Label: AGELESS TOTAL REJUVENATING HAND- octinoxate, octisalate, avobenzone, octocrylene cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 1, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients:

    1. Octinoxate (Ethylhexyl Methoxycinnamate) 7.5%

    2. Octisalate (Ethylhexyl Salicylate) 5.0%

    3. Butyl Methoxydibenzoylmethane (Parsol 1789, Avobenzone) 2.0%

    4. Octocrylene 2.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water (Aqua), Caprylic/Capric Triglyceride (and) Linoleic acid (and) Glycine soja (Soybean) sterols (and) phospholepids, Caprylic/Capric Triglyceride (and) Diacetyl Boldine (Lumiskin), Kojic acid, Glycyrrhiza glabba (Licorice) root extract, Ubiquinone (Coenzyme Q10), Olea europea (Olive) leaf extract, Mushroom extract (Tricholoma matsutake singer)-enzyme-alcohol, Archtostaphylos uva ursi (Bearberry) leaf extract, Morus alba (Mulberry) leaf extract, Saccharomyces/Xylinum Black Tea Ferment-Glycerin-Hydroxyethylcellulose (Kombuchka), Dimethicone, Brassica compestris / Aleuritis fordi oil copolymer, Sodium Hyaluronate Crosspolymer, Phenoxyethanol and Caprylyl Glycol and Ethylhexyl Glycerin and Hexylene Glycol, Hydrolyzed Wheat Protein and Hydrolyzed Wheat Starch, Limnanthes alba (Meadowfoam) seed oil, PEG-60 Maracuja glycerides, Biosaccharide Gum-1, Portulac oleracea extract, Xanthan gum, Tetrahexyldecyl Ascorbate, Disodium EDTA.

  • PRINCIPAL DISPLAY PANEL

    Other information on back of the tube:

    (Claims)

    A Daily, super hydrating UVA/UVB broad spectrum moisturizer for the hands. Diminishes age spots with a blend of natural skin lightening agents, protects against harmful effects of the sun and builds up collagen to restore youthful skin. Contains eoenzyme Q10 and other anti-oxidants to fight against free radicals and environmental danmage.

    Indications:

    Signs of aging skin, age spots, dry, dehydrated skin.

    Directions:

    Apply daily for maximum protection and moisture. Reapply throughout the day and while exposed to the sun.

    Reapply while exposed to Sun.

    Distributor:

    Image International

    Palm Beach, FL 33411 USA

    Image of the Product:

    AGELESS Total Rejuvenating Hand Creme

    Image of the Product

  • INGREDIENTS AND APPEARANCE
    AGELESS TOTAL REJUVENATING HAND  
    octinoxate, octisalate, avobenzone, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4036-156.7 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2010
    Labeler - Allure Labs, Inc. (926831603)