Label: SNOWSKIN SUNSCREEN- octinoxate, oxybenzone, titanium dioxide, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

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 January 5, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients

    Octinoxate, 7.5%

    Oxybenzone, 3.45%

    Titanium Dioxide, 1%

    Zinc Oxide 1.95%


  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses

    Helps prevent sunburn

    Higher SPF gives more sunburn protection

    Provides high protection against sunburn

    Retains SPF after 80 minutes of sweating

  • WARNINGS


    Warnings

    For external use only.

    UV exposure fromt he sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.


  • WHEN USING

    When using this product

    Keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if

    irritation occurs or rash develops and lasts.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply generously 15mins before sun exposure and as needed.

    Children under 6months of age: ask a doctor

    Reapply as needed or after towel drying, swimming or sweating

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Aloe Vera Gel, Caprylic/Capric Triglyceride, Cetearyl alcohol, Cyclomethicone, Deionised water, Fragrence, Glyceryl Monostearate, Phenoxyethanol, Polysorbate 60, PVP/Ejosene, Retinol Palmitate, Sorbitan Monostearate, Tocopherol Acetate, UMF 18 Manuka Honey

  • PRINCIPAL DISPLAY PANEL

    spf30+

    Very water/sweat resistant

    broad spectrum

    UVA/UVB



    SNOWSKIN Sunscreen

    Proven in Extreme New Zealand conditions

    4.2 fl oz (125 ml)

    manuka honey UMF 18

    contains no nanoparticles - Aminobenzoic acid (PABA) Free



    Snowskin SPF 30+ Sunscreen, Very water/sweat resistant, broad spectrum, UVA/UVB Protection. keep your "Skin alive" with this non-greasy sweat-resistant formula that won't run into your eyes, leaving you free to focus on what really  matters. Whether you're up on the hill or deep in the trees, Snowskin offers great protection from the elements.



    Expires:

    Lot Number:

    www.snowskin.co

    DIST BY Quiver Dist., Bend Oregon, USA 97701

    MADE IN NZ

  • PRINCIPAL DISPLAY PANEL

    Snowskin Sunscreen

  • PRINCIPAL DISPLAY PANEL

    Snowskin Sunscreen2

  • INGREDIENTS AND APPEARANCE
    SNOWSKIN SUNSCREEN 
    octinoxate, oxybenzone, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75916-4018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.45 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE1.95 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75916-4018-4125 mL in 1 TUBE
    2NDC:75916-4018-140 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/05/2011
    Labeler - Skin Alive, Ltd. (593384746)
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