Label: STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AZUCAR BLANCA 110-C- octinoxate, zinc oxide cream
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AVELLANA 270-C- octinoxate, zinc oxide cream
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CHOCOTRUFA 430-N- octinoxate, zinc oxide cream
STUDIO LOOK BASE DE ALTA .......0-C- octinoxate, zinc oxide cream
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 ALMENDRA 230-N- octinoxate, zinc oxide cream
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 BROWNIE 380-F- octinoxate, zinc oxide cream
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CARAMELO 210-F- octinoxate, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 43596-0863-1, 43596-0864-1, 43596-0865-1, 43596-0866-1, view more43596-0867-1, 43596-0868-1, 43596-0869-1, 43596-0870-1, 43596-0871-1, 43596-0872-1, 43596-0873-1, 43596-0874-1, 43596-0875-1, 43596-0876-1, 43596-0877-1, 43596-0878-1, 43596-0879-1, 43596-0880-1, 43596-0881-1, 43596-0882-1 - Packager: Ventura Corporation LTD
- 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 July 13, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn not skin cancer or early skin aging.
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove
For external use only - DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Water, Dimethicone, PEG-10 Dimethicone, Glycerin, Isododecane, Polymethysilsesquioxane, Trimethysiloxysilicate, HDI/TRIMETHYLOL Hexyllactone Crosspolymer, PEG/PPG-18/18 Dimethicone, Silica, Lecithin, Silica Dimethyl Silylate, Polypropylsilsesquioxane, Polysilicone-11, Sodium Chloride, Phenoxyethanol, Jojoba Esters, Disteardimonium Hectorite, Tocopheryl Acetate, Dimethicone/Vinyl Dimethicone Crosspolymer, CETYL PEG/PPG-10/1 Dimethicone, POLYGLYCERYL-4 ISOSTEARATE, Helianthus Annuus (Sunflower) Seed Wax, Hexyl Laurate, Caprylyl Glycol, Chlorphenesin, Fragrance, Acacia Deccurens Flower Wax, Polyglycerin-3, Laureth-12, Benzyl Alcohol, Linalool, Hexyl Cinnamal, Limonene.
May Contain: Titanium Dioxide, Iron Oxides, Triethoxycaprylylsilane. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AZUCAR BLANCA 110-C
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0863 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0863-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AVELLANA 270-C
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0873 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0873-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CHOCOTRUFA 430-N
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0881 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0881-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 VAINILLA 140-C
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0865 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) PHENOXYETHANOL (UNII: HIE492ZZ3T) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0865-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 PANELA 320-C
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0876 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0876-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CACAO 350-N
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0878 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0878-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CHANTILLY 130-F
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0864 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0864-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CHOCOCHIP 330-C
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0877 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0877-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 NUEZ 180-F
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0867 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0867-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 TOFFEE 240-C
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0871 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0871-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 ESPRESSO 450-C
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0882 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0882-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 DULCE DE LECHE 260-N
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0872 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0872-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AZUCAR MORENO 300-N
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0875 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0875-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 BOMBON 400-N
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0880 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0880-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CANELA 280-F
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0874 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0874-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AVENA 170-N
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0866 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0866-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 MIEL 200-C
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0868 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0868-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 ALMENDRA 230-N
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0870 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0870-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 BROWNIE 380-F
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0879 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0879-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CARAMELO 210-F
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0869 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.4 g in 100 g Inactive Ingredients Ingredient Name Strength CHLORPHENESIN (UNII: I670DAL4SZ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYL LAURATE (UNII: 4CG9F9W01Q) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) BENZYL ALCOHOL (UNII: LKG8494WBH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LAURETH-12 (UNII: OAH19558U1) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0869-1 30 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations BEL STAR S A 880160197 manufacture(43596-0863, 43596-0864, 43596-0865, 43596-0866, 43596-0867, 43596-0868, 43596-0869, 43596-0870, 43596-0871, 43596-0872, 43596-0873, 43596-0874, 43596-0875, 43596-0876, 43596-0877, 43596-0878, 43596-0879, 43596-0880, 43596-0881, 43596-0882)