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 
Bel Star S.A. (Colombia)

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.

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MATTE PRO DEFENSE Base mate con multiproteccion de la piel FPS 20 Matte foundation with skin multiprotection SPF 20 MOKACCINO 390-N

Active Ingredients Purpose

OCTINOXATE 7.20 Sunscreen

ZINC OXIDE 7.00 Sunscreen

Uses
Helps prevent sunburn.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs.

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.

Directions

Apply liberally and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating.
Children under 6 months of age: Ask a doctor

Other information
Protect the product in this container from excessive heat and direct sun.

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

L'BEL

MATTE PRO DEFENSE
Base Mate con multiproteccion de la piel FPS 20
Matte foundation with skin multiprotection SPF 20
1.01 fl. oz. (30ml)
Tone MOKACCINO 390-N

Mokaccino 390-N

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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-226
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14141-226-0130 mL in 1 JAR; Type 0: Not a Combination Product04/14/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/14/2021
Labeler - Bel Star S.A. (Colombia) (880160197)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(14141-226)

Revised: 4/2021
Document Id: c08524ec-438d-0f0d-e053-2a95a90adb9c
Set id: c0852486-f83d-7fd1-e053-2995a90a321d
Version: 1
Effective Time: 20210414
 
Bel Star S.A. (Colombia)