Label: SURFERSSKIN FACE SUNSCREEN- octocrylene, titanium dioxide, zinc oxide stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 3, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients

    Octocrylene 6.0%

    Titanium Dioxide 3.30%

    Zinc Oxide 14.25%

  • PURPOSE

    Purpose

    Sunscreen

  • INACTIVE INGREDIENT

    Uses

    Helps prevent sunburn

    Higher SPF gives more sunburn protection

    Provides high protection against sunburn

    Regains SPF after 80 minutes of sweating.

  • WARNINGS

    Warnings

    For external use only

    UV exposure from the 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 ad lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Directions

    apply generously 15mins before sun exposure and as needed

    Children under 6 months of age: ask a doctor.

    Reapply as needed or after towel drying, swimming or sweating.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Alumina, Aluminum Stearate, Avocado Oil, Beeswax, C12-15 Alkyl Bezoate, Candellia Wax, Capryllic/capric Triglyceride, Cydomethicone, Fragrance, Hydrogenerated Castor Wax, Isohexadecane, Isopropyl Myristate, Isosteric Acid, Lanolin Anhydrous, Microwax, Polyhidroxystearic Acid, Polyhydroxystearic Acid, PPG-3 Benzyl Ether Myristate, Triethylhexanoin.

  • DESCRIPTION

    New "hands-free" SPF 30+ from SURFERS SKIN, the ultimate face stick sunscreen. The quick no mess sturdy applicator delivers without leaving your hands greasy. THE HANDS-FREE FACE STICK PROVIDES VERY WATER/SWEAT RESISTANT, BROAD SPECTRUM UVA/UVB PROTECTION. Its texture is made up of a new resistant formula that won't run into your eyes.


    To report a serious adverse event, contact 1-800-332-1088

    Expires:

    Lot Number:

    ww.snowskin.co

    DIST. BY Quiver Dist, Bend Oregon, USA 97701

    AS/ANZ STANDARD 2604-1998

    Net Wt. 1.41oz (40g)

  • PRINCIPAL DISPLAY PANEL

    SPF 30+

    very water / sweat resistant

    broad spectrum

    UVA/UVB protection



    Proven in extreme new zealand conditions

    SurfersSkin "face stick" sunscreen

    hands free

    Net Wt. 1.41 oz (40g)

    aminobenzoic acid (PABA)-free

  • PRINCIPAL DISPLAY PANEL

    Surfersskin Face Stick

  • PRINCIPAL DISPLAY PANEL

    Surfersskin Face Stick

  • INGREDIENTS AND APPEARANCE
    SURFERSSKIN FACE SUNSCREEN 
    octocrylene, titanium dioxide, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75916-3025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.3 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE14.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75916-3025-11 in 1 BOX
    140 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/27/2011
    Labeler - Skin Alive, Ltd. (593384746)
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