Label: LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50- octinoxate, titanium dioxide, homosalate, octisalate, oxybenzone, and zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-901-01, 13537-901-02 - 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 October 13, 2014
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
Water, dicaprylyl carbonate, propylheptyl caprylate, glyceryl stearate, potassium cetyl phosphate, alcohol denat., cyclohexasiloxane, polymethylsilsesquioxane, glycerin, sorbitan stearate, bis-ethylhexyl 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, propylparaben, chlorphenesin, butylene glycol, helianthus annuus (sunflower) seed extract, mica, ppg-1-peg-9 lauryl glycol ether, triethoxycaprylylsilane, cyclopentasiloxane, hedera helix (ivy) leaf/stem extract, phytic acid, sodium polyacrylate.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box
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INGREDIENTS AND APPEARANCE
LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50
octinoxate, titanium dioxide, homosalate, octisalate, oxybenzone, and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-901 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.062 g in 1 mL Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 0.05 g in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.05 g in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.04 g in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.039 g in 1 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) bis-ethylhexyl hydroxydimethoxy benzylmalonate (UNII: 7D4Q5YJ8NV) 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) phenoxyethanol (UNII: HIE492ZZ3T) methylparaben (UNII: A2I8C7HI9T) ambrosia peruviana leaf (UNII: 458F79CGBF) cetostearyl alcohol (UNII: 2DMT128M1S) cetyl palmitate (UNII: 5ZA2S6B08X) xanthan gum (UNII: TTV12P4NEE) caprylyl glycol (UNII: 00YIU5438U) propylparaben (UNII: Z8IX2SC1OH) chlorphenesin (UNII: I670DAL4SZ) butylene glycol (UNII: 3XUS85K0RA) sunflower seed (UNII: R9N3379M4Z) mica (UNII: V8A1AW0880) ppg-1-peg-9 lauryl glycol ether (UNII: 5R8J43K25L) triethoxycaprylylsilane (UNII: LDC331P08E) cyclomethicone 5 (UNII: 0THT5PCI0R) hedera helix leaf (UNII: ZP9XFG71A7) fytic acid (UNII: 7IGF0S7R8I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-901-02 1 in 1 BOX 1 NDC:13537-901-01 30 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 10/14/2014 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-901)
