CONCENTRE TOTAL BASE SERUM BASE DE MAQUILLAJE ULTRA-FLUID FOUNDATION SPF 25 MOKACCINO 390-N- zinc oxide,octinoxate emulsion 
Ventura International LTD

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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CONCENTRÉ TOTAL BASE SÉRUM BASE DE MAQUILLAJE ULTRA-FLUID FOUNDATION SPF 25 MOKACCINO 390-N

Active Ingredients Purpose
ZINC OXIDE 7.20 % Sunscreen
OCTINOXATE 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, Cyclohexasiloxane, Nylon-12, Isododecane, Glycerin, HDI/Trimethylol Hexyllactone Crosspolymer, PEG-10 Dimethicone Alcohol Denat., Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Albizia Julibrissin Bark Extract, Cyclopentasiloxane, Phenoxyethanol, Silica, Polyglyceryl-4 Isostearate, Lectithin, Tocopheryl Acetate, Hexyl Laurate, Methylpropanediol, Disteardimonium Hectorite, Caprylyl Glycol, Chlorphenesin, Silanediol Salicylate, Tromethamine, Ceramide NP, Grifola Frondosa Fruiting Body Extract, Fragrance, Maltodextrin, Linalool, Limonene, Alpha-Isomethyl Ionone. May Contain: Titanium Dioxide, Iron Oxides, Triethoxycaprylylsilane

390-N

L'BEL

Concentre Total

Base Serum

base de maquillaje ultrafluida FPS 25

ultra-fluid foundation SPF 25

0.87 fl. oz. (26ml)

Mokaccino

CONCENTRE TOTAL BASE SERUM BASE DE MAQUILLAJE ULTRA-FLUID FOUNDATION SPF 25 MOKACCINO 390-N 
zinc oxide,octinoxate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-286
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CERAMIDE NP (UNII: 4370DF050B)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MAITAKE (UNII: A1U5YJI0Z8)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
NYLON-12 (UNII: 446U8J075B)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TROMETHAMINE (UNII: 023C2WHX2V)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALCOHOL (UNII: 3K9958V90M)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-286-0126 mL in 1 JAR; Type 0: Not a Combination Product03/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/05/2021
Labeler - Ventura International LTD (603192787)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(14783-286)

Revised: 4/2021
Document Id: c0801dc5-308b-dd31-e053-2995a90a50a1
Set id: c0801dc5-308a-dd31-e053-2995a90a50a1
Version: 1
Effective Time: 20210421
 
Ventura International LTD