Label: MATTE PRO DEFENSE BASE MATE CON MULTIPROTECCION DE LA PIEL FPS 20 MATTE FOUNDATION WITH SKIN MULTIPROTECTION SPF 20 MOKACCINO 390-N- zinc oxide,octinoxate emulsion
- NDC Code(s): 14141-226-01
- Packager: Bel Star S.A. (Colombia)
- 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 April 30, 2021
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- 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.
For external use only.
Do not use on damaged or broken skin.When using this product keep out of eyes. Rinse with water to remove.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients: WATER, DIMETHICONE, ISODODECANE, PEG-10 DIMETHICONE, TRIMETHYLSILOXYSILICATE, PROPYLENE GLYCOL, MICA, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG/PPG-18/18 DIMETHICONE, POLYSILICONE-11, GLYCERIN, LECITHIN, SODIUM CHLORIDE, PHENOXYETHANOL, SILICA, SILICA DIMETHYL SILYLATE, BACKHOUSIA CITRIODORA LEAF EXTRACT, MALTODEXTRIN, CAPRYLYL GLYCOL, DISTEARDIMONIUM HECTORITE, HYDROXYETHYL UREA, PEG-8 CAPRYLIC/CAPRIC GLYCERIDES, CHLORPHENESIN, TOCOPHERYL ACETATE, LACTOBACILLUS FERMENT, OCTYLDODECETH-25, PERFLUOROOCTYL TRIETHOXYSILANE, SODIUM HYALURONATE, DECYLENE GLYCOL.
MAY CONTAIN :
TITANIUM DIOXIDE, IRON OXIDES, TRIETHOXYCAPRYLYLSILANE. - 390-N
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INGREDIENTS AND APPEARANCE
MATTE PRO DEFENSE BASE MATE CON MULTIPROTECCION DE LA PIEL FPS 20 MATTE FOUNDATION WITH SKIN MULTIPROTECTION SPF 20 MOKACCINO 390-N
zinc oxide,octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14141-226 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4.2 g in 100 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ISODODECANE (UNII: A8289P68Y2) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CAPRYLYL GLYCOL (UNII: 00YIU5438U) LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) DECYLENE GLYCOL (UNII: S57M60MI88) HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) CHLORPHENESIN (UNII: I670DAL4SZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) MALTODEXTRIN (UNII: 7CVR7L4A2D) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MICA (UNII: V8A1AW0880) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) OCTYLDODECETH-25 (UNII: F8934HEL3M) GLYCERIN (UNII: PDC6A3C0OX) PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2) DIMETHICONE (UNII: 92RU3N3Y1O) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747) PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14141-226-01 30 mL in 1 JAR; Type 0: Not a Combination Product 04/14/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/14/2021 Labeler - Bel Star S.A. (Colombia) (880160197) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 manufacture(14141-226)