Label: RICH LIP COLOR SPF 12- octinoxate, octisalate lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 64141-009-01, 64141-009-02 - Packager: Bobbi Brown Professional Cosmetics 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 June 6, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: OCTYLDODECANOL [] TRIISOSTEARIN [] DIISOSTEARYL MALATE [] DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE [] MICROCRYSTALLINE WAX [] POLYETHYLENE [] POLYBUTENE [] PARAFFIN [] VP/HEXADECENE COPOLYMER [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER [] OZOKERITE [] DICALCIUM PHOSPHATE [] IRVINGIA GABONENSIS KERNEL BUTTER [] OCTYLDODECYL PCA [] HYDROGENATED COCO-GLYCERIDES [] DIPALMITOYL HYDROXYPROLINE [] STEARALKONIUM BENTONITE [] ETHYL VANILLIN [] PROPYLENE CARBONATE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] TOCOPHEROL [] SILICA [] [+/- MICA [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] RED 7 LAKE (CI 15850) [] BLUE 1 LAKE (CI 42090) [] YELLOW 5 LAKE (CI 19140) [] YELLOW 10 (CI 47005) [] RED 22 LAKE (CI 45380) [] RED 30 LAKE (CI 73360) [] CARMINE (CI 75470) [] TITANIUM DIOXIDE (CI 77891) [] RED 30 (CI 73360) [] RED 6 (CI 15850) [] YELLOW 6 LAKE (CI 15985) [] RED 33 LAKE (CI 17200) [] RED 21 (CI 45380) [] ORANGE 5 (CI 45370) [] RED 28 LAKE (CI 45410) [] YELLOW 5 (CI 19140) [] YELLOW 10 LAKE (CI 47005) [] BRONZE POWDER (CI 77400) [] RED 22 (CI 45380)
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RICH LIP COLOR SPF 12
octinoxate, octisalate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64141-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5.0 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength OCTYLDODECANOL (UNII: 461N1O614Y) DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) PARAFFIN (UNII: I9O0E3H2ZE) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) IRVINGIA GABONENSIS SEED (UNII: 0J4W1PR213) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) VANILLIN (UNII: CHI530446X) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) TOCOPHEROL (UNII: R0ZB2556P8) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) COCHINEAL (UNII: TZ8Z31B35M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64141-009-01 1 in 1 CARTON 1 NDC:64141-009-02 3.8 g in 1 CARTRIDGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2010 Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279) 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 Establishment Name Address ID/FEI Business Operations Intercos 338578473 manufacture
