Label: LBEL LEDERM 55PLUS JOUR SPF 15 FACIAL TREATMENT AGAINST ADVANCED SIGNS OF AGING DAY - ALL SKIN TYPES- avobenzone, octisalate, octocrylene, and oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-019-01, 14783-019-03, 14783-019-04, 14783-019-05, view more14783-019-06 - Packager: Ventura International 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 1, 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), 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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 g Bottle Carton
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INGREDIENTS AND APPEARANCE
LBEL LEDERM 55PLUS JOUR SPF 15 FACIAL TREATMENT AGAINST ADVANCED SIGNS OF AGING DAY - ALL SKIN TYPES
avobenzone, octisalate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-019 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) 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-019-01 1 g in 1 PACKET 2 NDC:14783-019-04 1 in 1 BOX 2 NDC:14783-019-03 5 g in 1 BOTTLE, PLASTIC 3 NDC:14783-019-06 1 in 1 BOX 3 NDC:14783-019-05 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 International LTD. (603192787) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(14783-019) Establishment Name Address ID/FEI Business Operations Yobel Supply Chain Management S.A. (Peru) 934116930 MANUFACTURE(14783-019)