Label: LBEL LEDERM 45 PLUS JOUR FACIAL AGAINST NOTICEABLE SIGNS OF AGING- avobenzone, octisalate, octocrylene, and oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-994-01, 13537-994-02 - 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 November 16, 2019
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
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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.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
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INGREDIENTS AND APPEARANCE
LBEL LEDERM 45 PLUS JOUR FACIAL AGAINST NOTICEABLE SIGNS OF AGING
avobenzone, octisalate, octocrylene, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-994 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 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.05 g in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.03 g in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.05 g in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-994-02 1 in 1 BOX 10/24/2016 1 NDC:13537-994-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 10/24/2016 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-994)