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

  • Category: HUMAN OTC DRUG LABEL

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 March 27, 2013

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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.

  • 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

  • INGREDIENTS AND APPEARANCE
    PERFECT TRUTH CC EYE BROAD SPECTRUM SPF 15  OLEHENRIKSEN
    avobenzone, homosalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51770-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.86 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    MICA (UNII: V8A1AW0880)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    ISOSTEARYL HYDROXYSTEARATE (UNII: F7540880P0)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51770-110-021 in 1 CARTON
    1NDC:51770-110-017 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/27/2013
    Labeler - Ole Henriksen (133369058)
    Registrant - Ole Henriksen (133369058)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway Company, Inc.620899877manufacture(51770-110)
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