Label: REVLON AGE DEFYING WITH DNA ADVANTAGE SPF 20- octinoxate, titanium dioxide make-up liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 14, 2016

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  • Active Ingredients:

    Octinoxate: 3.5%

    Titanium Dioxide 9.5%

    Purpose:

    Sunscreen

  • Uses

    Helps prevent sunburn
    If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • Warnings

    For external use only
    Do notuse on damaged or broken skin
    When using this product: Keep out of eyes. Rinse with water to remove.
    Stop use and ask a doctor if a rash occurs
    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control center right away

  • Directions

    Apply liberally 15 minutes before sun exposure
    Use a water resistant sunscreen if swimming or sweating
    Reapply at least every 2 hours
    Children under 6 months: Ask a doctor.

    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 am - 2 pm
    Wear long-sleeved shirts, pants, hats and sunglasses.

  • Inactive Ingredients

    AQUA ((WATER) EAU),DIMETHICONE,BUTYLENE GLYCOL,GLYCERIN,NEOPENTYL GLYCOL DIHEPTANOATE,ISOSTEARIC ACID,PHENYL TRIMETHICONE,ISOCETYL STEARATE,PENTAERYTHRITYL TETRAISOSTEARATE,ISOTRIDECYL ISONONANOATE,NYLON-12,TRIETHANOLAMINE,POLYACRYLAMIDE,GLYCERYL STEARATE,CAPRYLYL GLYCOL,1,2-HEXANEDIOL,ALUMINA,STEARETH-2,PHOSPHOLIPIDS,C13-14 ISOPARAFFIN,STEARETH-21,METHICONE,LAURETH-7,XANTHAN GUM,MALPIGHIA GLABRA (ACEROLA) FRUIT EXTRACT,NIACINAMIDE,SIMETHICONE,SACCHAROMYCES/PODOPHYLLUM PELTATUM FERMENT FILTRATE,GOSSYPIUM HERBACEUM (COTTON) EXTRACT,VIOLA TRICOLOR EXTRACT,TOCOPHERYL ACETATE,SODIUM LAUROYL LACTYLATE,SODIUM HYALURONATE,HYDROLYZED GLYCOSAMINOGLYCANS,CERAMIDE 3,CERAMIDE 6 II,PHYTOSPHINGOSINE,CARBOMER,ACETYL HEXAPEPTIDE-8,CHOLESTEROL,CERAMIDE 1

  • PRINCIPAL DISPLAY PANEL

    Revlon Age Defying DNA Advantage Foundation

  • INGREDIENTS AND APPEARANCE
    REVLON AGE DEFYING WITH DNA ADVANTAGE SPF 20 
    octinoxate, titanium dioxide make-up liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-616
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    LAURETH-7 (UNII: Z95S6G8201)  
    NYLON-12 (UNII: 446U8J075B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    STEARETH-2 (UNII: V56DFE46J5)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    STEARETH-21 (UNII: 53J3F32P58)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MALPIGHIA GLABRA FRUIT (UNII: B94O42LA9M)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    LEVANT COTTON SEED (UNII: 550E4N439V)  
    VIOLA TRICOLOR (UNII: 9Q24RAI43V)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10967-616-0130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/01/2010
    Labeler - Revlon Consumer Products Corp (788820165)
    Establishment
    NameAddressID/FEIBusiness Operations
    REVLON, INC.809725570manufacture(10967-616)