LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octisalate, octocrylene, and oxybenzone 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 LEDERM DAY LOTION SUNSCREEN BROAD SPECTRUM SPF 15

Drug Facts

Active IngredientsPurpose
AVOBENZONE 3.0%Sunscreen
OCTISALATE 5.0 %Sunscreen
OCTOCRYLENE 3.0 %Sunscreen
OXYBENZONE 5.0 %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

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.

USA: Dist. by Ventura International Ltd. DBA Belcorp USA,
San Francisco, CA 94111.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Box

• FORMULATED BY FRENCH DERMATOLOGISTS
SKIN
EXPERTS

LEDERM

DAY LOTION

SUNSCREEN
BROAD SPECTRUM
SPF 15

day facial lotion
SPF 15 against
noticeable signs
of aging
normal to oily skin

50 ml e (1.6 fl.oz.)

Principal Display Panel - 50 mL Bottle Box
LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 
avobenzone, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-803
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 (UNII: 7FLD91C86K)  
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-803-021 in 1 BOX
1NDC:14783-803-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35206/22/2015
Labeler - Ventura International LTD (603192787)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(14783-803)

Revised: 6/2015
Document Id: 912ed4b3-0ad8-4c41-8020-469e753ab147
Set id: f109db6d-ae49-4e18-ab1c-c79c0de2413a
Version: 1
Effective Time: 20150622
 
Ventura International LTD