Label: LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50- homosalate, octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 43596-0001-0, 43596-0001-1, 43596-0001-2 - 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 March 25, 2012
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- L'BEL DEFENSE 365 Oil-Free Daily Protective Facial Lotion SPF 50
- Active Ingredients
- Uses
- Warnings
- Directions
- Other Information
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Inactive ingredients
Aqua (Water), dicaprylyl carbonate, propylheptyl caprylate, glyceryl stearate, potassium cetyl phosphate, alcohol denat., cyclohexasiloxane, polymethylsilsesquioxane, glycerin, sorbitan stearate, bis0ethylhexyl hydroxydimethoxy benzylmalonate, dimethicone, tocopheryl acetate, silica, methicone, peg-8, ceteareth-12, ceteareth-20, propylene glycol, phenoxyethanol, methylparaben, ambrosia peruviana leaf extract, cetearyl alcohol, cetyl palmitate, xanthan gum, caprylyl glycol, mica, propylparaben, butylene glycol, helianthus annuus seed extract (helianthus annuus (sunflower) seed extract), ppg-1-peg-9-lauryl glycol ether, chlorophenesin, triethoxycaprylylsilane, cyclopentasiloxane, hedera helix leaf/stem extract (hedera helix (ivy) leaf/stem extract), phytic acid, sodium polyacrylate.
- Purpose
- PRINCIPAL DISPLAY PANEL
- L'BEL DEFENSE 365 Oil-Free Daily Protective Facial Lotion SPF 50
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INGREDIENTS AND APPEARANCE
LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50
homosalate, octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 mL in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mL in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.24 mL in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3.92 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) ALCOHOL (UNII: 3K9958V90M) CYCLOMETHICONE 6 (UNII: XHK3U310BA) GLYCERIN (UNII: PDC6A3C0OX) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CETEARETH-12 (UNII: 7V4MR24V5P) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) AMBROSIA PERUVIANA LEAF (UNII: 458F79CGBF) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL PALMITATE (UNII: 5ZA2S6B08X) XANTHAN GUM (UNII: TTV12P4NEE) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MICA (UNII: V8A1AW0880) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) CHLORPHENESIN (UNII: I670DAL4SZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) HEDERA HELIX LEAF (UNII: ZP9XFG71A7) FYTIC ACID (UNII: 7IGF0S7R8I) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0001-0 1 mL in 1 POUCH 2 NDC:43596-0001-1 3 mL in 1 TUBE 3 NDC:43596-0001-2 30 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/25/2012 Labeler - Ventura Corporation, LTD (602751344) Establishment Name Address ID/FEI Business Operations MF Productions 266769145 manufacture