Label: HYDRATING GLOW MIST SPF 50- avobenzone, octisalate, octocrylene spray

  • NDC Code(s): 81104-102-11, 81104-102-12, 81104-102-13, 81104-102-14
  • Packager: NAKED SUNDAYS PTY LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2023

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  • ACTIVE INGREDIENTS

    Avobenzone 3%

    Homosalate 10%

    Octilsalate 5%

    Octocrylene 8%

    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 ageing 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: If product is swallowed, get medical help.

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

    DIRECTIONS

    • SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE.
    • Reapply after 80 minutes of swimming or sweating.
    • Reapply immediately after towel drying.
    • Reapply at least every 2 hours.
    • Children under 3 years of age: Ask a doctor.

    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 10.00AM - 2.00PM
    • Wear long-sleeved shirts, pants, hats, and sunglasses
  • INACTIVE INGREDIENTS

    Butyloctyl Salicylate, D-Alpha-tocopheryl acetate, Ethanol, Fragrance, Hyaluronic acid, Terminalia Ferdinandiana (Kakadu Plum), Citrulius lanatus fruit extract (Watermelon).

  • OTHER INFORMATION

    Protect the product in this container from excessive heat and direct sun.

  • Label

    1234

  • INGREDIENTS AND APPEARANCE
    HYDRATING GLOW MIST  SPF 50
    avobenzone, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81104-102
    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
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    WATERMELON (UNII: 231473QB6R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81104-102-1250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2022
    2NDC:81104-102-1430 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/07/2023
    3NDC:81104-102-1375 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/07/2023
    4NDC:81104-102-11100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/07/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/01/2020
    Labeler - NAKED SUNDAYS PTY LTD (746918845)
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