Label: LBEL- octinoxate and oxybenzone lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-990-04, 14783-990-05, 14783-990-11, 14783-990-12 - Packager: Ventura International, Limited
- 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 November 10, 2010
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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Inactive ingredients
ethylhexyl palmitate, dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, polyethylene, polymethyl methacrylate, (butyrospermum parkii (shea butter), ozokerite, copernicia cerifera (carnauba) wax, tridecyl stearate, neopentyl glycol dicaprylate/dicaprate, octyldodecanol, disteardimonium hectorite, caprylic/capric triglyceride, phenoxyethanol, tocopheryl acetate, aloe barbadensis leaf extract, fragrance, microcrystalline wax, propylene carbonate, silica, methylparaben, petrolatum, phospholipids, bht, cholesterol, butylparaben, ethylparaben, crambe maritima extract, bha, euphorbia cerifera (candelilla) wax, beeswax, polyglyceryl-2 dipolyhydroxystearate, cetearyl glucoside, cetearyl alcohol, propylparaben, isobutylparaben, glycosphingolipids. May contain: mica, titanium dioxide, red 7 lake, iron oxides, yellow 5 lake, red 30 lake, red 21 lake, bismuth oxychloride, talc, red 40 lake, blue 1 lake, carmine, hydrogenated polyisobutene, palmitic acid.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4 g Carton
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INGREDIENTS AND APPEARANCE
LBEL COULEUR LUXE ROUGE IRRESISTIBLE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-990 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.071 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.016 g in 1 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYL PALMITATE (UNII: 2865993309) SHEA BUTTER (UNII: K49155WL9Y) CERESIN (UNII: Q1LS2UJO3A) CARNAUBA WAX (UNII: R12CBM0EIZ) TRIDECYL STEARATE (UNII: A8OE252M6L) OCTYLDODECANOL (UNII: 461N1O614Y) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALOE VERA LEAF (UNII: ZY81Z83H0X) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHOLESTEROL (UNII: 97C5T2UQ7J) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PROPYLPARABEN (UNII: Z8IX2SC1OH) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 7 (UNII: ECW0LZ41X8) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 30 (UNII: 2S42T2808B) D&C RED NO. 21 (UNII: 08744Z6JNY) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) TALC (UNII: 7SEV7J4R1U) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C BLUE NO. 4 (UNII: 0KSY80VYS3) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) PALMITIC ACID (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-990-05 12 in 1 CARTON 1 NDC:14783-990-04 4 g in 1 TUBE 2 NDC:14783-990-12 12 in 1 CARTON 2 NDC:14783-990-11 11.4 g in 1 TRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 11/26/2010 Labeler - Ventura International, Limited (603192787) Establishment Name Address ID/FEI Business Operations BelStar, S.A. 880160197 MANUFACTURE
