Label: AWAKEN BY QUALITY CHOICE ILLUMINATING DAILY MOISTURIZER BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, octisalate and octocrylene cream

  • Category: HUMAN OTC DRUG LABEL

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 1, 2014

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  • Active ingredient

    Avobenzone 3.0%

    Octisalate 5.0%

    Octocrylene 8.0%

  • 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 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 occurs.
  • Keep Out of Reach of Children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply liberally 15 minutes before sun exposure.
    Reapply at least every 2 hours.
    Use water resistant sunscreen if swimming or sweating.
    Children under 6 months of age: 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 a.m. – 2 p.m.
    Wear long-sleeved shirts, pants, hats and sunglasses.
  • Other Information

    Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    water, C12-15 alkyl benzoate, arachidyl alcohol, beheynl alcohol, arachidyl glucoside, cetearyl alcohol, cetearyl glucoside, steareth-2, glycerin, steareth-21, dimethicone, phenyl trimethicone, polyacrylamide, C13-14 isoparaffin, laureth-7, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, panthenol (pro-vitamin B5), polymethyl methacrylate, lecithin, soy isoflavones, polysorbate 80, alcohol, benzyl alcohol, disodium EDTA, fragrance, benzalkonium chloride, BHT, triethanolamine.

  • Package/Label Principal Display Panel

    Awaken
    by Quality Choice®

    illuminating
    daily moisturizer

    BROAD SPECTRUM
    SPF 15 SUNSCREEN

    Clinically proven

    Evens out skin tone & texture

    Exclusive soy complex
    & light diffusers

    *Compare to Aveeno® Positively Radiant

    4 FL OZ. (120 mL)

    THE RESULTS

    Illuminating Daily Moisturizer Broad Spectrum SPF 15 Sunscreen is clinically proven to:

    Leave smoother skin
    Improve skin’s tone and texture
    Visibly even out discolorations
    Improve skin’s radiance

    This unique moisturizer has an exclusive soy complex and light diffusers that work together to naturally even out skin tone and texture, immediately reflecting light to visibly smooth skin imperfections, bringing out skin’s natural radiance. This light and quickly absorbed moisturizer is gentle enough for sensitive skin to help maintain healthy-looking skin.

    DIRECTIONS FOR USE

    After cleansing, smooth over face and neck every day for healthier, younger-looking skin.

    Soy is nature’s secret for naturally radiant skin. Soy in known for multiple health & skin benefits including: moisturizing, texture smoothing, and evening out skin tone for healthier looking skin.

    This oil-free hypoallergenic and non-comedogenic product is gentle enough for everyday use.

    Dermatologists recommend the everyday use of an SPF 15 sunscreen as essential to healthy skin care.

    *This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Aveeno® Positively Radiant™

    SATISFACTION GUARANTEED

    Distributed by C.D.M.A., Inc.©
    43157 W. Nine Mile
    Novi, MI 48376-0995
    www.qualitychoice.com
    Questions: 248-449-9300

    Made in Israel
    52326 CD C1

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    AWAKEN BY QUALITY CHOICE ILLUMINATING DAILY MOISTURIZER BROAD SPECTRUM SPF 15 SUNSCREEN 
    avobenzone, octisalate and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-254
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    STEARETH-2 (UNII: V56DFE46J5)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARETH-21 (UNII: 53J3F32P58)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    SOY ISOFLAVONES (UNII: 71B37NR06D)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-254-041 in 1 CARTON
    1120 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2014
    Labeler - Chain Drug Marketing Association (011920774)