Label: DT COLLAGEN- octocrylene cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 15, 2017

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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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