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

CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
OCTINOXATE 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

WATERDIMETHICONEBUTYLENE GLYCOLGLYCERINDIISOSTEARYL MALATEPEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEPEG-10 DIMETHICONESORBITAN SESQUIISOSTEARATETRIMETHYLSILOXYSILICATEDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMERTREHALOSECRATAEGUS MONOGYNA FLOWER EXTRACTSODIUM ACETYLATED HYALURONATEZINGIBER AROMATICUS EXTRACTPEG/PPG-14/7 DIMETHYL ETHERROSA ROXBURGHII FRUIT EXTRACTPOLYQUATERNIUM-51HYDROLYZED CONCHIOLIN PROTEINHYDROLYZED SILKCAPRYLYL METHICONEALUMINUM HYDROXIDEDISTEARDIMONIUM HECTORITEPOLYSILICONE-2STEARIC ACIDTRISODIUM EDTASODIUM CITRATEBHTALCOHOLCITRIC ACIDTOCOPHEROLTALCSODIUM METABISULFITEHYDROGEN DIMETHICONETIN OXIDETHEANINEPHENOXYETHANOLMETHYLPARABENETHYLPARABENFRAGRANCETITANIUM DIOXIDEIRON OXIDESMICA

Other information

• protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 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 - 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 - 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 - 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 - 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 - DARK

clé de peau
BEAUTÉ

radiant corrector
for eyes

BROAD SPECTRUM
SPF 28
SUNSCREEN

2.2mL NET WT. .08 OZ.

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	06/01/2018

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
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)