - LIGHT TAN BEIGE

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B50 - TAN BEIGE

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B60 - DEEP TAN BEIGE

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B70 - MEDIUM DEEP BEIGE

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B80 - DEEP BEIGE

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B100 - RICH DEEP BEIGE

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - BF50 - TAN BUFF

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - BF60 - DEEP TAN BUFF

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B90 - VERY DEEP BEIGE

clé de peau
BEAUTÉ

RADIANT FLUID
FOUNDATION
MATTE

BROAD SPECTRUM
SPF 20
SUNSCREEN

35mL NET WT. 1.1 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   BF10
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-537
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-537-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   I10
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-538
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-538-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O10
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-539
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-539-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O20
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-540
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-540-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O30
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-541
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-541-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O40
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-542
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-542-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O50
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-543
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-543-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O60
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-544
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-544-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O70
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-545
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-545-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O80
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-546
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-546-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O90
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-547
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-547-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O100
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-548
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-548-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B10
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-549
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-549-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B20
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-550
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-550-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B30
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-551
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-551-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B40
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-552
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-552-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B50
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-553
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-553-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B60
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-554
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-554-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B70
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-555
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-555-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B80
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-556
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-556-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B100
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-557
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-557-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   BF50
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-558
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-558-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   BF60
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-559
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-559-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B90
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-560
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.72118 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCINE (UNII: TE7660XO1C)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
THEANINE (UNII: 8021PR16QO)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
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: 58411-560-10	1 in 1 CARTON	07/01/2020
1		35 mL 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 DRUG	M020	07/01/2020

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	ANALYSIS(58411-537, 58411-538, 58411-539, 58411-540, 58411-541, 58411-542, 58411-543, 58411-544, 58411-545, 58411-546, 58411-547, 58411-548, 58411-549, 58411-550, 58411-551, 58411-552, 58411-553, 58411-554, 58411-555, 58411-556, 58411-557, 58411-558, 58411-559, 58411-560) , MANUFACTURE(58411-537, 58411-538, 58411-539, 58411-540, 58411-541, 58411-542, 58411-543, 58411-544, 58411-545, 58411-546, 58411-547, 58411-548, 58411-549, 58411-550, 58411-551, 58411-552, 58411-553, 58411-554, 58411-555, 58411-556, 58411-557, 58411-558, 58411-559, 58411-560)