TRUTH REVEALED SUPER CREME SPF 15 OLE HENRIKSEN (OCTINOXATE, AVOBENZONE, OXYBENZONE, OCTOCRYLENE) CREAM [OLE HENRIKSEN]

TRUTH REVEALED SUPER CREME SPF 15 OLE HENRIKSEN (OCTINOXATE, AVOBENZONE, OXYBENZONE, OCTOCRYLENE) CREAM [OLE HENRIKSEN]
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NDC 51770-001-01, 51770-001-02
Set ID e08e0173-9c06-45ff-a884-b89429e91390
Category HUMAN OTC DRUG LABEL
Packager Ole Henriksen
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient                Purpose

    Octinoxate  7.5%               Sunscreen
    Avobenzone 2.0%              Sunscreen
    Oxybenzone 2.0%              Sunscreen
    Octocrylene 1.9%               Sunscreen

    Uses:

    Helps prevent sunburn.

    Higher SPF gives more sunburn protection.

    Keep out of reach of children

    Stop use and ask a doctor if rash or irritation develops and lasts

    Warnings

    For external use only

    When using this product keep out of eyes. Rinse with water to remove.

    If swallowed, get immediate medical help or contact a poison control center right away.

    Directions

    Massage into skin in upward motion, outward circular motions

    For children under 6 months, ask a doctor.

    Inactive Ingredients

    Water (Aqua,Eau), cocoglycerides, Glycerin, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Palmitoyl Tripeptide-5, Algae Extract, Pullulan, Chondrus Chrispus (Carrageenan), Plukenetia Volubilis Seed Oil, Schinus Terebinthifolius Seed Extract, Tetrahexyldecyl Ascorbate, calcium Ascorbate, Sodium Hyaluronate, Chamomilla Recutita (Matricaria) Flower Extract, Daucus Carota Sativa (Carrot) Extract, Corylus Avellana (Hazelnut) extract, Avena Sativa (Oat) Meal Extract. Vaccinum Myrtillus Extract, Saccharum Officinarum (Sugar Cane) Extract, Acer Saccharinum (Sugar Maple) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Medica Limonium (Lemon) Fruit Extract, Bisabolol, Allantoin, Tocopheryl Acetate, Carbomer, Ceteareth-20, Aminomethyl Propanol, sodium Phytate, Citric Acid, Polyacrylate-13/polyisobutene/polysorbate 20, Phenoxy ethanol, Ethylhexylglycerin, Potassium Sorbate, Fragrance (Parfum)

  • PRINCIPAL DISPLAY PANEL

    image of carton

    Image of jar label

    Ole Henriksen

    All skin types/anti-aging

    Truth Revealed Super Creme with SPF 15

    Net. Wt. 1.7 oz/ 50g

  • INGREDIENTS AND APPEARANCE
    TRUTH REVEALED SUPER CREME SPF 15  OLE HENRIKSEN
    octinoxate, avobenzone, oxybenzone, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51770-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    CALCIUM ASCORBATE (UNII: 183E4W213W)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CARROT (UNII: L56Z1JK48B)  
    AVENA SATIVA LEAF (UNII: 206PI19V7R)  
    VACCINIUM MYRTILLUS LEAF (UNII: Y4U591OU70)  
    SUCROSE (UNII: C151H8M554)  
    ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC)  
    ORANGE (UNII: 5EVU04N5QU)  
    LEMON (UNII: 24RS0A988O)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER 934 (UNII: Z135WT9208)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PHYTIC ACID (UNII: 7IGF0S7R8I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51770-001-021 in 1 PACKAGE
    1NDC:51770-001-0150 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/15/2010
    Labeler - Ole Henriksen (133369058)
    Registrant - Ole Henriksen (133369058)
    Establishment
    NameAddressID/FEIBusiness Operations
    HB GORDON MANUFACTURING INC008328619manufacture(51770-001)

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