Label: LBEL- octinoxate, oxybenzone, and titanium dioxide lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-083-61, 14783-083-62 - 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 August 10, 2010
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
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Inactive Ingredients
Ricinus communis seed oil (ricinus communis (castor) seed oil), diisostearyl malate, caprylic/capric truglyceride, decyl oleate, ci 77019 (mica), ozokerite, cera alba (beeswax), copernicia cerifera ( copernicia cerifera (carnauba)wax), candelilla cera (euphorbia cerifera (candelilla) wax), isopropyl lanolate, sorbitan sesquioleate, hydrogenated polyisobutene, vp/hexadecene copolymer, isostearyl neopentanoate, octyldodecano, parfum (fragance), propylparaben, lecithin, bht, dimethicone, arachidyl propionate, tocopheryl acetate, retinyl palmitate, trimethylsiloxysilicate, ethyl linoleate, ethyl linolenate. May contain: ci 77891 (titanium dioxide), ci 77491, ci 77492, ci 77499 (iron oxides), ci 77163 (bismuth oxychloride), ci 15850 (red 6 lake), ci 19140 (yellow 5 lake), ci 15850 (red 7 lake), ci 45410 (red 27 lake), ci 45380 (red 21 lake), talc, ci 42090 (blue 1 lake), oleyl alcohol, c9-13 fluoroalcohol, phosphoric acid, ci 75470 (carmine).
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4 g Carton
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INGREDIENTS AND APPEARANCE
LBEL COULEUR LUXE SUPREME XP
octinoxate, oxybenzone, and titanium dioxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-083 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.0392 g in 4 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.0188 g in 4 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0376 g in 4 g Inactive Ingredients Ingredient Name Strength castor oil (UNII: D5340Y2I9G) medium-chain triglycerides (UNII: C9H2L21V7U) decyl oleate (UNII: ZGR06DO97T) yellow wax (UNII: 2ZA36H0S2V) carnauba wax (UNII: R12CBM0EIZ) candelilla wax (UNII: WL0328HX19) sorbitan sesquioleate (UNII: 0W8RRI5W5A) propylparaben (UNII: Z8IX2SC1OH) butylated hydroxytoluene (UNII: 1P9D0Z171K) dimethicone (UNII: 92RU3N3Y1O) arachidyl propionate (UNII: QV5DAH3MSB) vitamin a palmitate (UNII: 1D1K0N0VVC) ethyl linoleate (UNII: MJ2YTT4J8M) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) D&C red no. 6 (UNII: 481744AI4O) FD&C yellow no. 5 (UNII: I753WB2F1M) D&C red no. 28 (UNII: 767IP0Y5NH) talc (UNII: 7SEV7J4R1U) FD&C blue no. 1 (UNII: H3R47K3TBD) oleyl alcohol (UNII: 172F2WN8DV) phosphoric acid (UNII: E4GA8884NN) mica (UNII: V8A1AW0880) aluminum oxide (UNII: LMI26O6933) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-083-62 1 in 1 BOX 1 NDC:14783-083-61 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/15/2010 Labeler - Ventura International LTD (603192787)
