Label: LIP CONDITIONER SPF 15- octinoxate lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 11559-725-01 - Packager: ESTEE LAUDER INC
- 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 March 2, 2012
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- WARNING
- ACTIVE INGREDIENT
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INGREDIENTS
RICINUS COMMUNIS (CASTOR) SEED OIL • CAPRYLIC/CAPRIC TRIGLYCERIDE • EUPHORBIA CERIFERA (CANDELILLA) WAX • BIS-DIGLYCERYL POLYACYLADIPATE-2 • CETYL ACETATE • BEESWAX (CERA ALBA) • MICA • POLYETHYLENE • OLEYL OLEATE • COPERNICIA CERIFERA (CARNAUBA) WAX • BUTYROSPERMUM PARKII (SHEA BUTTER) • POLYDECENE • LANOLIN OIL • BARIUM SULFATE • POLYGLYCERYL-3 DIISOSTEARATE • TOCOPHERYL ACETATE • ASCORBYL PALMITATE • LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER • ACETYLATED LANOLIN ALCOHOL • ALUMINA • BHT <ILN25993>
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 3.8 g Lipstick Carton
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INGREDIENTS AND APPEARANCE
LIP CONDITIONER SPF 15
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-725 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.5 g in 100 g Inactive Ingredients Ingredient Name Strength CASTOR OIL (UNII: D5340Y2I9G) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CANDELILLA WAX (UNII: WL0328HX19) CETYL ACETATE (UNII: 4Q43814HXS) YELLOW WAX (UNII: 2ZA36H0S2V) MICA (UNII: V8A1AW0880) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) OLEYL OLEATE (UNII: 3X3L452Y85) CARNAUBA WAX (UNII: R12CBM0EIZ) SHEA BUTTER (UNII: K49155WL9Y) LANOLIN OIL (UNII: OVV5IIJ58F) BARIUM SULFATE (UNII: 25BB7EKE2E) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBYL PALMITATE (UNII: QN83US2B0N) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-725-01 1 in 1 CARTON 1 3.8 g in 1 CYLINDER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/1998 Labeler - ESTEE LAUDER INC (005914387) Establishment Name Address ID/FEI Business Operations ELGC Kabushiki Kaisha 712808195 RELABEL(11559-725) , REPACK(11559-725) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(11559-725) , RELABEL(11559-725) , REPACK(11559-725) Establishment Name Address ID/FEI Business Operations ARAMIS, INC 042918826 MANUFACTURE(11559-725) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(11559-725) , RELABEL(11559-725) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(11559-725) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(11559-725) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(11559-725) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(11559-725) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(11559-725) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 787336577 MANUFACTURE(11559-725) , RELABEL(11559-725) , REPACK(11559-725) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 949264774 MANUFACTURE(11559-725) , RELABEL(11559-725) , REPACK(11559-725) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 618107429 MANUFACTURE(11559-725) , RELABEL(11559-725) , REPACK(11559-725) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(11559-725) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(11559-725)
