Label: AWAKEN BY QUALITY CHOICE LONG-LASTING OIL-FREE MOISTURIZER BROAD SPECTRUM SPF 15- avobenzone, octisalate, octocrylene and oxybenzone 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.

View All Sections
  • Active ingredient

    Avobenzone 2.0%

    Octisalate, 5.0%

    Octocrylene, 4.0%

    Oxybenzone, 3.0%

  • 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, carbomer, cetearyl alcohol, ceteareth-20, glycerin, C12-15 alkyl benzoate, glyceryl stearate, PEG-100 stearate, diiosopropyl adipate, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, dimethicone, triethanolamine.

  • Package/Label Principal Display Panel

    Awaken
    by Quality Choice®

    long lasting
    facial moisturizer

    BROAD SPECTRUM
    SPF 15 SUNSCREEN

    Oil free

    Hypoallergenic

    Non-comedogenic

    Dermatologist tested

    *Compare to Neutrogena®
    Oil-Free Moisture Sensitive Skin Ingredients

    4 FL OZ (118 mL)

    Long-Lasting Facial Moisturizer Broad Spectrum SPF 15 Sunscreen penetrates deep into skin to provide instant moisturization and sun protection. Your skin will be left feeling softer, smoother, and look revitalized.

    THE RESULTS

    This light, non-greasy lotion efficiently moisturizes skin for up to 12 hours. The pure formula is quickly absorbed, leaving skin softer and smoother.

    Broad spectrum SPF 15 sunscreen assists in fighting premature aging caused by daily exposure to the sun.

    The oil-free formulation is quickly absorbed so it won’t clog pores leading to skin breakouts.
    Long-Lasting Moisturizer Broad Spectrum SPF15 Sunscreen is:

    •
    Hypoallergenic
    •
    Fragrance-Free
    •
    Alcohol-Free (no drying alcohol)

    DIRECTIONS FOR USE

    Use morning and evening, alone or under make-up.
    Apply over entire face and neck.

    Dermatologist Note:
    Humectants increase the water content in skin without causing shine, clogging pores or smearing make-up. Many oil-free products contain moisturizing ingredients with these humectants properties, making them ideal for oily skin.

    *This product is not manufactured or distributed by Neutrogena®, owner of the registered trademark Neutrogena® Oil-Free Moisture

    SATISFACTION GUARANTEED

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

    Manufactured in Israel
    82026 CD C1

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    AWAKEN BY QUALITY CHOICE LONG-LASTING OIL-FREE MOISTURIZER BROAD SPECTRUM SPF 15 
    avobenzone, octisalate, octocrylene and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-255
    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) OCTOCRYLENE4 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-255-041 in 1 CARTON
    1118 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!