5414 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [INNOVATION SPECIALTIES]

5414 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [INNOVATION SPECIALTIES]
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NDC 76138-218-01
Set ID baac8e11-cd39-46e6-b013-3d3490512c5e
Category HUMAN OTC DRUG LABEL
Packager Innovation Specialties
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

  • Active ingredient:

    Avobenzone 3%

    Homosalate 10%

    Octocrylene 10%

    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 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, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

  • Other information

    • protect this product from excessive heat and direct sun
  • Questions?

    HOTLINE # 1-855-755 5346
    NPN# 80062390

  • SPL UNCLASSIFIED SECTION

    1FL OZ (30ML)
    Made in China For Innovation Line Los Angeles,
    CA 90066
    Product # 5414

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    5414 SUNSCREEN 
    avobenzone, homosalate, octocrylene, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76138-218
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76138-218-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/20/2018
    Labeler - Innovation Specialties (030837314)

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