Label: ULTRA COLOR RICH MEGA IMPACT- octinoxate, oxybenzone lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 10096-0188-1 - Packager: Avon Products, 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 December 22, 2009
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
- WARNINGS
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS / INGRÉDIENTS
INACTIFS: DIISOPROPYL DIMER DILINOLEATE
POLYGLYCERYL-2 DIISOSTEARATE
LANOLIN
PETROLATUM
POLYBUTENE
STEARYL/PPG-3 MYRISTYL ETHER DIMER DILINOLEATE
SUCROSE ACETATE ISOBUTYRATE
MICROCRYSTALLINE WAX/CIRE MICROCRISTALLINE
POLYETHYLENE
OZOKERITE
CERESIN
PHENYL TRIMETHICONE
POLYMETHYLSILSESQUIOXANE
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL
CALCIUM SODIUM BOROSILICATE
BARIUM SULFATE
CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE
SILICA
TOCOPHERYL ACETATE
ALLANTOIN
ETHYLENE/PROPYLENE/STYRENE COPOLYMER
ACRYLATES COPOLYMER
PARFUM/FRAGRANCE
ALLYL METHACRYLATES CROSSPOLYMER
WATER/EAU
LECITHIN
C12-15 ALKYL BENZOATE
HYDROXYETHYL UREA
BUTYLENE/ETHYLENE/STYRENE COPOLYMER
TIN OXIDE
PENTYLENE GLYCOL
HYDROLYZED SILK
TAMARINDUS INDICA SEED EXTRACT
RETINYL PALMITATE
UREA
ASCORBYL PALMITATE
BETA-CAROTENE
MAY CONTAIN:
MICA/CI 77019
IRON OXIDES
TITANIUM DIOXIDE/CI 77891
RED 33 LAKE/CI 17200
RED 7 LAKE
RED 6/CI 15850
RED 6 LAKE/CI 15850
BISMUTH OXYCHLORIDE/CI 77163
BLUE 1 LAKE/CI 42090
CARMINE/CI 75470
YELLOW 5 LAKE/CI 19140
YELLOW 6 LAKE
YELLOW 10 LAKE/CI 47005
RED 7/CI 15850
RED 28 LAKE/CI 45410
RED 36/CI 12085
RED 40 LAKE/CI 16035
ORANGE 5/CI 45370
RED 21/CI 45380
RED 22 LAKE/CI 45380
RED 27 LAKE/CI 45410
RED 30 LAKE/CI 73360
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ULTRA COLOR RICH MEGA IMPACT
octinoxate, oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0188 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 150 mg in 3 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 90 mg in 3 g Inactive Ingredients Ingredient Name Strength LANOLIN (UNII: 7EV65EAW6H) PETROLATUM (UNII: 4T6H12BN9U) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) BARIUM SULFATE (UNII: 25BB7EKE2E) ALLANTOIN (UNII: 344S277G0Z) WATER (UNII: 059QF0KO0R) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) PENTYLENE GLYCOL (UNII: 50C1307PZG) UREA (UNII: 8W8T17847W) ASCORBYL PALMITATE (UNII: QN83US2B0N) BETA CAROTENE (UNII: 01YAE03M7J) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10096-0188-1 3 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/22/2009 Labeler - Avon Products, Inc. (001468693) Establishment Name Address ID/FEI Business Operations Avon Products, Inc. 001807106 manufacture
