Label: AWAKEN SKIN PERFECTOR BB BROAD SPECTRUM SPF 15 SUNSCREEN LIGHT MEDIUM- octinoxate and titanium dioxide 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 18, 2014

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

  • Active ingredients

    Octinoxate, 4.0%
    Titanium Dioxide, 2.1%

  • 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, talc, C12-15 alkyl benzoate, caprylic/capric triglyceride, potassium cetyl phosphate, cyclopentasiloxane, glyceryl miristate, isononyl isononanoate, behenyl alcohol, mineral oil, glycerin, propylene glycol, microcrystalline cellulose, cellulose gum, phenoxyethanol, ethylhexylglycerin, nylon-12, fragrance, triethanolamine, ammonium acryloyldimethyltaurate/VP copolymer, iron oxides, butylene glycol, allantoin, caffeine, ascorbic acid, disodium EDTA, tocopheryl acetate (vitamin E), BHT, hyaluronic acid.

  • Package/Label Principal Display Panel

    Awaken by Quality Choice®
    BB cream
    light/medium

    Broad Spectrum
    SPF 15 Sunscreen

    Skin perfector

    With vitamin C & mineral pigments

    Renews, brightens, evens tone & hydrates

    Oil free, non-greasy

    *Compare to Garnier® Skin Renew Miracle Skin Perfector B.B. Cream SPF15

    2.5 FL OZ (75 mL)

    This BB Cream Light/Medium Broad Spectrum SPF 15 Sunscreen combines many steps of your daily beauty routine into one.

    It is lightweight, easy to use, and provides almost instant results that you can see and feel. This innovative formula is designed to deeply moisturize and help even skin tone, resulting in a smooth and unblemished appearance.

    The Results
    Skin instantly looks more even-toned, smooth and radiant.

    Radiance is renewed.
    Complexion is brightened.
    Skin tone is evened out and imperfections are blurred.
    24-hour hydration.
    SPF15 sunscreen protects against the harmful effects of the sun.

    Directions For Use
    Gently smooth onto face and neck prior to exposure to the sun.

    Formula Essentials:

    Dermatology tested.
    Non-Comedogenic (won’t clog pores).
    Gentle to skin.
    Non-greasy.

    Why is this product for me?
    Skin discolorations, dullness, blemishes and dryness can be caused by a number of different factors. It is difficult to find one product that will address all these factors at once.

    This product is not manufactured or distributed by Garnier®, owner of the registered trademark Skin Renew

    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
    6A418 CD C1

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    AWAKEN SKIN PERFECTOR BB BROAD SPECTRUM SPF 15 SUNSCREEN LIGHT MEDIUM 
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-252
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TALC (UNII: 7SEV7J4R1U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERYL MYRISTATE (UNII: 6992Y81827)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    NYLON-12 (UNII: 446U8J075B)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CAFFEINE (UNII: 3G6A5W338E)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-252-031 in 1 CARTON
    175 mL in 1 TUBE; 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)