Label: SKIN ELEMENTS LIQUID VEIL FOUNDATION BROAD SPECTRUM SPF 25 LIGHT- octinoxate, octocrylene, avobenzone 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 March 21, 2014

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

  • Drug Facts

  • Active Ingredients

    Octinoxate 5.0%
    Octocrylene 4.0%
    Avobenzone 2.7%

  • Purpose

    Sunscreen

  • Use

    • 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 not use

    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 rash or irritation 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.
    • Reapply:
      • after 40 minutes of swimming or sweating
      • immediately after towel drying
      • 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 a 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 of age: Ask a doctor.
  • Inactive Ingredients

    Water, Talc, Dimethicone, Propanediol, Polyester-8, PEG-8 Beeswax, Glycereth-6 Tricocoate, Cetyl Alcohol, Magnesium Stearate, C10-18 Triglycerides, Phenoxyethanol, Caprylyl Glycol, Potassium Sorbate, Sodium PEG-4 PEI-6 Phosphonate, Ceteth-20, Aluminum Hydroxide, Microcrystalline Cellulose, Olea Europea (Olive) Fruit Extract, Triticum Culgare (Wheat) Germ Extract, Helianthus Annuus (Sunflower) Seed Oil, Coleus Forskohilii Root Extract, Polygonum Cuspidatum (Japanese Bamboo) Extract, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Mica, Steareth-20, Polyacrylamide, Stearic Acid, Tocopheryl Acetate, Sodium Chloride, Cellulose Gum, C13-13 Isoparaffin, Sodium Hydroxide, Laureth-7, Rhodochrosite Extract, Hematite Extract, Sea Water, Malachite Extract, Lycium Barbarum Fruit Extract, Smithsonite Extract, Sodium Benzoate, Olivine Extract. May Contain: Titanium Dioxide, Iron Oxides.

  • Other Information

    • Protect the product this product from excessive heat and direct sun.
  • Questions or comments?

    Call Laura Geller Beauty, LLC
    1 (800) MAKE UP4

  • Carton Package Label

    LAURA GELLER
    BEAUTY INGENUITY

    skin elements
    liquid veil foundation

    broad spectrum
    SPF 25

    LIGHT

    1.7 fl. oz./50 ml

    Treat skin to the best of both worlds with this make-up/skincare hybrid formula! The lightweight liquid hydrates kin while providing natural, sheer-to-medium coverage and SPF 25 UVA/UVB protection. Skin is nourished with ​Mineral Water ​and ​Goji Berry ​and protected with a powerful antioxidant complex. ​Vitamin E​ conditions and helps protect skin. with a veil-like texture to blur fine lines and wrinkles, Skin Elements leaves skin radiant, even and healthy looking... the elements of sun-protected beauty!

    TO USE: Apply over your favorite Spackle​®
    Under Make-Up Primer with a foundation brush or fingertips. Smooth until perfectly blended. Avoid the eye area.

    Of the women who have tried Skin Elements Liquid Veil SPF25 Foundation:

    • 96% of women saw an immediate improvement in skin moisturization.
    • 93% of women saw an immediate improvement in skin redness.
    • 96% of women saw an immediate improve in skin soothing.
    • In a biophysical assessment of the skin, Skin Elements increased hydration by 64% after one month of use
    • In a biophysical assessment of the skin, Skin Elements decreased skin redness by 28% after one month of use. 

    Made in Italy

    DISTRIBUTED BY
    LAURA GELLER BEAUTY, LLC
    NEW YORK, NY 10022

    www.laurageller.com

    00-74202-02-RE

    UPC/FPO

    849154003921

    Carton Label

  • Bottle Label

    ​See carton for complete
    Drug Facts information

    Naritaweg 165, 1043 B W Amsterdam

    The Netherlands

    bottle label

    shade label

  • INGREDIENTS AND APPEARANCE
    SKIN ELEMENTS LIQUID VEIL FOUNDATION BROAD SPECTRUM SPF 25  LIGHT
    octinoxate, octocrylene, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51389-251
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE40 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE27 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TALC (UNII: 7SEV7J4R1U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GLYCERETH-6 (UNII: X6PP1WBY6T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CETETH-20 (UNII: I835H2IHHX)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    BLACK OLIVE (UNII: 2M6QWV94OC)  
    WHEAT GERM (UNII: YR3G369F5A)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PLECTRANTHUS BARBATUS ROOT (UNII: V5741391RG)  
    POLYGONUM CUSPIDATUM LEAF (UNII: 2540B7G25G)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MICA (UNII: V8A1AW0880)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    LAURETH-7 (UNII: Z95S6G8201)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51389-251-001 in 1 CARTON
    150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/21/2014
    Labeler - Laura Geller Beauty, LLC (199474524)