Label: AVON TRUE COLOR FLAWLESS CREAM TO POWDER FOUNDATION- octinoxate, titanium dioxide cream

  • 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 14, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

    Octinoxate 6.3%....................

    Titanium Dioxide 3.16%................

  • PURPOSE

    Purpose

    .....Sunscreen

    .....Sunscreen

  • INDICATIONS & USAGE

    Uses

    • helps prevent sunburn

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure

    • children under 6 months of age: ask a doctor

    • reapply at least every 2 hours

    • use a water resistant sunscreen if swimming or sweating

    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    limit time in the sun, especially from 10 a.m.-2 p.m.
    wear long-sleeved shirts, pants, hats, and sunglasses

  • STORAGE AND HANDLING

    Other information

    • protect the product in this container from excessive heat and direct sun

  • INACTIVE INGREDIENT

    Inactive Ingredients: PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE, DIISOPROPYL DIMER DILINOLEATE, MICROCRYSTALLINE WAX/CIRE MICROCRISTALLINE, CALCIUM SODIUM BOROSILICATE, CETYL RICINOLEATE, HYDROGENATED COCO-GLYCERIDES, SILICA, TRIBEHENIN, POLYMETHYL METHACRYLATE, ETHYLENE/METHACRYLATE COPOLYMER, ETHYLPARABEN, METHYLPARABEN, MAGNESIUM MYRISTATE, HYDRATED SILICA, ALUMINA, DIMETHICONE, ISOPROPYL TITANIUM TRIISOSTEARATE, BORON NITRIDE, CETEARYL DIMETHICONE CROSSPOLYMER, CAPRYLYL METHICONE, PEG/PPG-20/23 DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, KAOLIN. MAY CONTAIN: IRON OXIDES, TITANIUM DIOXIDE/CI 77891, MICA/CI 77019, BLUE 1 LAKE/CI 42090, BISMUTH OXYCHLORIDE/CI 77163

  • QUESTIONS

    Questions or Comments?

    Call toll free 1-800-FOR-AVON

  • PRINCIPAL DISPLAY PANEL

    image of PDPimage of DFBimage of DFB

  • INGREDIENTS AND APPEARANCE
    AVON TRUE COLOR  FLAWLESS CREAM TO POWDER FOUNDATION
    octinoxate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71110-0007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE63.1 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE31.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    MICA (UNII: V8A1AW0880)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PEG/PPG-20/23 DIMETHICONE (UNII: XK68QT7HWY)  
    KAOLIN (UNII: 24H4NWX5CO)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    CETYL RICINOLEATE (UNII: 1P677500YD)  
    PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71110-0007-21 in 1 CARTON12/19/2017
    1NDC:71110-0007-19 g in 1 CASE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/19/2017
    Labeler - Avon Products, Inc. (001468693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avon Products, Inc.544863277manufacture(71110-0007)