CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORY- octinoxate and titanium dioxide cream
CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES BEIGE- octinoxate and titanium dioxide cream
CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES ALMOND- octinoxate and titanium dioxide cream
CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES OCHER- octinoxate and titanium dioxide cream
CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES MOCHA- octinoxate and titanium dioxide cream
CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES DARK- octinoxate and titanium dioxide cream
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 RADIANT CORRECTOR FOR EYES

Drug Facts

Active ingredients	Purpose
OCTINOXATE 1.9%	Sunscreen
TITANIUM DIOXIDE 2.6%	Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

Inactive Ingredients

WATER•DIMETHICONE•BUTYLENE GLYCOL•GLYCERIN•DIISOSTEARYL MALATE•PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•PEG-10 DIMETHICONE•SORBITAN SESQUIISOSTEARATE•TRIMETHYLSILOXYSILICATE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•TREHALOSE•CRATAEGUS MONOGYNA FLOWER EXTRACT•SODIUM ACETYLATED HYALURONATE•ZINGIBER AROMATICUS EXTRACT•PEG/PPG-14/7 DIMETHYL ETHER•ROSA ROXBURGHII FRUIT EXTRACT•POLYQUATERNIUM-51•HYDROLYZED CONCHIOLIN PROTEIN•HYDROLYZED SILK•CAPRYLYL METHICONE•ALUMINUM HYDROXIDE•DISTEARDIMONIUM HECTORITE•POLYSILICONE-2•STEARIC ACID•TRISODIUM EDTA•SODIUM CITRATE•BHT•ALCOHOL•CITRIC ACID•TOCOPHEROL•TALC•SODIUM METABISULFITE•HYDROGEN DIMETHICONE•TIN OXIDE•THEANINE•PHENOXYETHANOL•METHYLPARABEN•ETHYLPARABEN•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 - 2.2 mL Tube Carton - IVORY

clé de peau
BEAUTÉ

radiant corrector
for eyes

BROAD SPECTRUM
SPF 28
SUNSCREEN

2.2mL NET WT. .08 OZ.

PRINCIPAL DISPLAY PANEL - 2.2 mL Tube Carton - IVORY

PRINCIPAL DISPLAY PANEL - 2.2 mL Tube Carton - BEIGE

clé de peau
BEAUTÉ

radiant corrector
for eyes

BROAD SPECTRUM
SPF 28
SUNSCREEN

2.2mL NET WT. .08 OZ.

PRINCIPAL DISPLAY PANEL - 2.2 mL Tube Carton - BEIGE

PRINCIPAL DISPLAY PANEL - 2.2 mL Tube Carton - ALMOND

clé de peau
BEAUTÉ

radiant corrector
for eyes

BROAD SPECTRUM
SPF 28
SUNSCREEN

2.2mL NET WT. .08 OZ.

PRINCIPAL DISPLAY PANEL - 2.2 mL Tube Carton - ALMOND

PRINCIPAL DISPLAY PANEL - 2.2 mL Tube Carton - OCHER

clé de peau
BEAUTÉ

radiant corrector
for eyes

BROAD SPECTRUM
SPF 28
SUNSCREEN

2.2mL NET WT. .08 OZ.

PRINCIPAL DISPLAY PANEL - 2.2 mL Tube Carton - OCHER

PRINCIPAL DISPLAY PANEL - 2.2 mL Tube Carton - MOCHA

clé de peau
BEAUTÉ

radiant corrector
for eyes

BROAD SPECTRUM
SPF 28
SUNSCREEN

2.2mL NET WT. .08 OZ.

PRINCIPAL DISPLAY PANEL - 2.2 mL Tube Carton - MOCHA

PRINCIPAL DISPLAY PANEL - 2.2 mL Tube Carton - DARK

clé de peau
BEAUTÉ

radiant corrector
for eyes

BROAD SPECTRUM
SPF 28
SUNSCREEN

2.2mL NET WT. .08 OZ.

PRINCIPAL DISPLAY PANEL - 2.2 mL Tube Carton - DARK

CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORY
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-421
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	48 mg in 2.2 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	65 mg in 2.2 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TALC (UNII: 7SEV7J4R1U)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
STANNIC OXIDE (UNII: KM7N50LOS6)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
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:58411-421-60	1 in 1 CARTON	06/01/2018
1		2.2 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	06/01/2018

CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES BEIGE
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-422
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	48 mg in 2.2 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	65 mg in 2.2 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TALC (UNII: 7SEV7J4R1U)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
STANNIC OXIDE (UNII: KM7N50LOS6)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
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:58411-422-60	1 in 1 CARTON	06/01/2018
1		2.2 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	06/01/2018

CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES ALMOND
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-423
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	48 mg in 2.2 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	65 mg in 2.2 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TALC (UNII: 7SEV7J4R1U)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
STANNIC OXIDE (UNII: KM7N50LOS6)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
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:58411-423-60	1 in 1 CARTON	06/01/2018
1		2.2 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	06/01/2018

CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES OCHER
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-424
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	48 mg in 2.2 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	65 mg in 2.2 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TALC (UNII: 7SEV7J4R1U)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
STANNIC OXIDE (UNII: KM7N50LOS6)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
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:58411-424-60	1 in 1 CARTON	06/01/2018
1		2.2 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	06/01/2018

CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES MOCHA
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-425
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	48 mg in 2.2 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	65 mg in 2.2 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TALC (UNII: 7SEV7J4R1U)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
STANNIC OXIDE (UNII: KM7N50LOS6)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
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:58411-425-60	1 in 1 CARTON	06/01/2018
1		2.2 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	06/01/2018

CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES DARK
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-426
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	48 mg in 2.2 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	65 mg in 2.2 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TREHALOSE (UNII: B8WCK70T7I)
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TALC (UNII: 7SEV7J4R1U)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
STANNIC OXIDE (UNII: KM7N50LOS6)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
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:58411-426-60	1 in 1 CARTON	06/01/2018
1		2.2 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	06/01/2018

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Name	Address	ID/FEI	Business Operations
Establishment
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(58411-421, 58411-422, 58411-423, 58411-424, 58411-425, 58411-426) , ANALYSIS(58411-421, 58411-422, 58411-423, 58411-424, 58411-425, 58411-426)

Revised: 5/2018

Document Id: e9246b7c-9e54-4746-b3ac-2c6ab4b1425e

Set id: c4028089-677f-4d51-9c8b-3892ff1649e0

Version: 1

Effective Time: 20180509

SHISEIDO AMERICAS CORPORATION