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

  • 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 January 31, 2011

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  • Active Ingredients

    Active Ingredients

    Octinoxate 7.5%

    Oxybenzone 3.45%

    Titanium Dioxide 1%

    Zinc Oxide 1.95%

  • Purpose

    Purpose

    Sunscreen

  • Uses

    Helps prevent Sunburn

    Higher SPF gives more sunburn protection

    Provides high protection against sunburn

    Retains SPF after 80 minutes of swimming

  • Warnings

    Warnings

    For external use only

    UV exposure from the sun increases the risk of skin cancer, premature 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 this product

    When using this product

    Keep out of eyes. Rinse with water to remove.

  • 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

  • Directions

    Apply generously 15 min 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 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

  • DESCRIPTION

    Surfersskin 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 runinto your eyes and give you up to 80 mins protection in the water.


    Made in NZ

    Skin alive



    Expires:
    Lot Number

    www.surfersskin.co

    DIST. BY: Quiver Dist., Bend Oregon, USA 97701

    AS/ANZ STANDARD 2604-1998

    4.2 fl oz (125ml)



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

  • PRINCIPAL DISPLAY PANEL

    spf 30+

    very water/sweat resistant

    broad spectrum

    UVA/UVB Protection

    Surfersskin Sunscreen

    Proven in Extreme New Zealand conditions

    4.2 fl oz (125ml)

    manuka honey UMF 18

    CONTAINS NO NANOPARTICLES - AMINOBENZOIC ACID (PABA)-FREE

  • PRINCIPAL DISPLAY PANEL

    Surfersskin Sunscreen

  • PRINCIPAL DISPLAY PANEL

    Surfersskin Sunscreen

  • INGREDIENTS AND APPEARANCE
    SURFERS SKIN SUNSCREEN 
    octinoxate, oxybenzone, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75916-4019
    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 OXIDE - UNII:SOI2LOH54Z) 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)  
    HONEY (UNII: Y9H1V576FH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75916-4019-4125 mL in 1 TUBE
    2NDC:75916-4019-11 in 1 BOX
    240 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/31/2011
    Labeler - Skin Alive, Ltd. (593384746)
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