VIVIDLY BRILLIANT PERFECTING (HYDROQUINONE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA]

VIVIDLY BRILLIANT PERFECTING (HYDROQUINONE) LIQUID [AMCOL HEALTH & BEAUTY SOLUTIONS, INC. DBA]
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NDC 68634-051-01
Set ID 081cc08d-d9e9-4140-8c67-9b5fd998a5ff
Category HUMAN OTC DRUG LABEL
Packager AMCOL Health & Beauty Solutions, Inc. DBA
Generic Name
Product Class
Product Number
Application Number PART358A
  • SPL UNCLASSIFIED SECTION

    HBS Code (Labeler): FP60402-50.2
    Distributor: Derma Faith

    Human Prescription Drug
    Active Ingredient: Hydroquinone 4%

    CARTON TEXT

    ________________________________________________________

    vividly brilliant
    perfecting lotion

    derma faith

    50 ml/1.7 fl oz

    vividly brilliant
    perfecting lotion

  • Directions:

    Apply a single pump to face in the evening. If you have never used a retinol product before, begin by limiting use to twice a week, gradually increasing frequency to every other night, and then advancing to each evening or as tolerated. Mild redness, peeling and irritation is expected when using this product.

  • INDICATIONS & USAGE

    Use daily sun protection during use of this product. Avoid getting in eyes. If contact occurs, rinse eyes thoroughly with water.

  • Caution:

    Do not use if you are pregnant, lactating or planning to become pregnant.

    Keep out of reach of children.

    Derma Faith LLC
    5701 W. Slaughter Lane
    A130 #337
    Austin, TX 78749
    Made in the U.S.A.
    www.dermafaith.com
    M050839

    This extra-strength formula features patented MICROSPONGE® Technology to gently, yet effectively help reduce the appearance of dark spots and fine lines.

  • Active Ingredients:

    Hydroquinone 4.0%

  • PURPOSE

  • Inactive Ingredients:

    Water, Caprylic/Capric, Triglyceride, Cetearyl Alcohol, Glycerin, Polysorbate 60, Dimethicone, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, C10-30 Cholesterol/Lanosterol Esters, Cetyl Ricinoleate, Cetyl Alcohol, Benzyl Alcohol, Polyacrylamide, Cetyl Phosphate, Sodium Metabisulfite, TEA-Stearate, Phenoxyethanol, Magnesium Aluminum Silicate, Cyclopentasiloxane, Triethanolamine, C13-14 Isoparaffin, PEG-10 Soy Sterol, Cyclohexasiloxane, Disodium EDTA, Methylparaben, Retinol, Polysorbate 20, Laureth-7, Bisabolol, Ascorbic Acid, Tocopheryl Acetate, BHT, Ascorbyl Palmitate, Propyl Gallate

    ________________________________________________________

    150609

    AMCOL Health & Beauty Solutions, Inc. DBA
    301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com
    lauren.haase@amcol.com

  • Principal Display Panel - Carton Label

    vividly brilliant

    perfecting lotion

    derma
    faith

    50 ml/1.7 fl oz

    Principal Display Panel - Carton Label
  • Principal Display Panel - Bottle Label

    vividly brilliant

    perfecting lotion

    derma
    faith

    50 ml/1.7 fl oz

    Principal Display Panel - Bottle Label
  • INGREDIENTS AND APPEARANCE
    VIVIDLY BRILLIANT PERFECTING 
    hydroquinone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68634-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    hydroquinone (UNII: XV74C1N1AE) (hydroquinone - UNII:XV74C1N1AE) hydroquinone40 g  in 2 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    glycerin (UNII: PDC6A3C0OX)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    dimethicone (UNII: 92RU3N3Y1O)  
    methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q)  
    C10-30 cholesterol/lanosterol esters (UNII: 137SL7IL0Y)  
    cetyl ricinoleate (UNII: 1P677500YD)  
    cetyl alcohol (UNII: 936JST6JCN)  
    benzyl alcohol (UNII: LKG8494WBH)  
    cetyl phosphate (UNII: VT07D6X67O)  
    sodium metabisulfite (UNII: 4VON5FNS3C)  
    trolamine Stearate (UNII: 1J6JM3JE61)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    magnesium aluminum silicate (UNII: 6M3P64V0NC)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    trolamine (UNII: 9O3K93S3TK)  
    C13-14 isoparaffin (UNII: E4F12ROE70)  
    PEG-10 soy sterol (UNII: FG54K98L0Q)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    edetate disodium (UNII: 7FLD91C86K)  
    methylparaben (UNII: A2I8C7HI9T)  
    retinol (UNII: G2SH0XKK91)  
    polysorbate 20 (UNII: 7T1F30V5YH)  
    Laureth-7 (UNII: Z95S6G8201)  
    levomenol (UNII: 24WE03BX2T)  
    ascorbic acid (UNII: PQ6CK8PD0R)  
    .alpha.-tocopherol acetate, DL- (UNII: WR1WPI7EW8)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    propyl gallate (UNII: 8D4SNN7V92)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68634-051-011 in 1 CARTON
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart358A01/01/2015
    Labeler - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMCOL Household & Personal Care872684803MANUFACTURE(68634-051) , PACK(68634-051) , LABEL(68634-051) , ANALYSIS(68634-051)

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