Label: SPF30 SHEER TOUCH TINTED SUNSCREEN LIGHT - MEDIUM- zinc oxide lotion
SPF30 SHEER TOUCH TINTED SUNSCREEN MEDIUM - DARK- zinc oxide lotion

  • NDC Code(s): 55560-5002-1, 55560-5003-1
  • Packager: Andalou naturals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 12, 2020

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active ingredient

    Zinc Oxide (21.5%)

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

    • if used as directed with other sun protection measures (see Directions) decreases the risk of early skin ageing caused by the sun.
  • Warnings

    For external use only

    • Do not use on damaged or broken skin
    • Keep out of eyes. Rinse with water to remove

    • Stop use and ask a doctor if a rash occurs

    • Keep out of reach of children. If swallowed, get medical help or contact a poison control centre right away.
  • Directions

    Apply liberally 15minutes before sun exposure

    • reapply:
      • after swimming, sweating,
      • immediately after towel drying
      • every 2 hours
    • Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk regularly use a sunscreen with broad spectrum protection value of SPF15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10am to 2pm
      • wear long sleeved shirts, pants, hat and sunglasses.
      • children under 6 months of age ask a doctor.
  • Other information

    Protect this product from excessive heat and direct sun

    • may stain some fabrics.
  • Inactive ingredients

    Aqua/Water/Eau, Isoamyl Laurate, Caprylic/Capric Triglyceride, Sorbitan Stearate, Cetearyl Alcohol, Hydroxypropyl Starch Phosphate, Phenethyl Alcohol, Caprylyl Glycol, Glyceryl Isostearate, Xanthan Gum, Polyhydroxystearic Acid, Cetearyl Glucoside, Sucrose Cocoate, Rosa Canina Fruit Oil, Carthamus Tinctorius (Safflower) Seed Oil, Glycerin, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Sinensis Leaf Extract, Potassium Sorbate, Fragrance (Parfum), CI 77492, CI 77491, CI 77499.

  • Questions?

    Call: AUS: 1300 858 898 CANADA: 1-888-464-6775

  • PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton - LIGHT - MEDIUM

    sukin®
    AUSTRALIAN • NATURAL

    SUNCARE

    • REEF SAFE •
    REEF SAFE

    SPF30

    SHEER TOUCH
    TINTED
    SUNSCREEN

    UVA & UVB
    BROAD SPECTRUM

    LIGHT - MEDIUM

    NO OXYBENZONE

    60mL/2.03 fl oz

    PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton - LIGHT - MEDIUM
  • PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton - MEDIUM - DARK

    sukin®
    AUSTRALIAN • NATURAL

    SUNCARE

    • REEF SAFE •
    REEF SAFE

    SPF30

    SHEER TOUCH
    TINTED
    SUNSCREEN

    UVA & UVB
    BROAD SPECTRUM

    MEDIUM - DARK

    NO OXYBENZONE

    60mL/2.03 fl oz

    PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton - MEDIUM - DARK
  • INGREDIENTS AND APPEARANCE
    SPF30 SHEER TOUCH TINTED SUNSCREEN   LIGHT - MEDIUM
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55560-5002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE215 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    SUCROSE COCOATE (UNII: 3H18P0UK73)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CUCUMBER (UNII: YY7C30VXJT)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55560-5002-11 in 1 CARTON11/01/2020
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34710/08/2020
    SPF30 SHEER TOUCH TINTED SUNSCREEN   MEDIUM - DARK
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55560-5003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE215 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    SUCROSE COCOATE (UNII: 3H18P0UK73)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CUCUMBER (UNII: YY7C30VXJT)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55560-5003-11 in 1 CARTON11/01/2020
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34710/08/2020
    Labeler - Andalou naturals (011472720)
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