DT COLLAGEN (OCTOCRYLENE) CREAM [DT COLLAGEN, INC.]

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DT COLLAGEN (OCTOCRYLENE) CREAM [DT COLLAGEN, INC.]
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NDC 70522-001-01
Set ID 2883b764-0d58-57ad-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager DT Collagen, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    Octocrylane 10%, Homosalate 10%, Octinoxate 7.5%, Octinoxate 5%, Avobenzone 3.5%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • WARNINGS

    For external use only.

    Do not use on damaged or borken skin.

    When using this product: keep out of eyes, rinse eyes with water to remove, stop use and ask a doctor if rash occurs.

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Apply liberally 15 minutes before sun exposure.

    Reapply: after 80 minutes of swimming or sweating, immediatly after towel drying, at least every 2 hours.

    Children under 6 months ask a doctor.

  • Other information

    Do not store in excessive heat or direct sunlight.

  • INACTIVE INGREDIENT

    Aqua, vinyl dimethicone copolymer, shea butter, C13-14 isoparafin, caprylic/capric triglyceride, ceramide2, cetearyl alcohol, cetyl alcohol, cyclomethicone, dimethicone, di=panthenol, ethylhexyl palimitate, ethylhexylglycerin, glycerin, glyceryl stearate, hyaluronic acid, laureth-7, PEG-100, stearate, phenoxyethanol, polyacrylamide, polosorbate 20, propyleneylycol, soluble collagen, tocopheryl acetate, triethanolamine

  • PRINCIPAL DISPLAY PANEL

    DT collagen

  • INGREDIENTS AND APPEARANCE
    DT COLLAGEN 
    octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70522-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE 100 (UNII: RO266O364U)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    .ALPHA.-TOCOTRIENOL (UNII: B6LXL1832Y)  
    TRIETHANOLAMINE OLEATE (UNII: DZ7P3IE35F)  
    CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    PROPYLENE GLYCOL 2-OLEATE (UNII: R3FST8K0ZL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70522-001-0150 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2016
    Labeler - DT Collagen, Inc. (011478279)
    Registrant - DT Collagen (011478279)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source080354456manufacture(70522-001)
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