CLE DE PEAU BEAUTE CONCEALER N 1- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 2- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 3- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 4- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 5- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 7- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 8- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 9- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 10- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 11- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 12- titanium dioxide stick
CLE DE PEAU BEAUTE CONCEALER N 13- titanium dioxide stick
SHISEIDO AMERICAS CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

clé de peau BEAUTÉ CONCEALER N

Drug Facts

Active ingredients

TITANIUM DIOXIDE 1.6%

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
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

HYDROGENATED POLYDECENE•DIMETHICONE•KAOLIN•NEOPENTYL GLYCOL DIHEPTANOATE•DIPHENYLSILOXY PHENYL TRIMETHICONE•LITHIUM MAGNESIUM SODIUM SILICATE•POLYETHYLENE•PARAFFIN•COPERNICIA CERIFERA (CARNAUBA) WAX•SORBITAN SESQUIISOSTEARATE•MICROCRYSTALLINE WAX•GLYCERIN•BARIUM SULFATE•PHYTOSTERYL MACADAMIATE•ARGANIA SPINOSA KERNEL OIL•TOCOPHERYL ACETATE•SODIUM ACETYLATED HYALURONATE•ROSA ROXBURGHII FRUIT EXTRACT•ZINGIBER AROMATICUS EXTRACT•ALUMINUM HYDROXIDE•DIPROPYLENE GLYCOL•PEG-10 DIMETHICONE•WATER•STEARIC ACID•ALCOHOL•BUTYLENE GLYCOL•TOCOPHEROL•SIMETHICONE•BHT•CHLORPHENESIN•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 - 5 g Cartridge Carton - 1

clé de peau
BEAUTÉ

CONCEALER N
BROAD SPECTRUM
SPF 27
SUNSCREEN

seamless finish
long-lasting

5g NET WT. .17 OZ.

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 1

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 2

clé de peau
BEAUTÉ

CONCEALER N
BROAD SPECTRUM
SPF 27
SUNSCREEN

seamless finish
long-lasting

5g NET WT. .17 OZ.

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 2

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 3

clé de peau
BEAUTÉ

CONCEALER N
BROAD SPECTRUM
SPF 27
SUNSCREEN

seamless finish
long-lasting

5g NET WT. .17 OZ.

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 3

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 4

clé de peau
BEAUTÉ

CONCEALER N
BROAD SPECTRUM
SPF 27
SUNSCREEN

seamless finish
long-lasting

5g NET WT. .17 OZ.

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 4

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 5

clé de peau
BEAUTÉ

CONCEALER N
BROAD SPECTRUM
SPF 27
SUNSCREEN

seamless finish
long-lasting

5g NET WT. .17 OZ.

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 5

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 7

clé de peau
BEAUTÉ

CONCEALER N
BROAD SPECTRUM
SPF 27
SUNSCREEN

seamless finish
long-lasting

5g NET WT. .17 OZ.

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 7

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 8

clé de peau
BEAUTÉ

CONCEALER N
BROAD SPECTRUM
SPF 27
SUNSCREEN

seamless finish
long-lasting

5g NET WT. .17 OZ.

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 8

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 9

clé de peau
BEAUTÉ

CONCEALER N
BROAD SPECTRUM
SPF 27
SUNSCREEN

seamless finish
long-lasting

5g NET WT. .17 OZ.

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 9

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 10

clé de peau
BEAUTÉ

CONCEALER N
BROAD SPECTRUM
SPF 27
SUNSCREEN

seamless finish
long-lasting

5g NET WT. .17 OZ.

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 10

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 11

clé de peau
BEAUTÉ

CONCEALER N
BROAD SPECTRUM
SPF 27
SUNSCREEN

seamless finish
long-lasting

5g NET WT. .17 OZ.

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 11

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 12

clé de peau
BEAUTÉ

CONCEALER N
BROAD SPECTRUM
SPF 27
SUNSCREEN

seamless finish
long-lasting

5g NET WT. .17 OZ.

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 12

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 13

clé de peau
BEAUTÉ

CONCEALER N
BROAD SPECTRUM
SPF 27
SUNSCREEN

seamless finish
long-lasting

5g NET WT. .17 OZ.

PRINCIPAL DISPLAY PANEL - 5 g Cartridge Carton - 13

CLE DE PEAU BEAUTE CONCEALER N 1
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-658
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg in 5 g

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
DIMETHICONE (UNII: 92RU3N3Y1O)
KAOLIN (UNII: 24H4NWX5CO)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
LAPONITE (UNII: D703131383)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PARAFFIN (UNII: I9O0E3H2ZE)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
GLYCERIN (UNII: PDC6A3C0OX)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-658-20	1 in 1 CARTON	01/01/2022
1		5 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	01/01/2022

CLE DE PEAU BEAUTE CONCEALER N 2
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-659
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg in 5 g

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
DIMETHICONE (UNII: 92RU3N3Y1O)
KAOLIN (UNII: 24H4NWX5CO)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
LAPONITE (UNII: D703131383)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PARAFFIN (UNII: I9O0E3H2ZE)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
GLYCERIN (UNII: PDC6A3C0OX)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-659-20	1 in 1 CARTON	01/01/2022
1		5 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	01/01/2022

CLE DE PEAU BEAUTE CONCEALER N 3
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-660
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg in 5 g

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
DIMETHICONE (UNII: 92RU3N3Y1O)
KAOLIN (UNII: 24H4NWX5CO)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
LAPONITE (UNII: D703131383)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PARAFFIN (UNII: I9O0E3H2ZE)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
GLYCERIN (UNII: PDC6A3C0OX)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-660-20	1 in 1 CARTON	01/01/2022
1		5 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	01/01/2022

CLE DE PEAU BEAUTE CONCEALER N 4
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-661
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg in 5 g

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
DIMETHICONE (UNII: 92RU3N3Y1O)
KAOLIN (UNII: 24H4NWX5CO)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
LAPONITE (UNII: D703131383)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PARAFFIN (UNII: I9O0E3H2ZE)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
GLYCERIN (UNII: PDC6A3C0OX)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-661-20	1 in 1 CARTON	01/01/2022
1		5 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	01/01/2022

CLE DE PEAU BEAUTE CONCEALER N 5
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-662
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg in 5 g

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
DIMETHICONE (UNII: 92RU3N3Y1O)
KAOLIN (UNII: 24H4NWX5CO)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
LAPONITE (UNII: D703131383)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PARAFFIN (UNII: I9O0E3H2ZE)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
GLYCERIN (UNII: PDC6A3C0OX)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-662-20	1 in 1 CARTON	01/01/2022
1		5 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	01/01/2022

CLE DE PEAU BEAUTE CONCEALER N 7
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-663
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg in 5 g

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
DIMETHICONE (UNII: 92RU3N3Y1O)
KAOLIN (UNII: 24H4NWX5CO)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
LAPONITE (UNII: D703131383)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PARAFFIN (UNII: I9O0E3H2ZE)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
GLYCERIN (UNII: PDC6A3C0OX)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-663-20	1 in 1 CARTON	01/01/2022
1		5 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	01/01/2022

CLE DE PEAU BEAUTE CONCEALER N 8
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-664
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg in 5 g

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
DIMETHICONE (UNII: 92RU3N3Y1O)
KAOLIN (UNII: 24H4NWX5CO)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
LAPONITE (UNII: D703131383)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PARAFFIN (UNII: I9O0E3H2ZE)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
GLYCERIN (UNII: PDC6A3C0OX)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-664-20	1 in 1 CARTON	01/01/2022
1		5 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	01/01/2022

CLE DE PEAU BEAUTE CONCEALER N 9
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-665
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg in 5 g

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
DIMETHICONE (UNII: 92RU3N3Y1O)
KAOLIN (UNII: 24H4NWX5CO)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
LAPONITE (UNII: D703131383)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PARAFFIN (UNII: I9O0E3H2ZE)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
GLYCERIN (UNII: PDC6A3C0OX)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-665-20	1 in 1 CARTON	01/01/2022
1		5 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	01/01/2022

CLE DE PEAU BEAUTE CONCEALER N 10
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-666
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg in 5 g

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
DIMETHICONE (UNII: 92RU3N3Y1O)
KAOLIN (UNII: 24H4NWX5CO)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
LAPONITE (UNII: D703131383)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PARAFFIN (UNII: I9O0E3H2ZE)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
GLYCERIN (UNII: PDC6A3C0OX)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-666-20	1 in 1 CARTON	01/01/2022
1		5 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	01/01/2022

CLE DE PEAU BEAUTE CONCEALER N 11
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-667
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg in 5 g

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
DIMETHICONE (UNII: 92RU3N3Y1O)
KAOLIN (UNII: 24H4NWX5CO)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
LAPONITE (UNII: D703131383)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PARAFFIN (UNII: I9O0E3H2ZE)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
GLYCERIN (UNII: PDC6A3C0OX)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-667-20	1 in 1 CARTON	01/01/2022
1		5 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	01/01/2022

CLE DE PEAU BEAUTE CONCEALER N 12
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-668
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg in 5 g

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
DIMETHICONE (UNII: 92RU3N3Y1O)
KAOLIN (UNII: 24H4NWX5CO)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
LAPONITE (UNII: D703131383)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PARAFFIN (UNII: I9O0E3H2ZE)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
GLYCERIN (UNII: PDC6A3C0OX)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-668-20	1 in 1 CARTON	01/01/2022
1		5 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	01/01/2022

CLE DE PEAU BEAUTE CONCEALER N 13
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-669
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg in 5 g

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
DIMETHICONE (UNII: 92RU3N3Y1O)
KAOLIN (UNII: 24H4NWX5CO)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
LAPONITE (UNII: D703131383)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PARAFFIN (UNII: I9O0E3H2ZE)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
GLYCERIN (UNII: PDC6A3C0OX)
BARIUM SULFATE (UNII: 25BB7EKE2E)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-669-20	1 in 1 CARTON	01/01/2022
1		5 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	01/01/2022

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Revised: 11/2021

Document Id: 15776259-d96c-4dc6-ad67-2abe51d8bc38

Set id: eedf8065-8897-4773-9cbb-bab57d2dd04f

Version: 1

Effective Time: 20211118

SHISEIDO AMERICAS CORPORATION