Label: LBEL- octinoxate and oxybenzone lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-081-61, 14783-081-62 - 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
Diisopropyl dimer dilinoleate, methyl hydrogenated rosinate, isostearyl neopentanoate, castor isostearate beeswax succinate, ci 77019 (mica), ethylhexyl methoxycinnamate, hydrogenated polycyclopentadiene, polyethylene, copernicia cerifera (carnauba) wax, euphorbia cerifera (candelilla) wax, ozokerite, ethylhexyl palmitate, isododecane, paraffin, hydrogenated polyisobutene, polyglyceryl-3 diisostearate, glyceryl isostearate, isostearyl alcohol, dipalmitoyl hydroxyproline, benzophenone-3, ceramide 3, butyrospermum parkii (shea butter), beta-sitosterol, dimethicone, silica silylate, luffa cylindrica seed oil, silica, propylparaben, methylparaben, disteardimonium hectorite, ppg-26-buteth-26, peg-40 hydrogenated castor oil, polysorbate 80, parfum (fragance), hedera helix (ivy) leaf/stem extract, trimethylsiloxysilicate, bht, tocopheryl acetate, retinyl palmitate, ascorbyl palmitate, bioflavonoids, allantoin. May contain: ci 45380:2 (red 21 lake), ci 77491, ci 77492, ci 77499 (iron oxides), ci 15850:1 (red 7 lake), ci 19140 (yellow 5 lake), ci 77891 (titanium dioxide), ci 77163 (bismuth xychloride), talc.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4 g Carton
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INGREDIENTS AND APPEARANCE
LBEL COULEUR LUXE ROUGE AMPLIFIER XP
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-081 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.18 g in 4 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.0036 g in 4 g Inactive Ingredients Ingredient Name Strength carnauba wax (UNII: R12CBM0EIZ) candelilla wax (UNII: WL0328HX19) ethylhexyl palmitate (UNII: 2865993309) isododecane (UNII: A8289P68Y2) paraffin (UNII: I9O0E3H2ZE) isostearyl alcohol (UNII: Q613OCQ44Y) dipalmitoyl hydroxyproline (UNII: E6AHA53N1H) shea butter (UNII: K49155WL9Y) .beta.-sitosterol (UNII: S347WMO6M4) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) propylparaben (UNII: Z8IX2SC1OH) methylparaben (UNII: A2I8C7HI9T) polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F) polysorbate 80 (UNII: 6OZP39ZG8H) kalmia latifolia leaf (UNII: 79N6542N18) butylated hydroxytoluene (UNII: 1P9D0Z171K) vitamin a palmitate (UNII: 1D1K0N0VVC) ascorbyl palmitate (UNII: QN83US2B0N) allantoin (UNII: 344S277G0Z) D&C red no. 21 (UNII: 08744Z6JNY) Aluminum Oxide (UNII: LMI26O6933) 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) titanium dioxide (UNII: 15FIX9V2JP) talc (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-081-62 1 in 1 BOX 1 NDC:14783-081-61 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)
