5298 SUNSCREEN (OCTOCRYLENE, TITANIUM DIOXIDE, OCTISALATE) LOTION [INNOVATION SPECIALTIES]

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5298 SUNSCREEN (OCTOCRYLENE, TITANIUM DIOXIDE, OCTISALATE) LOTION [INNOVATION SPECIALTIES]
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NDC 76138-215-02
Set ID 07e8b370-0233-419a-9fea-e38ee73baabb
Category HUMAN OTC DRUG LABEL
Packager Innovation Specialties
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active Ingredient

    Octocrylene 9%

    Titanium dioxide 7%

    Octisalate 5%

  • Purpose

    Sunscreen

  • Uses

    •helps prevent sunburn
    •if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • 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

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

  • Directions

    •apply liberally 15minutes before sun exposure
    •reapply:
      •after 40 minutes of swimming or sweating
      •immediately after towel drying
      •at least every 2 hours
    •Sun Protection Measure. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 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
      •children under 6 months: Ask a doctor

  • Inactive ingredients

    Water, C12-15 Alkyl Benzoate, Isopropyl Myristate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, CETETH-25, Glyceryl Stearate, Glycerin, Dmdm Hydantoin, Methyl Paraben, Propylparaben, Fragrance

  • Other information

    •protect this product from excessive heat and direct sun

  • QUESTIONS

    NDC (76138-215-02) DIN 02448890
    Made in China for Innovation line.
    Los Angeles CA 90066
    Questions or Comments?
    Call:1-855-755-5346

  • SPL UNCLASSIFIED SECTION

    Sunscreen Lotion SPF30

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    5298 SUNSCREEN 
    octocrylene, titanium dioxide, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76138-215
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-25 (UNII: 5KLY4IOG20)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76138-215-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2018
    Labeler - Innovation Specialties (030837314)
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