Label: CARING MILL KIDS SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 12, 2024

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  • Drug Facts

  • Active ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 5%

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    For external use only

    Flammable:Do not use near heat, flame, or while smoking

    Do not use on

    damaged or broken skin

    when using this product

    • keep away from face to avoid breathing it
    • keep out of eyes. Rinse with water to remove.
    • Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
    • Do not store at temperatures above 120°F

    Stop use and ask a doctor if

    rash occurs

    Keep out of reach of children.

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

  • Directions

    • Shake well before each use
    • Spray liberally and spread evenly by hand 15 minutes before sun exposure 
    • Hold container 4 to 6 inches from the skin to apply 
    • Do not spray directly into face. Spray on hands then apply to face. 
    • Do not apply in windy conditions 
    • Use in a well-ventilated area
    • Reapply 
    • After 80 minutes of swimming or sweating
    • Immediateky after towel drying 
    • At least every 2 hours 
    • Sun Protection Measures.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 value of 15 or 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
  • Other information

    Protect this product from excessive heat and direct sun. Store between 68°F to 77°F (20°C to 25°C). May stain or damage some fabrics or surfaces.

  • Inactive ingredients

    Alcohol(45%), Neopentyl Glycol Diheptanoate, C12-C15 Alkyl Benzoate, Butylene Glycol Dicaprylate/Dicaprate, Acrylates/Octylacrylamide Copolymer, Fragrance, Ascorbyl Palmitate

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    CARING MILL KIDS SUNSCREEN SPF 50 
    avobenzone, homosalate, octisalate, liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81522-954
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ALCOHOL (UNII: 3K9958V90M)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81522-954-01162 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/20/2024
    Labeler - FSA Store Inc. (049283340)
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