Label: ALMAY AGE SMART SHADE CC LUMINOUS PRIMER SPF 15- zinc oxide, 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 October 22, 2019

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  • Active Ingredients:

    Zinc Oxide: 3.3%

    Titanium Dioxide 4.3%

  • 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), Cyclopentasiloxane, Dimethicone, Phenyl Trimethicone, PEG-9 Polydimethylsiloxyethyl Dimethicone, Glycerin, Boron Nitride, Adipic Acid/Neopentyl Glycol Crosspolymer, Trimethylsiloxysilicate, Butylene Glycol, Disteardimonium Hectorite, Dimethicone/PEG-10/15 Crosspolymer, Alumina, Dimethicone Crosspolymer, Methyl Acetylglycyrrhetinoyl Hydroxyprolinate, Thermus Thermophillus Ferment, Alpha-Glucan Oligosaccharide, Polymnia Sonchifolia Root Juice, Tocopherol, Niacinamide, Methylsilanol Hydroxyproline Aspartate, Lactobacillus, Hydrolyzed Triticum Monococcum Seed Extract, Maltodextrin, Sodium Chloride, Polyglyceryl-3 Diisostearate, Methicone, Xanthan Gum, Triethoxycaprylylsilane, Isopropyl Titanium Triisostearate, Polymethyl Methacrylate, Sodium Citrate, Dipropylene Glycol, Sodium Benzoate, Tetrasodium EDTA, Phenoxyethanol, Methylparaben, Ethylparaben, Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, 77492, 77499)

  • Principal Display Panel

    Almay 

    Smart Shade CC Luminous Primer

    Broad Spectrum

    SPF 15

    1.0 fL. OZ/30 mL

    image description

  • INGREDIENTS AND APPEARANCE
    ALMAY AGE SMART SHADE CC LUMINOUS PRIMER SPF 15 
    zinc oxide, titanium dioxide make-up liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0311-0706
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.3 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
    .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
    LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0311-0706-0130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product11/14/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/14/2013
    Labeler - Almay, Inc. (064988652)
    Establishment
    NameAddressID/FEIBusiness Operations
    REVLON, INC.809725570manufacture(0311-0706)
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