Label: LBEL PROTEGE EXPERT- ensulizole, octinoxate, octisalate, oxybenzone, and titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-304-01, 14783-304-02, 14783-304-03, 14783-304-04, view more14783-304-05 - Packager: Ventura International Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 February 23, 2011
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
aqua (water), dicaprylyl carbonate, c12-15 alkyl benzoate, vp/eicosene copolymer, triethanolamine, methyl methacrylate crosspolymer, dimethicone, cyclopentasiloxane, cetearyl alcohol, sorbitan stearate, glyceryl stearate, potassium cetyl phosphate, tocopheryl acetate, cyclohexasiloxane, silica, trimethylsiloxysilicate, phenoxyethanol, methicone, ceteareth-20, methylparaben, xanthan gum, mannitol, parfum (fragrance), propylparaben, butylparaben, ethylparaben, isobutylparaben, arginine, cyclodextrin, dextrin, faex extract (yeast extract), histidine hydrochloride (histidine hci), pisum sativum extract (pisum sativum (pea) extract), acetyltyrosine, disodium succinate, khaya senegalensis bark extract, nicotinamide adenine dinucleotide, pyridoxine hci, aspartic acid.
- PRINCIPAL DISPLAY PANEL - 50 ml Carton
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INGREDIENTS AND APPEARANCE
LBEL PROTEGE EXPERT
ensulizole, octinoxate, octisalate, oxybenzone, and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-304 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole .03 g in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate .075 g in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate .05 g in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone .06 g in 1 mL Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide .039 g in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) dicaprylyl carbonate (UNII: 609A3V1SUA) alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ) dimethicone (UNII: 92RU3N3Y1O) cyclomethicone 5 (UNII: 0THT5PCI0R) cetostearyl alcohol (UNII: 2DMT128M1S) sorbitan monostearate (UNII: NVZ4I0H58X) glyceryl monostearate (UNII: 230OU9XXE4) potassium cetyl phosphate (UNII: 03KCY6P7UT) cyclomethicone 6 (UNII: XHK3U310BA) silicon dioxide (UNII: ETJ7Z6XBU4) phenoxyethanol (UNII: HIE492ZZ3T) polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY) methylparaben (UNII: A2I8C7HI9T) xanthan gum (UNII: TTV12P4NEE) mannitol (UNII: 3OWL53L36A) propylparaben (UNII: Z8IX2SC1OH) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) isobutylparaben (UNII: 0QQJ25X58G) arginine (UNII: 94ZLA3W45F) yeast (UNII: 3NY3SM6B8U) histidine monohydrochloride (UNII: 1D5Q932XM6) pea (UNII: W4X7H8GYFM) sodium succinate anhydrous (UNII: V8ZGC8ISR3) khaya senegalensis bark (UNII: 1S7EDA839L) nadide (UNII: 0U46U6E8UK) pyridoxine hydrochloride (UNII: 68Y4CF58BV) aspartic acid (UNII: 30KYC7MIAI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-304-02 1 in 1 BOX 1 NDC:14783-304-01 50 mL in 1 BOTTLE 2 NDC:14783-304-04 1 in 1 BOX 2 NDC:14783-304-03 5 mL in 1 BOTTLE 3 NDC:14783-304-05 1 mL in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 04/19/2011 Labeler - Ventura International Ltd. (603192787) Establishment Name Address ID/FEI Business Operations Bel Star S.A. 880160197 MANUFACTURE