LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 - homosalate, octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide lotion 
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 DEFENSE 365 Oil-Free Daily Protective Facial Lotion SPF 50

L'BEL DEFENSE 365 Oil-Free Daily Protective Facial Lotion SPF 50


Active Ingredients

Homosalate (5%)
Octinoxate (7.0%)
Octisalate (5.0%)
Oxybenzone (4.0%)
Titanium Dioxide (6.24%)
Zinc Oxide (3.92%)

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

Aqua (Water), dicaprylyl carbonate, propylheptyl caprylate, glyceryl stearate, potassium cetyl phosphate, alcohol denat., cyclohexasiloxane, polymethylsilsesquioxane, glycerin, sorbitan stearate, bis0ethylhexyl hydroxydimethoxy benzylmalonate, dimethicone, tocopheryl acetate, silica, methicone, peg-8, ceteareth-12, ceteareth-20, propylene glycol, phenoxyethanol, methylparaben, ambrosia peruviana leaf extract, cetearyl alcohol, cetyl palmitate, xanthan gum, caprylyl glycol, mica, propylparaben, butylene glycol, helianthus annuus seed extract (helianthus annuus (sunflower) seed extract), ppg-1-peg-9-lauryl glycol ether, chlorophenesin, triethoxycaprylylsilane, cyclopentasiloxane, hedera helix leaf/stem extract (hedera helix (ivy) leaf/stem extract), phytic acid, sodium polyacrylate.

Purpose

Sunscreen

L'BEL  DEFENSE 365 oil-free protective facial lotion SPF 50   30ml e (1 fl. oz.)

US: Dist. by Ventural Internationa Ltd.  DBA Bellcorp USA, San Francisco, CA 94111

P.R. Dist. by Ventura Corporation Ltd., San Juan, Puerto Rico 00926  MADE IN FRANCE



L'BEL DEFENSE 365 Oil-Free Daily Protective Facial Lotion SPF 50


Defense36530 ml Inner

Defense 36530 ml Outer

LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 
homosalate, octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43455-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.24 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.92 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
ALCOHOL (UNII: 3K9958V90M)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CETEARETH-12 (UNII: 7V4MR24V5P)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
AMBROSIA PERUVIANA LEAF (UNII: 458F79CGBF)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MICA (UNII: V8A1AW0880)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
FYTIC ACID (UNII: 7IGF0S7R8I)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43455-0001-01 mL in 1 POUCH
2NDC:43455-0001-13 mL in 1 TUBE
3NDC:43455-0001-230 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/28/2012
Labeler - Ventura International, LTD (603192787)
Establishment
NameAddressID/FEIBusiness Operations
MF Productions266769145manufacture

Revised: 3/2012
Document Id: c028cd57-f5e6-4dc6-9640-bee5283e1051
Set id: 297ba415-f131-4dd3-9457-ef5382389683
Version: 1
Effective Time: 20120328
 
Ventura International, LTD