LBEL LEDERM 55PLUS JOUR  SPF 15 FACIAL TREATMENT AGAINST ADVANCED SIGNS OF AGING DAY - ALL SKIN TYPES- avobenzone, octisalate, octocrylene, and oxybenzone cream 
Ventura Corporation 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 LEDERM 55plus Jour
SPF 15 Facial Treatment Against Advanced Signs of Aging Day - All Skin Types

Drug Facts

Active Ingredients Purpose
AVOBENZONE 3.0%Sunscreen
OCTISALATE 5.0%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
OXYBENZONE 5.0%Sunscreen

Uses

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.

  • 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), GLYCERIN, C12-15 ALKYL BENZOATE, DIMETHICONE, DICAPRYLYL CARBONATE, PHENETHYL BENZOATE, CYCLOPENTASILOXANE, POTASSIUM CETYL PHOSPHATE, CETEARYL ALCOHOL, CYCLOHEXASILOXANE, PENTYLENE GLYCOL, TRILAURETH-4 PHOSPHATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROGENATED PALM GLYCERIDES, METHYL METHACRYLATE CROSSPOLYMER, PHENOXYETHANOL, CETYL ALCOHOL, GLYCERYL STEARATE, ALBIZIA JULIBRISSIN BARK EXTRACT, BIS-VINYL DIMETHICONE/DIMETHICONE COPOLYMER, PEG-75 STEARATE, XANTHAN GUM, CETEARETH-20, CHLORPHENESIN, PARFUM (FRAGRANCE), ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CETETH-20, STEARETH-20, TETRASODIUM EDTA, ACACIA SENEGAL GUM, CICHORIUM INTYBUS ROOT EXTRACT (CICHORIUM INTYBUS (CHICORY) ROOT EXTRACT), ALARIA ESCULENTA EXTRACT, SODIUM HYDROXIDE, ALCOHOL, LECITHIN, HYDROLYZED SOYBEAN FIBER, HYDROXYPROPYL CYCLODEXTRIN, FOLIC ACID, HYDROLYZED CORN PROTEIN, PALMITOYL TRIPEPTIDE-38

P.R.: Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 50 g Bottle Carton

L'BEL
LEDERM

• FORMULA CREATED BY FRNECH DERMATOLOGISTS
SKIN
EXPERTS

55+ JOUR

facial treatment
against advanced
signs of aging
day cream SPF 15
all skin types

50 g e (1.7 oz.)

Principal Display Panel - 50 g Bottle Carton
LBEL LEDERM 55PLUS JOUR   SPF 15 FACIAL TREATMENT AGAINST ADVANCED SIGNS OF AGING DAY - ALL SKIN TYPES
avobenzone, octisalate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-448
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.03 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.05 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
PEG-75 STEARATE (UNII: OT38R0N74H)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CETETH-20 (UNII: I835H2IHHX)  
STEARETH-20 (UNII: L0Q8IK9E08)  
EDETATE SODIUM (UNII: MP1J8420LU)  
ACACIA (UNII: 5C5403N26O)  
CHICORY ROOT (UNII: 090CTY533N)  
ALARIA ESCULENTA (UNII: EJ9JK8J58D)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ALCOHOL (UNII: 3K9958V90M)  
FOLIC ACID (UNII: 935E97BOY8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-448-011 g in 1 PACKET
2NDC:13537-448-041 in 1 BOX
2NDC:13537-448-035 g in 1 BOTTLE, PLASTIC
3NDC:13537-448-061 in 1 BOX
3NDC:13537-448-0550 g in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/01/2013
Labeler - Ventura Corporation LTD. (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-448)
Establishment
NameAddressID/FEIBusiness Operations
Yobel Supply Chain Management S.A. (Peru)934116930MANUFACTURE(13537-448)

Revised: 4/2013
Document Id: 4b1995b6-09c5-4828-8f20-3d972ca007d0
Set id: 96fcecbc-d5d9-485d-bdfc-bd6eff05ff3d
Version: 1
Effective Time: 20130401
 
Ventura Corporation LTD.