Label: LBEL LEDERM 45PLUS JOUR SPF 15 FACIAL TREATMENT AGAINST NOTICEABLE SIGNS OF AGING DAY - NORMAL TO DRY SKIN- avobenzone, octisalate, octocrylene, and oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-447-01, 13537-447-03, 13537-447-04, 13537-447-05, view more13537-447-06 - Packager: Ventura Corporation LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 2, 2013
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
AQUA (WATER), C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, GLYCERIN, DIMETHICONE, POTASSIUM CETYL PHOSPHATE, ALBIZIA JULIBRISSIN BARK EXTRACT, BUTYLENE GLYCOL, GLYCERYL STEARATE, PENTYLENE GLYCOL, HYDROGENATED PALM GLYCERIDES, PHENOXYETHANOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, XANTHAN GUM, C20-22 ALKYL PHOSPHATE, ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER, PARFUM (FRAGRANCE), C20-22 ALCOHOLS, CHLORPHENESIN, HYDROLYZED CERATONIA SILIQUA SEED EXTRACT, ACACIA SENEGAL GUM, SODIUM HYDROXIDE, DISODIUM EDTA, OLIVE OIL AMINOPROPANEDIOL ESTERS, RASPBERRY SEED OIL/TOCOPHERYL SUCCINATE AMINOPROPANEDIOL ESTERS, HYDROXYPROPYL CYCLODEXTRIN, SILICA, PALMITOYL TRIPEPTIDE-38
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 g Bottle Carton
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INGREDIENTS AND APPEARANCE
LBEL LEDERM 45PLUS JOUR SPF 15 FACIAL TREATMENT AGAINST NOTICEABLE SIGNS OF AGING DAY - NORMAL TO DRY SKIN
avobenzone, octisalate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-447 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.03 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.05 g in 1 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.03 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.05 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CYCLOMETHICONE 6 (UNII: XHK3U310BA) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 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) ACACIA (UNII: 5C5403N26O) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE DISODIUM (UNII: 7FLD91C86K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-447-01 1 g in 1 PACKET 2 NDC:13537-447-04 1 in 1 BOX 2 NDC:13537-447-03 5 g in 1 BOTTLE, PLASTIC 3 NDC:13537-447-06 1 in 1 BOX 3 NDC:13537-447-05 50 g in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/01/2013 Labeler - Ventura Corporation LTD. (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-447) Establishment Name Address ID/FEI Business Operations Yobel Supply Chain Management S.A. (Peru) 934116930 MANUFACTURE(13537-447)