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

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

Drug Labeling and Warnings

MATTE PRO DEFENSE Base mate con multiproteccion de la piel FPS 20 Matte foundation with skin multiprotection SPF 20 MOKACCINO 390-N by is a Otc medication manufactured, distributed, or labeled by Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

OCTINOXATE 5.00% Sunscreen

ZINC OXIDE 4.20% Sunscreen

PURPOSE

Uses
Helps prevent sunburn.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor ifrash occurs.

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 useon damaged or broken skin.

When using this productkeep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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

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

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

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 emulsion

Product 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 Drug	M020	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)