5283 SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LOTION [INNOVATION SPECIALTIES]

5283 SUNSCREEN (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LOTION [INNOVATION SPECIALTIES]
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NDC 76138-205-01
Set ID 2cd546eb-33a8-4be5-97e0-bd3ff07cf87f
Category HUMAN OTC DRUG LABEL
Packager Innovation Specialties
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

  • Active Ingredient

    Octinoxate          7.5%

    Octisalate           2.0%

    Oxybenzone       4.0%

    Titanium dioxide  2.5%

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

  • ​Directions

    •apply liberally 15 minutes 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, Cetearyl Alcohol, Glycerin, Glyceryl Stearate, Myristyl Propionate, Propylene Glycol Dioleate, Ceteareth-25, PEG-9 Dimethicone, Xanthan Gum, Disodium EDTA, Fragrance.

  • ​Other information

    •protect this product from excessive heat and direct sun

  • QUESTIONS

     DIN 02448890

    Questions or Comments? Made in China

    for Innovation line. Los Angeles CA 90066

    Questions ? Call: 1-855-755-5346​​​​           

  • SPL UNCLASSIFIED SECTION

    Broad Spectrum SPF30 Lotion

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    5283 SUNSCREEN 
    octinoxate, octisalate, oxybenzone, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76138-205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MYRISTYL PROPIONATE (UNII: P59053E7NJ)  
    PROPYLENE GLYCOL DIOLEATE (UNII: 84T0LSN7U6)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    PEG-9 DIMETHICONE (400 CST) (UNII: 9OZ27X065D)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCOCONUTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76138-205-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/15/2017
    Labeler - Innovation Specialties (030837314)

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