Label: DAILY FADE- hydroquinone spf15 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 June 3, 2009

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  • ACTIVE INGREDIENT


    Active Ingredients:

    Hydroquinone 2%

    Avobenzone 2%

    Octinoxate 5%

  • PURPOSE


    Purpose:

    Skin Lightener Cream

  • INDICATIONS & USAGE


    Uses:

    For gradual fading of dark (brownish) spots.  This product is not intended for use in the prevention of sunburn.

  • WARNINGS


    Warnings:

    Avoid Contact with eyes.  Children under 12 years of age; Do not use unless directed by a doctor. 

  • STOP USE

    Some users may experience a mild irritation. If skin irritation becomes severe, stop use and consult a doctor.

  • DOSAGE & ADMINISTRATION


    Directions:

    Apply evenly in the morning or as directed by a doctor.  Sun exposure should be limited; the product contains an effective sun protection factor in order to minimize the reoccurrence of skin darking.

  • INACTIVE INGREDIENT


    Other Ingredients:

    Water, Stearic Acid, Hydrogenated Vegetable Oil, Cetyl Alcohol, Coco-Caprylate/Caprate, DEA-Cetyl Phosphate, C12-15 Alkyl Benzoate, Propylene Glycol, Dimethicone, Sodium Palmitoyl Proline, Nymphaea Alba Flower Extract, Polyacrylamide, C13-14 Isoparaffin, Lureth-7, Tocopheryl Acetate, Sodium PCA, Citrus Unshiu Peel Extract, Cellulose Gum, Fragrance, EDTA, Sodium Sulfite, Sodium Methabisulfite, Glycerin, Triethanolamine, Phenoxyethanol, Methylparaben, Propylparaben, Ethylparaben, Butylparaben, Isobutylparaben, Caramel.

  • PRINCIPAL DISPLAY PANEL

    Image of carton FademaxSPF15

  • INGREDIENTS AND APPEARANCE
    DAILY FADE   MAXIMUM STRENGTH SPF15
    hydroquinone spf15 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59735-308
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone 2 g  in 100 g
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone2 g  in 100 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate5 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59735-308-561 in 1 CARTON
    156.8 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35806/03/2009
    Labeler - Biocosmetic Research Labs (078870292)
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