Label: NAKED SUNDAYS COLLAGEN GLOW 100% MINERAL SUNSCREEN SPF 50- zinc oxide liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 29, 2024

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  • ACTIVE INGREDIENTS

    Active Ingredients:
    Zinc Oxide 22.75 %

    Purpose

    Sunscreen

  • USES

    Use:
    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

    Warnings: For external use only.
    Skin Cancer/Skin Aging Alert: Spending time in the
    sun increases your risk of skin cancer and early skin
    aging. This product has been shown only to help
    prevent sunburn, not skin cancer or early skin aging
    Do not use on damaged or broken skin. 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 or contact a Poison
    Control Center right away.

    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

    Inactive Ingredients:
    Aqua, Coco-Caprylate/Caprate, Octyldodecanol,
    Caprylic/Capric Triglyceride, PEG-30
    Dipolyhydroxystearate, Glycerin, Cetearyl alcohol,
    Polyglyceryl-3 Polyricinoleate, Citrullus Lanatus
    (Watermelon) Seed Oil, Disodium EDTA, Sodium
    chloride, Xanthan Gum, Gluconolactone, Isostearic
    acid, Cetearyl glucoside, Sodium benzoate,
    Hydrolyzed Soy Protein, Rice amino acids, Calcium
    Gluconate, Proline, Hydrolyzed Adansonia Digitata
    Seed Extract, Iron Oxides.

  • OTHER INFORMATION

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

  • USER SAFETY WARNINGS

    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 10AM to 2PM
    Wear long-sleeved shirts, pants, hats, and sunglasses

  • directions

    Directions:
    Apply generously 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 6 months of age: Ask a doctor.

  • Label

    1

  • INGREDIENTS AND APPEARANCE
    NAKED SUNDAYS COLLAGEN GLOW 100% MINERAL SUNSCREEN  SPF 50
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81104-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE22.75 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    WATERMELON SEED OIL (UNII: L33J06UQTT)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ADANSONIA DIGITATA SEED (UNII: 2936P60TPX)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    AMINO ACIDS, RICE (UNII: 5ET1T25H82)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81104-002-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/06/2023
    Labeler - NAKED SUNDAYS PTY LTD (746918845)
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