Label: LBEL- octinoxate and oxybenzone lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-220-61, 13537-220-62 - 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 (castor) seed oil, caprylic/capric triglyceride, ethylhexyl palmitate, euphorbia cerifera (candelilla) wax, glyceryl isostearate, polyethylene, methyl hydrogenated rosinate, lanolin oil, copernicia cerifera (carnauba) wax, isostearyl alcohol, polybutene, butyrospermum parkii (shea butter), ci 77019 (mica), beta-sitosterol, silica silylate, phenoxyethanol, menthol, octyldodecanol, dimethicone, tribehenin, luffa cylindrica seed oil, propylparaben, methylparaben, cera microcristallina (microcrystalline wax), sorbitan isostearate, parfum (fragance), silica dimethyl silylate, petrolatum, phospholipids, butylparaben, ethylparaben, butylene glycol, cholesterol, isobutylparaben, trimethylsiloxysilicate, cera alba (beewax), cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, sodium hyaluronate, glycosphingolipids, palmitoyl oligopeptide. May contain: ci 77891 (titanium dioxide), ci 15850:1 (red 7 lake), ci 75470 (carmine), ci 77491, ci 77492, ci 77499 (iron oxides), ci 19140 (yellow 5 lake), ci 45380:2 (red 21 lake), ci 45410:1 (red 27 lake), ci 42090 (blue 1 lake), silica, bht, hydrogenated polyisobutene, palmitic acid, talc.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4 g Carton
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INGREDIENTS AND APPEARANCE
LBEL EFFET PARFAIT ROUGE VOLUMESSE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-220 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.2688 g in 4 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.0896 g in 4 g Inactive Ingredients Ingredient Name Strength castor oil (UNII: D5340Y2I9G) medium-chain triglycerides (UNII: C9H2L21V7U) ethylhexyl palmitate (UNII: 2865993309) candelilla wax (UNII: WL0328HX19) lanolin (UNII: 7EV65EAW6H) carnauba wax (UNII: R12CBM0EIZ) isostearyl alcohol (UNII: Q613OCQ44Y) shea butter (UNII: K49155WL9Y) mica (UNII: V8A1AW0880) .beta.-sitosterol (UNII: S347WMO6M4) silicon dioxide (UNII: ETJ7Z6XBU4) phenoxyethanol (UNII: HIE492ZZ3T) menthol (UNII: L7T10EIP3A) octyldodecanol (UNII: 461N1O614Y) dimethicone (UNII: 92RU3N3Y1O) tribehenin (UNII: 8OC9U7TQZ0) luffa (UNII: F0R3Y60C6V) propylparaben (UNII: Z8IX2SC1OH) methylparaben (UNII: A2I8C7HI9T) sorbitan (UNII: 6O92ICV9RU) petrolatum (UNII: 4T6H12BN9U) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) butylene glycol (UNII: 3XUS85K0RA) cholesterol (UNII: 97C5T2UQ7J) isobutylparaben (UNII: 0QQJ25X58G) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) hyaluronate sodium (UNII: YSE9PPT4TH) titanium dioxide (UNII: 15FIX9V2JP) D&C RED NO. 7 (UNII: ECW0LZ41X8) aluminum oxide (UNII: LMI26O6933) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) butylated hydroxytoluene (UNII: 1P9D0Z171K) palmitic acid (UNII: 2V16EO95H1) talc (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-220-62 1 in 1 BOX 1 NDC:13537-220-61 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., (602751344)
