Label: COLLAGEN GLOW MINERAL SUNSCREEN SPF 50- zinc oxide lotion

  • NDC Code(s): 81104-103-11, 81104-103-12, 81104-103-13
  • Packager: NAKED SUNDAYS PTY LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 31, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ZINC OXIDE 22.75%

    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.
    • CONTAINS SODIUM BENZOATE.

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

  • 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 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

    CETEARYL GLUCOSIDE, CETOSTEARYL ALCOHOL, COCO-CAPRYLATE, DISODIUM EDETATE, GLUCONOLACTONE, HYDROLYZED ADANSONIA DIGITATA SEED EXTRACT, HYDROLYZED RICE PROTEIN, HYDROLYZED SOY PROTEIN, ISOSTEARIC ACID, CAPRIC TRIGLYCERIDES, OCTYLDODECANOL, PEG-30 DIPOLYHYDROXYSTEARATE, POLYGLYCERYL-3 POLYRICINOLEATE, PROLINE, WATER (AQUA), SODIUM BENZOATE, SODIUM CHLORIDE.

  • OTHER INFORMATION

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

  • PRINCIPAL DISPLAY PANEL

    123478

  • INGREDIENTS AND APPEARANCE
    COLLAGEN GLOW MINERAL SUNSCREEN  SPF 50
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81104-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION22.75 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    ADANSONIA DIGITATA SEED (UNII: 2936P60TPX)  
    ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81104-103-1150 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2020
    2NDC:81104-103-1220 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2020
    3NDC:81104-103-1380 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/01/2020
    Labeler - NAKED SUNDAYS PTY LTD (746918845)