Label: AWAKEN BY QUALITY CHOICE ANTI-WRINKLE AND FIRMING MOISTURIZER DAY BROAD SPECTRUM SPF18 SUNSCREEN- avobenzone, octisalate and octocrylene 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 September 30, 2014

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

  • Active ingredient

    Avobenzone, 2.0%

    Octisalate, 5.0%

    Octocrylene, 5.0%

  • 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, cyclohexasiloxane, glycerin, titanium dioxide, glyceryl stearate, PEG-100 stearate, beeswax, myristyl myristate, stearic acid, palmitic acid, polyglyceryl-10 pentastearate, behenyl alcohol, sodium steroyl lactylate, tocopheryl acetate (vitamin E), butylene glycol, carbomer, polysorbate 20, palmitoyl tripeptide-1, palmitoyl tetrapeptide-7, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, cetyl alcohol, stearyl alcohol, hydrolyzed soy protein, dipalmitoyl hydroxyproline, fragrance, triethanolamine, glycine soja (soybean) protein, xanthan gum, retinyl palmitate (vitamin A), phenoxyethanol, PEG-20 stearate, potassium sorbate, sodium benzoate, phenethyl alcohol, alcohol denat., chlorphenesin.

  • Package/Label Principal Display Panel

    Awaken
    by Quality Choice®

    anti-wrinkle
    & firming
    moisturizer

    BROAD SPECTRUM
    SPF 18 SUNSCREEN

    Day cream with sunscreen

    With encapsulated pro-vitamin A
    & Matrixyl™ & Sepilift™

    *Compare to L’Oreal® Advanced Revitalift® Complete Day Cream SPF18 ingredients

    NET WT 1.7 FL OZ (48 g)

    Advanced Anti-Wrinkle Action: Encapsulated Pro-Vitamin A and Sepilift™ will hasten skin renewal, reducing the amount of fine lines and wrinkles and their depth. Results can be seen in just two weeks. The new technology will continually act to help fight the signs of aging.

    Innovative Firming: Matrixyl™ has proven to show renewed elastin and collagen fibers. Skin’s surface is remodeled, becoming more resilient and toned.

    Continuous Moisturization & Skin Protection: Provides 24 hour moisturization to soothe dry skin. Broad spectrum UVA/UVB SPF18 protects the skin and prevents skin damage by UV exposure.

    THE RESULTS

    Skin’s elasticity is improved. Visible reduction of wrinkles and skin looks smoother, firmer skin.

    DIRECTIONS FOR USE

    Every day, smooth gently onto face and neck until thoroughly absorbed. Use in the AM, alone or under makeup.

    Matrixyl™ is a registered trademark owned by Sederma.

    Sepilift™ is a registered trademark owned by Seppic.

    Now experience the advanced actions against the signs of skin aging. New Anti-Wrinkle & Firming Moisturizer Broad Spectrum SPF18 Sunscreen, with effective encapsulated Pro-Vitamin A, Matrixyl™ and Sepilift™ will increase cell turnover, reduce wrinkles, firm the skin, and provide 24 hour moisturization.

    FORMULA ESSENTIALS

    UV SPF18 sunscreen
    Non-Comedogenic
    Dermatologist tested for gentleness
    Non-greasy

    *This product is not manufactured or distrubted by L’Oreal®, owner of the registered trademark Revitalift®.

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

    SATISFACTION GUARANTEED

    Manufactured in ISRAEL
    37815 CD C1

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    AWAKEN BY QUALITY CHOICE ANTI-WRINKLE AND FIRMING MOISTURIZER DAY BROAD SPECTRUM SPF18 SUNSCREEN 
    avobenzone, octisalate and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-251
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-20 STEARATE (UNII: NBX892EA57)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    ALCOHOL (UNII: 3K9958V90M)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-251-021 in 1 CARTON
    148 g in 1 JAR; 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)