LBEL LEDERM 45 PLUS JOUR FACIAL AGAINST NOTICEABLE SIGNS OF AGING- avobenzone, octisalate, octocrylene, and oxybenzone lotion 
Bel Star S.A. (Colombia)

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 45 + JOUR Facial lotion against noticeable signs of aging

Drug Facts

Active IngredientsPurpose
Avobenzone 3%Sunscreen
Octisalate 5%Sunscreen
Octocrylene 3%Sunscreen
Oxybenzone 5%Sunscreen

Uses

  • Helps prevent sunburn.

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

  • 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, c12-15 alkyl benzoate, cyclohexasiloxane, glycerin, potassium cetyl phosphate, albizia julibrissin bark extract, dimethicone, glyceryl stearate, pentylene glycol, methyl methacrylate crosspolymer, hydrogenated palm glycerides, phenoxyethanol, xanthan gum, c20-22 alkyl phosphate, acrylates/vinyl isodecanoate crosspolymer, fragrance, c20-22 alcohols, chlorphenesin, hydrolyzed ceratonia siliqua seed extract, sodium hydroxide, acacia senegal gum, disodium edta, olive oil aminopropanediol esters, raspberry seed oil/tocopheryl succinate aminopropanediol esters, hydroxypropyl cyclodextrin, palmitoyl tripeptide-38.

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

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box

• FORMULA CREATED BY FRENCH DERMATOLOGISTS
SKIN
EXPERTS

LEDERM

45+  JOUR

facial lotion
against noticeable
signs of aging
day lotion SPF 15
all skin types

50 ml e (1.6 fl.oz.)

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
LBEL LEDERM 45 PLUS JOUR FACIAL AGAINST NOTICEABLE SIGNS OF AGING 
avobenzone, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-994
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.03 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)  
C20-22 ALCOHOLS (UNII: O4M0347C6A)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ACACIA (UNII: 5C5403N26O)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14141-994-021 in 1 BOX10/24/2016
1NDC:14141-994-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/24/201607/09/2023
Labeler - Bel Star S.A. (Colombia) (880160197)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(14141-994)

Revised: 12/2022
Document Id: ef55550d-703a-c7d2-e053-2a95a90a3364
Set id: f0922272-b519-477f-bf63-22bf11005f85
Version: 2
Effective Time: 20221208
 
Bel Star S.A. (Colombia)