Label: ALMAY WAKE-UP LIQUID MAKE-UP- titanium dioxide, oxctinoxate 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 December 19, 2016

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  • Active Ingredients:

    Titanium Dioxide: 9.0%

    Octinoxate 3.5%

  • 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, Neopentyl Glycol Diheptanoate, Butylene Glycol, Glycerin, Isostearic Acid, Phenyl Trimethicone, Isocetyl Stearate, Isotridecyl Isononanoate, Tromethamine, Pentaerythrityl Tetraisostearate, Tocopheryl Acetate, Sodium Ascorbyl Phosphate, Viola Tricolor Extract, Lecithin, Cucumis Sativus (Cucumber) Fruit Extract, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf (Green Tea) Extract, Cocos Nucifera (Coconut) Water, Caffeine, Nylon-12, Steareth-2, Glyceryl Stearate, Alumina, Propylene Glycol Laurate, Propylene Glycol Stearate, Simethicone, Sorbitan Laurate, Polysorbate 20, Laureth-7, Xanthan Gum, Methicone, C13-14 Isoparaffin, Steareth-21, Stearic Acid, Polyacrylamide, Potassium Sorbate, Caprylyl Glycol, 1,2-Hexanediol

  • Principal Display Panel

    Almay

    Almay Wake-Up Liquid Make-Up

    1 oz/ 30mL

    Label

  • INGREDIENTS AND APPEARANCE
    ALMAY WAKE-UP LIQUID MAKE-UP 
    titanium dioxide, oxctinoxate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0311-0704
    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 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
    NYLON-12 (UNII: 446U8J075B)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
    ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT (UNII: 3RT3536DHY)  
    CAFFEINE (UNII: 3G6A5W338E)  
    STEARETH-2 (UNII: V56DFE46J5)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PROPYLENE GLYCOL LAURATES (UNII: 40KT317HGP)  
    PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)  
    PEG-10 SORBITAN LAURATE (UNII: 4Z93U4C2WN)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LAURETH-7 (UNII: Z95S6G8201)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0311-0704-0130 mL in 1 TUBE; Type 0: Not a Combination Product04/23/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/23/2013
    Labeler - Almay, Inc. (064988652)
    Establishment
    NameAddressID/FEIBusiness Operations
    REVLON, INC.809725570manufacture(0311-0704)
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