LBEL UV DEFENSE 365- homosalate, octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide lotion 
Ventura Corporation Ltd. (San Juan, P.R)

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
UV DÉFENSE 365

Drug Facts

Active IngredientsPurpose
Homosalate (5 %)Sunscreen
Octinoxate (7 %)Sunscreen
Octisalate (5 %)Sunscreen
Oxybenzone (4 %)Sunscreen
Titanium Dioxide (6.24%)Sunscreen
Zinc Oxide (3.88%)Sunscreen

Uses

  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection

Warnings

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

  • Stop use and ask a doctor if rash and irritation develops and lasts.

  • 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, bis-ethylhexyl hydroxydimethoxy benzylmalonate, dimethicone, tocopheryl acetate, ceteareth-20, silica, methicone, cetearyl alcohol, ceteareth-12, cetyl palmitate, peg-8, propylene glycol, phenoxyethanol, methylparaben, ambrosia peruviana leaf extract, xantham gum, caprylyl glycol, mica, propylparaben, triethoxycaprylylsilane, butylene glycol, helianthus annuus (sunflower) seed extract, ppg-1-peg-9-lauryl glycol ether, chlorphenesin, cyclopentasiloxane, hedera helix (ivy) leaf/stem extract, phytic acid, sodium polyacrylate.

Dist. by Ventura Corporation, Ltd, San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

L'BEL

UV DÉFENSE 365

oil-free daily protective
facial lotion SPF 50

UVB SPF 50
UVA PA +++

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Carton
LBEL UV DEFENSE 365 
homosalate, octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate0.05 g  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.04 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.0624 g  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.0388 g  in 1 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)  
cyclomethicone 6 (UNII: XHK3U310BA)  
glycerin (UNII: PDC6A3C0OX)  
sorbitan monostearate (UNII: NVZ4I0H58X)  
dimethicone (UNII: 92RU3N3Y1O)  
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
ceteareth-12 (UNII: 7V4MR24V5P)  
cetyl palmitate (UNII: 5ZA2S6B08X)  
polyethylene glycol 400 (UNII: B697894SGQ)  
propylene glycol (UNII: 6DC9Q167V3)  
phenoxyethanol (UNII: HIE492ZZ3T)  
methylparaben (UNII: A2I8C7HI9T)  
ambrosia peruviana leaf (UNII: 458F79CGBF)  
xanthan gum (UNII: TTV12P4NEE)  
caprylyl glycol (UNII: 00YIU5438U)  
mica (UNII: V8A1AW0880)  
propylparaben (UNII: Z8IX2SC1OH)  
triethoxycaprylylsilane (UNII: LDC331P08E)  
butylene glycol (UNII: 3XUS85K0RA)  
sunflower seed (UNII: R9N3379M4Z)  
chlorphenesin (UNII: I670DAL4SZ)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
hedera helix top (UNII: 379040L9FW)  
phytic acid (UNII: 7IGF0S7R8I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-402-021 in 1 BOX
1NDC:13537-402-0130 mL in 1 BOTTLE
2NDC:13537-402-041 in 1 BOX
2NDC:13537-402-033 mL in 1 BOTTLE
3NDC:13537-402-051 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/29/2011
Labeler - Ventura Corporation Ltd. (San Juan, P.R) (602751344)
Establishment
NameAddressID/FEIBusiness Operations
MF Productions Saumur266769145MANUFACTURE

Revised: 8/2011
Document Id: 38b1a1b0-a33d-404c-8214-b9cbf57a478c
Set id: 0873d6a1-55df-415e-8f95-2d08ef7ee84f
Version: 1
Effective Time: 20110825
 
Ventura Corporation Ltd. (San Juan, P.R)