Label: GOLFERS SKIN BROAD SPECTRUM SPF 30 PLUS SUNSCREEN- octinoxate, oxybenzone, titanium dioxide, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated January 13, 2015

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  • Golfers Skin Broad Spectrum SPF 30+ Sunscreen


  • Active Ingredients

    Octinoxate 7.5%

    Oxybenzone 3.45%

    Titanium Dioxide 1%

    Zinc Oxide 1.95%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevents sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • Warnings

    For external use only

  • 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.

  • Directions

    Apply generously 15 mins before sun exposure.
    Reapply:

        * After 40 minutes of swimming  or sweating.
        * Immediately after towel drying
        * At least every 2 hours

    Sun Protections Measure. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use and sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:

        * Limit time in the sun, especially from 10am-2pm
        * Wear long-sleeve shirts, pants, hats and sunglasses
        * Children under 6 months: Ask a Doctor



  • Inactive Ingredients

    Aloe Vera Gel, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cyclomethicone, Deionised Water, Fragrance, Glyceryl Monostearate, Phenoxyethanol, Polysorbate 60, PVP ejcosene, Retinol Palminate, Sorbitan Monostearate, Tocopherol Acetate, UMF 18 Manuka Honey

  • PRINCIPAL DISPLAY PANEL

    spf 30+

    very water/sweat resistant

    broad spectrum

    UVA/UVB Protection

    Golfersskin Sunscreen

    Proven in Extreme New Zealand conditions


    manuka honey UMF 18

    CONTAINS NO NANOPARTICLES - AMINOBENZOIC ACID (PABA)-FREE

  • Representative Product Labeling

    GolfersSkin

  • INGREDIENTS AND APPEARANCE
    GOLFERS SKIN BROAD SPECTRUM SPF 30 PLUS SUNSCREEN  
    octinoxate, oxybenzone, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75916-4020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE34.5 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19.5 mg  in 1 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)  
    HONEY (UNII: Y9H1V576FH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75916-4020-4125 mL in 1 TUBE
    2NDC:75916-4020-11 in 1 BOX
    240 mL in 1 TUBE
    3NDC:75916-4020-31000 mL in 1 BOTTLE
    4NDC:75916-4020-52000 mL in 1 BOTTLE
    5NDC:75916-4020-25 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/31/2011
    Labeler - Skin Alive, Ltd. (593384746)
    Registrant - Skin Alive, Ltd. (593384746)
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