Label: DECORTE SHEER BRILLIANCE 10- octinoxate, zinc oxide lotion
DECORTE SHEER BRILLIANCE 20- octinoxate, zinc oxide lotion
DECORTE SHEER BRILLIANCE 30- octinoxate, zinc oxide lotion
DECORTE SHEER BRILLIANCE 40- octinoxate, zinc oxide lotion
- NDC Code(s): 66820-0110-1, 66820-0120-1, 66820-0130-1, 66820-0140-1
- Packager: KOSE AMERICA, INC.
- 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 January 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
- Warnings
-
Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
-
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-sleeved shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
-
Inactive ingredients:
WATER (AQUA) •CYCLOMETHICONE •ALCOHOL •LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE •ISOTRIDECYL ISONONAOATE •TRIMETHYLSILOXYSILICATE •PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE •TRIETHYLHEXANOIN •ACORUS CALAMUS ROOT EXTRACT •ALGAE OLIGOSACCHARIDES •ASTAXANTHIN •EUGENIA CARYOPHYLLUS (CLOVE) FLOWER EXTRACT •HAEMATOCOCCUS PLUVIALIS EXTRACT •PALMITOYL PENTAPEPTIDE-4 •RHODIOLA SACRA ROOT EXTRACT •SOLUBLE COLLAGEN •TOCOPHEROL •ZIZYPHUS JUJUBA FRUIT EXTRACT •ALGIN •ALUMINUM HYDROXIDE •BHT •BUTYLENE GLYCOL •CAPRYLIC/CAPRICTRIGLYCERIDE •CARBOMER •CELLULOSE •DIMETHECONE/VINYL DIMETHICONE CROSSPOLYMER •DISTEAR DIMONIUM HECTORITE •GLYCERIN •HYDROGEN DIMETHICONE •HYDROGENATED LECITHIN •ISOPROPYL TITANIUM TRIISOSTEARATE •PHYTOSTERYL OLEATE •POLYSORBATE 20 •SODIUM CHLORIDE •SODIUM LACTATE •SQUALANE •TRIETHOXYCAPRYLYLSILANE •PHENOXYETHANOL •FRAGRANCE (PARFUM) •MAY CONTAIN (+/-): IRON OXIDES (CI 77491) •IRON OXIDES (CI 77492) •IRON OXIDES (CI 77499) •MICA •TITANIUM DIOXIDE (CI 77891)
- Other information
- Principal Display Panel - Decorte Sheet Brilliance 10 Level 50 ml Carton Label
- Principal Display Panel - Decorte Sheet Brilliance 20 Level 50 ml Carton Label
- Principal Display Panel - Decorte Sheet Brilliance 30 Level 50 ml Carton Label
- Principal Display Panel - Decorte Sheet Brilliance 40 Level 50 ml Carton Label
-
INGREDIENTS AND APPEARANCE
DECORTE SHEER BRILLIANCE 10
octinoxate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66820-0110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.9 g in 50 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3.8 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) ALCOHOL (UNII: 3K9958V90M) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F) HYDROLYZED GELIDIUM ELEGANS POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: M91AS4K4UK) HYDROLYZED GELIDIUM LINGULATUM POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: 12SMS2KQK5) HYDROLYZED GELIDIUM REX POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: 1R4EEP8DYW) HYDROLYZED GELIDIUM SESQUIPEDALE POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: UVZ8S1689C) HYDROLYZED GRACILARIA CHILENSIS POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: K8A98IM6B4) HYDROLYZED GRACILARIA VERMICULOPHYLLA POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: 3FDS8YD26E) HYDROLYZED PTEROCLADIELLA TENUIS POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: LK2Q17N3NI) ASTAXANTHIN (UNII: 8XPW32PR7I) CLOVE (UNII: K48IKT5321) HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) RHODIOLA SACRA ROOT (UNII: 11R149C3CY) MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W) TOCOPHEROL (UNII: R0ZB2556P8) JUJUBE FRUIT (UNII: G55HNL2C70) SODIUM ALGINATE (UNII: C269C4G2ZQ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) POWDERED CELLULOSE (UNII: SMD1X3XO9M) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) HYDROLYZED ORYZANOL OLEATES (UNII: CZ7DW0L6FX) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM LACTATE (UNII: TU7HW0W0QT) SQUALANE (UNII: GW89575KF9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66820-0110-1 1 in 1 CARTON 05/01/2018 1 50 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 final part352 05/01/2018 DECORTE SHEER BRILLIANCE 20
octinoxate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66820-0120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.9 g in 50 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3.8 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) ALCOHOL (UNII: 3K9958V90M) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F) HYDROLYZED GELIDIUM ELEGANS POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: M91AS4K4UK) HYDROLYZED GELIDIUM LINGULATUM POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: 12SMS2KQK5) HYDROLYZED GELIDIUM REX POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: 1R4EEP8DYW) HYDROLYZED GELIDIUM SESQUIPEDALE POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: UVZ8S1689C) HYDROLYZED GRACILARIA CHILENSIS POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: K8A98IM6B4) HYDROLYZED GRACILARIA VERMICULOPHYLLA POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: 3FDS8YD26E) HYDROLYZED PTEROCLADIELLA TENUIS POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: LK2Q17N3NI) ASTAXANTHIN (UNII: 8XPW32PR7I) CLOVE (UNII: K48IKT5321) HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) RHODIOLA SACRA ROOT (UNII: 11R149C3CY) MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W) TOCOPHEROL (UNII: R0ZB2556P8) JUJUBE FRUIT (UNII: G55HNL2C70) SODIUM ALGINATE (UNII: C269C4G2ZQ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) POWDERED CELLULOSE (UNII: SMD1X3XO9M) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) HYDROLYZED ORYZANOL OLEATES (UNII: CZ7DW0L6FX) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM LACTATE (UNII: TU7HW0W0QT) SQUALANE (UNII: GW89575KF9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66820-0120-1 1 in 1 CARTON 05/01/2018 1 50 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 final part352 05/01/2018 DECORTE SHEER BRILLIANCE 30
octinoxate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66820-0130 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.9 g in 50 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3.8 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) ALCOHOL (UNII: 3K9958V90M) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F) HYDROLYZED GELIDIUM ELEGANS POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: M91AS4K4UK) HYDROLYZED GELIDIUM LINGULATUM POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: 12SMS2KQK5) HYDROLYZED GELIDIUM REX POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: 1R4EEP8DYW) HYDROLYZED GELIDIUM SESQUIPEDALE POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: UVZ8S1689C) HYDROLYZED GRACILARIA CHILENSIS POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: K8A98IM6B4) HYDROLYZED GRACILARIA VERMICULOPHYLLA POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: 3FDS8YD26E) HYDROLYZED PTEROCLADIELLA TENUIS POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: LK2Q17N3NI) ASTAXANTHIN (UNII: 8XPW32PR7I) CLOVE (UNII: K48IKT5321) HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) RHODIOLA SACRA ROOT (UNII: 11R149C3CY) MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W) TOCOPHEROL (UNII: R0ZB2556P8) JUJUBE FRUIT (UNII: G55HNL2C70) SODIUM ALGINATE (UNII: C269C4G2ZQ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) POWDERED CELLULOSE (UNII: SMD1X3XO9M) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) HYDROLYZED ORYZANOL OLEATES (UNII: CZ7DW0L6FX) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM LACTATE (UNII: TU7HW0W0QT) SQUALANE (UNII: GW89575KF9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66820-0130-1 1 in 1 CARTON 05/01/2018 1 50 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 final part352 05/01/2018 DECORTE SHEER BRILLIANCE 40
octinoxate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66820-0140 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.9 g in 50 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3.8 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) ALCOHOL (UNII: 3K9958V90M) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F) HYDROLYZED GELIDIUM ELEGANS POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: M91AS4K4UK) HYDROLYZED GELIDIUM LINGULATUM POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: 12SMS2KQK5) HYDROLYZED GELIDIUM REX POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: 1R4EEP8DYW) HYDROLYZED GELIDIUM SESQUIPEDALE POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: UVZ8S1689C) HYDROLYZED GRACILARIA CHILENSIS POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: K8A98IM6B4) HYDROLYZED GRACILARIA VERMICULOPHYLLA POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: 3FDS8YD26E) HYDROLYZED PTEROCLADIELLA TENUIS POLYSACCHARIDES (ENZYMATIC; 750 MW) (UNII: LK2Q17N3NI) ASTAXANTHIN (UNII: 8XPW32PR7I) CLOVE (UNII: K48IKT5321) HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) RHODIOLA SACRA ROOT (UNII: 11R149C3CY) MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W) TOCOPHEROL (UNII: R0ZB2556P8) JUJUBE FRUIT (UNII: G55HNL2C70) SODIUM ALGINATE (UNII: C269C4G2ZQ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) POWDERED CELLULOSE (UNII: SMD1X3XO9M) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) HYDROLYZED ORYZANOL OLEATES (UNII: CZ7DW0L6FX) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM LACTATE (UNII: TU7HW0W0QT) SQUALANE (UNII: GW89575KF9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66820-0140-1 1 in 1 CARTON 05/01/2018 1 50 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 final part352 05/01/2018 Labeler - KOSE AMERICA, INC. (080407621)