Label: TIMELESS AGE DEFYING SPF 20 MERLE NORMAN- octinoxate, oxybenzone cream

  • 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 January 23, 2017

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  • ACTIVE INGREDIENT

    Active Ingredients          purpose

    Octinoxate 7.5%            Sunscreen

    Oxybenzone 2.0%         Sunscreen

  • PURPOSE

    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

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    Warnings

    · For external use only
    · Do not use on damaged or broken skin
    · When using this product keep out of eyes. Rinse with water to remove.

  • DOSAGE & ADMINISTRATION

    Directions

    For sunscreen use:

    · Apply liberally 15 minutes before sun exposure

    · Use a water resistant sunscreen if swimming or sweating

    · Reapply at least every 2 hours

    · 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
    · Children under 6 months: Ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients: Water (Aqua), Titanium Dioxide, Butylene Glycol, Octldodecyl Neopentanoate, Cyclopentasoloxane, Isodecyl Neopentanoate, Iron Oxides, Stearic Acid, Phenyl Trimethicone, Propylene Glycol Stearate SE, Squalane, Triethanolamine, Dipalmitoyl Hydroxyproline, Trilaurin, Ceramide 3, Hyaluronic Acid, Glycine Soja, ( Soybean) Seed Extract, Atelocollagen, Sodium Hyaluronate, Palmitoyl Oligopeptide, Ascorbyl Palmitate, Tocopheryl Acetate, Propylene Glycol Dipelargonate, Ethylene/ Acrylic Acid Copolymer, Panthenol, Allantoin, Lecithin, Glyceryl Polymethacrylate, Dimethionol, Cetyl Phosphate, Tricaprylin, Mica ( Cl 77019), Stearyl Alcohol, PEG-8, Cellulose gum, PEG-12 Dimethicone, Silica, Polyquaternium-24, Sodium Chondroitin Sulfate, Magnesium Aluminum Silicate, Carbomer, Polysorbate 20, Tetrasodium EDTA, Disodium EDTA, Diazolidinyl Urea, BHT, Ethylene Dodecanedioate Phenoxyethanol

  • PRINCIPAL DISPLAY PANEL

    Timeless

    Age-Defying Makeup SPF 20

    Merle Norman

    30 mL 1 FL. OZ.

    carton

    bottle

  • INGREDIENTS AND APPEARANCE
    TIMELESS AGE DEFYING SPF 20  MERLE NORMAN
    octinoxate, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-115
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.25 g  in 30 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE.6 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SQUALANE (UNII: GW89575KF9)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    TRILAURIN (UNII: 7FP2Z3RVUV)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    TRICAPRYLIN (UNII: 6P92858988)  
    MICA (UNII: V8A1AW0880)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57627-115-021 in 1 BOX05/05/2011
    1NDC:57627-115-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/05/2011
    Labeler - Merle Norman (008479388)
    Registrant - Merle Norman (008479388)
    Establishment
    NameAddressID/FEIBusiness Operations
    Merle Norman008479388manufacture(57627-115)
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