Label: TINTED LIP CONDITIONER SPF 15 PLUS LAVENDER- octinoxate, octisalate gel
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Contains inactivated NDC Code(s)
NDC Code(s): 40046-0041-1, 40046-0041-2 - Packager: MAKEUP ART COSMETICS
- 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 December 2, 2010
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: PETROLATUM [] RICINUS COMMUNIS (CASTOR) SEED OIL [] POLYBUTENE [] MICROCRYSTALLINE WAX\CERA MICROCRISTALLINA\CIRE MICROCRISTALLINE [] ETHYLENE/PROPYLENE/STYRENE COPOLYMER [] HYDROGENATED POLYISOBUTENE [] SILICA [] TOCOPHERYL ACETATE [] SQUALANE [] LECITHIN [] PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] PERSEA GRATISSIMA (AVOCADO) OIL UNSAPONIFIABLES [] LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER WAX [] ASTROCARYUM MURUMURU SEED BUTTER [] POLYDECENE [] CHOLESTEROL [] TRITICUM VULGARE (WHEAT) GERM OIL [] POLYETHYLENE [] BUTYLENE/ETHYLENE/STYRENE COPOLYMER [] TRIETHOXYCAPRYLYLSILANE [] CALCIUM ALUMINUM BOROSILICATE [] TIN OXIDE [] FLAVOR (AROMA) [] SACCHARIN [] LINALOOL [] GERANIOL [] BHT [] TETRAHEXYLDECYL ASCORBATE [] [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] BLUE 1 LAKE (CI 42090) [] RED 6 (CI 15850) [] RED 7 LAKE (CI 15850) [] RED 28 LAKE (CI 45410) [] RED 30 LAKE (CI 73360) [] RED 33 LAKE (CI 17200) [] YELLOW 5 LAKE (CI 19140) [] YELLOW 6 LAKE (CI 15985)
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INGREDIENTS AND APPEARANCE
TINTED LIP CONDITIONER SPF 15 PLUS LAVENDER
octinoxate, octisalate gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0041 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 mL in 100 mL Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) CASTOR OIL (UNII: D5340Y2I9G) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYISOBUTYLENE (35000 MW) (UNII: 98553S1MHQ) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ALMOND OIL (UNII: 66YXD4DKO9) SHEA BUTTER (UNII: K49155WL9Y) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) CHOLESTEROL (UNII: 97C5T2UQ7J) WHEAT GERM OIL (UNII: 14C97E680P) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) OCTYLTRIETHOXYSILANE (UNII: LDC331P08E) STANNIC OXIDE (UNII: KM7N50LOS6) SACCHARIN (UNII: FST467XS7D) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) D&C RED NO. 6 (UNII: 481744AI4O) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 28 (UNII: 767IP0Y5NH) D&C RED NO. 30 (UNII: 2S42T2808B) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0041-1 1 in 1 CARTON 1 NDC:40046-0041-2 15 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/01/2010 Labeler - MAKEUP ART COSMETICS (010597206) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 205952385 manufacture Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 manufacture Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture Establishment Name Address ID/FEI Business Operations Aramis Inc. 042918826 manufacture Establishment Name Address ID/FEI Business Operations Northtec Bristol 949264774 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Keystone 618107429 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd. 255175580 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd 253616536 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel Establishment Name Address ID/FEI Business Operations Estee Lauder Kabushiki Kaisha 712808195 relabel, repack Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 manufacture