NDC | 43596-0061-1, 43596-0061-2 |
Set ID | 2e9fe1d0-810e-480b-aabc-67f863adf60e |
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
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Inactive ingredients
DIMETHICONE, WATER, PEG-10 DIMETHICONE, PROPYLENE GLYCOL, POLYMETHYLSILSESQUIOXANE, PEG/PPG-18/18 DIMETHICONE, SILICA, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PHENOXYETHANOL, HYDROXYACETOPHENONE, POLYSILICONE-11, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, SODIUM CHLORIDE, GLYCERIN, HEXYL LAURATE, CAPRYLYL GLYCOL, CHLORPHENESIN, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, COCOS NUCIFERA (COCONUT) OIL, COCOS NUCIFERA (COCONUT) FRUIT EXTRACT, PEG-60 HYDROGENATED CASTOR OIL, AVENA SATIVA (OAT) KERNEL EXTRACT, PHENETHYL ALCOHOL, POTASSIUM SORBATE, SODIUM BENZOATE, HELIANTHUS ANNUUS (SUNFLOWER) EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT.
MAY CONTAIN:
TITANIUM DIOXIDE, IRON OXIDES. - SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 25 g Tube Box
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INGREDIENTS AND APPEARANCE
CY GO NUDE BASE LIGERA ACABO NATURAL COBERTURA MEDIA FPS 20
octinoxate and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0061 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.06 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.06 g in 1 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) HEXYL LAURATE (UNII: 4CG9F9W01Q) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) COCONUT OIL (UNII: Q9L0O73W7L) COCONUT (UNII: 3RT3536DHY) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) OAT (UNII: Z6J799EAJK) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) ROSEMARY (UNII: IJ67X351P9) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0061-2 1 in 1 BOX 04/19/2017 1 NDC:43596-0061-1 25 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 04/19/2017 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(43596-0061)