LBEL DEFENSE TOTAL COMPACT SUNCREEN SPF 50 FOR FACE - MATTE FINISH- octinoxate, octocrylene, and zinc oxide cream 
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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L'BEL Défense Total Compact Cream Suncreen SPF 50 For Face - Matte Finish

Drug Facts

Active Ingredients Purpose
OCTINOXATE 7%Sunscreen
OCTOCRYLENE 5%Sunscreen
ZINC OXIDE 16.66%Sunscreen

Uses

Warnings

  • Do not use on damaged or broken skin.

  • When using this product keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor if rash occurs.

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

Directions

Other information

Inactive ingredients

DIMETHICONE, ZEA MAYS (CORN) STARCH, POLYMETHYLSILSESQUIOXANE, POLYETHYLENE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, MICA, OZOKERITE, BUTYROSPERMUM PARKII (SHEA) BUTTER, SORBITAN SESQUIOLEATE, PEG/PPG-18/18 DIMETHICONE, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, DIISOPROPYL ADIPATE, COPERNICIA CERIFERA (CARNAUBA) WAX, TOCOPHERYL ACETATE, CERAMIDE 3, CAPRYLYL GLYCOL, CHLORPHENESIN, PHYSALIS ANGULATA EXTRACT, FRAGRANCE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SILICA, TRIMETHYLSILOXYSILICATE, OXOTHIAZOLIDINE, LINALOOL.
MAY CONTAIN: TITANIUM DIOXIDE, IRON OXIDES.

Dist. by Ventura Int
Ltd. DBA Belcorp USA, Miami,
FL 33126.

PRINCIPAL DISPLAY PANEL - 9,5 g Container Box

MEDIUM

L'BEL
DÉFENSETOTAL

HIGH PROTECTION
SPF
50

compact cream sunscreen
for face - matte finish

BROAD SPECTRUM
WATER RESISTANT (40 minutes)

Net Wt. 0.34 oz. e (9,5 g)

PRINCIPAL DISPLAY PANEL - 9,5 g Container Box
LBEL DEFENSE TOTAL COMPACT SUNCREEN SPF 50 FOR FACE - MATTE FINISH 
octinoxate, octocrylene, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.05 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.1666 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
MICA (UNII: V8A1AW0880)  
CERESIN (UNII: Q1LS2UJO3A)  
SHEA BUTTER (UNII: K49155WL9Y)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CERAMIDE NP (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
OXOTHIAZOLIDINE (UNII: M6U1ZG59XD)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-111-021 in 1 BOX04/18/2017
1NDC:14783-111-019.5 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/18/2017
Labeler - Ventura International LTD (603192787)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(14783-111)

Revised: 6/2017
Document Id: 283abfd8-e454-4848-af01-0b9224b4a2bf
Set id: 6329d5fb-8a97-4a18-8152-91d2c0bf48f9
Version: 2
Effective Time: 20170612
 
Ventura International LTD