Label: 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
-
Contains inactivated NDC Code(s)
NDC Code(s): 58411-421-60, 58411-422-60, 58411-423-60, 58411-424-60, view more58411-425-60, 58411-426-60 - Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 9, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
-
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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 2.2 mL Tube Carton - IVORY
- PRINCIPAL DISPLAY PANEL - 2.2 mL Tube Carton - BEIGE
- PRINCIPAL DISPLAY PANEL - 2.2 mL Tube Carton - ALMOND
- PRINCIPAL DISPLAY PANEL - 2.2 mL Tube Carton - OCHER
- PRINCIPAL DISPLAY PANEL - 2.2 mL Tube Carton - MOCHA
- PRINCIPAL DISPLAY PANEL - 2.2 mL Tube Carton - DARK
-
INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORY
octinoxate and titanium dioxide creamProduct 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 creamProduct 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 creamProduct 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 creamProduct 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 creamProduct 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 creamProduct 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)
