NDC | 13537-489-01, 13537-571-01, 13537-572-01, 13537-573-01, 13537-574-01, 13537-575-01, 13537-576-01 |
Set ID | bde43570-e87e-451b-aae3-6b5123f8b670 |
Category | HUMAN OTC DRUG LABEL |
Packager | Ventura Corporation LTD |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
-
Inactive ingredients
WATER, DIMETHICONE, PEG-10 DIMETHICONE, SILICA, GLYCERIN, POLYMETHYLSILSESQUIOXANE, ISODODECANE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIMETHYLSILOXYSILICATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, SILICA DIMETHYL SILYLATE, POLYPROPYLSILSESQUIOXANE, HYDROXYACETOPHENONE, PHENOXYETHANOL, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, JOJOBA ESTERS, HEXYL LAURATE, SODIUM CHLORIDE, TOCOPHERYL ACETATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX, DISTEARDIMONIUM HECTORITE, CAPRYLYL GLYCOL, CHLORPHENESIN, POLYSILICONE-11, FRAGRANCE, ACACIA DECURRENS FLOWER WAX, POLYGLYCERIN-3.
MAY CONTAIN:
TITANIUM DIOXIDE, IRON OXIDES, TRIETHOXYCAPRYLYLSILANE. - SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box (LIGHT 1) - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box (LIGHT 2) - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box (MEDIUM 1) - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box (MEDIUM 2) - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box (MEDIUM 3) - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box (MEDIUM 4) - BROWN
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box (OBSCURE 1) - BROWN
-
INGREDIENTS AND APPEARANCE
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 (LIGHT 1) - BEIGE
octinoxate and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-489 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.04 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.024 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) ISODODECANE (UNII: A8289P68Y2) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) SODIUM CHLORIDE (UNII: 451W47IQ8X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-489-01 1 in 1 BOX 1 30 g in 1 TUBE; 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 08/26/2015 CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 (LIGHT 2) - BEIGE
octinoxate and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-571 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.04 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.024 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) ISODODECANE (UNII: A8289P68Y2) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) SODIUM CHLORIDE (UNII: 451W47IQ8X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-571-01 1 in 1 BOX 1 30 g in 1 TUBE; 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 08/26/2015 CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 (MEDIUM 1) - BEIGE
octinoxate and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-572 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.04 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.024 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) ISODODECANE (UNII: A8289P68Y2) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) SODIUM CHLORIDE (UNII: 451W47IQ8X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-572-01 1 in 1 BOX 1 30 g in 1 TUBE; 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 08/26/2015 CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 (MEDIUM 2) - BEIGE
octinoxate and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-573 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.04 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.024 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) ISODODECANE (UNII: A8289P68Y2) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) SODIUM CHLORIDE (UNII: 451W47IQ8X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-573-01 1 in 1 BOX 1 30 g in 1 TUBE; 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 08/26/2015 CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 (MEDIUM 3) - BEIGE
octinoxate and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-574 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.04 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.024 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) ISODODECANE (UNII: A8289P68Y2) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) SODIUM CHLORIDE (UNII: 451W47IQ8X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-574-01 1 in 1 BOX 1 30 g in 1 TUBE; 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 08/26/2015 CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 (MEDIUM 4) - BROWN
octinoxate and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-575 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.04 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.024 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) ISODODECANE (UNII: A8289P68Y2) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) SODIUM CHLORIDE (UNII: 451W47IQ8X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-575-01 1 in 1 BOX 1 30 g in 1 TUBE; 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 08/26/2015 CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 (OBSCURE 1) - BROWN
octinoxate and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-576 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.04 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.024 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) ISODODECANE (UNII: A8289P68Y2) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) SODIUM CHLORIDE (UNII: 451W47IQ8X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-576-01 1 in 1 BOX 1 30 g in 1 TUBE; 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 08/26/2015 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-489, 13537-571, 13537-572, 13537-573, 13537-574, 13537-575, 13537-576)