Label: PERFECT TRUTH CC EYE BROAD SPECTRUM SPF 15 OLEHENRIKSEN- avobenzone, homosalate and octocrylene cream

  • NDC Code(s): 51770-110-01, 51770-110-02
  • Packager: Ole Henriksen
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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  • ACTIVE INGREDIENT

    Active Ingredients         Purpose

    Avobenzone 2%           Sunscreen

    Homosalate 5%            Sunscreen

    Octocrylene 1.86%       Sunscreen

    Uses
    helps prevent sunburn

    Keep out of reach of children. If product is swallowed, get medical help or
    contact a Poison Control Center right away.

    Stop use and ask a doctor if rash occurs

    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 product is swallowed, get medical help or
    contact a Poison Control Center right away.

    Directions

     Apply liberally 15 minutes before sun exposure
     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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
     Reapply at least every 2 hours
     Use a water resistant sunscreen if swimming or sweating
     Children under 6 months: Ask a doctor

    Water (Aqua/Eau), Titanium Dioxide, Caprylic/Capric Triglyceride, Propanediol, Cocoglycerides, Glyceryl Stearate, PEG-40 Stearate, Jojoba Esters, Glycerin, Isostearyl, Neopentanoate, Mica, Butyrospermum Parkii (Shea) Butter, Dimethicone, Phenethyl Benzoate, Beeswax, Dimethicone/Vinyl Dimethicone Crosspolymer, Iron Oxides, Cyclopentasiloxane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetyl Phosphate, Isostearyl Hydroxystearate, Stearyl Alcohol, Phenoxyethanol, Cetearyl Alcohol, Tocopheryl Acetate, Acrylates/Dimethicone Copolymer, Imperata Cylindrica Root Extract, Caprylyl Glycol, Chlorphenesin, Silica.

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  • PRINCIPAL DISPLAY PANEL

    carton

    Ole Henriksen

    all skin types/anti-aging

    perfect truth cc eye cream

    broad spectrum SPF 15

    youth defending eye corrector with 5 sources of vitamin C and ferulic acid

    0.25 fl. oz./7 mL

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  • INGREDIENTS AND APPEARANCE
    PERFECT TRUTH CC EYE BROAD SPECTRUM SPF 15  OLEHENRIKSEN
    avobenzone, homosalate, octocrylene cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51770-110
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (AVOBENZONE) AVOBENZONE 2 g  in 100 mL
    HOMOSALATE (HOMOSALATE) HOMOSALATE 5 g  in 100 mL
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 1.86 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    TITANIUM DIOXIDE  
    MEDIUM-CHAIN TRIGLYCERIDES  
    PROPANEDIOL  
    COCO-GLYCERIDES  
    GLYCERYL MONOSTEARATE  
    PEG-40 STEARATE  
    GLYCERIN  
    ISOSTEARYL NEOPENTANOATE  
    MICA  
    SHEA BUTTER  
    DIMETHICONE  
    PHENETHYL BENZOATE  
    YELLOW WAX  
    FERRIC OXIDE RED  
    FERRIC OXIDE YELLOW  
    FERROSOFERRIC OXIDE  
    CYCLOMETHICONE 5  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)  
    CETYL PHOSPHATE  
    ISOSTEARYL HYDROXYSTEARATE  
    STEARYL ALCOHOL  
    PHENOXYETHANOL  
    CETOSTEARYL ALCOHOL  
    .ALPHA.-TOCOPHEROL ACETATE  
    IMPERATA CYLINDRICA ROOT  
    CAPRYLYL GLYCOL  
    CHLORPHENESIN  
    SILICON DIOXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51770-110-02 1 in 1 CARTON
    1 NDC:51770-110-01 7 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 03/27/2013
    Labeler - Ole Henriksen (133369058)
    Registrant - Ole Henriksen (133369058)
    Establishment
    Name Address ID/FEI Business Operations
    Cosway Company, Inc. 620899877 manufacture(51770-110)
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