Label: SUNSCREEN SPF 30- avobenzone,octinoxate, octisalate, oxybenzone stick

  • 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 September 1, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient

    Avobenzone 2.0 percent, Octinoxate 7.5 percent, Octisalate 5.0 percent

    Oxybenzone 6.0 percent...............................................................Sunscreen


  • PURPOSE

    Uses   Helps prevent sunburn

  • WARNINGS

    Warnings

    Skin Cancer/Skin Aging Alert, Spending time in the sun

    increase your risk of skin cancer and early skin aging.

    This products has been shown only to prevent sunburn only to prevent sunburn,

    not skin cancer or early skin aging.

    For external use only

  • STOP USE

    Do not use on damaged or broken skin

    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.


  • DOSAGE & ADMINISTRATION

    Directions. Apply generously  and evenly before sun exposure.

    Reapply as needed or after towel drying, swimming, or swea

    -ting. Ask doctor before using on children under 6 months.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Bee wax,  Ozoceriate, Vaseline, Cetearyl Alcohol,
    Hydrogenated Coco-glycerides, Carnauba Wax,
    Tocopheryl acetate (VE), Fragrance.

  • PRINCIPAL DISPLAY PANEL

    Other information

    Protect this product from excessive heat and direct sun.


  • DESCRIPTION

    Distributed by Tekweld Inc.

    180 Central Avenue

    FARMINGDALE, NY 11735



    Made in China                                MFG:90807


  • PRINCIPAL DISPLAY PANEL

                SPF

                  30

             SunScreen

                 Stick

            UVA and  UVB

           PROTECTION



    Active Ingredients

    Avobenzone 2.0 percent, Octinoxate 7.5 percent, Octisalate 5.0 percent

    Oxybenzone 6.0 percent............................................................... Sunscreen





                   0.6 OZ(17g)


        

  • PRINCIPAL DISPLAY PANEL

    SunscreenStick

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN SPF 30 
    avobenzone,octinoxate, octisalate, oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31190-700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.0 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CERESIN (UNII: Q1LS2UJO3A)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:31190-700-171 in 1 CARTON
    117 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/01/2011
    Labeler - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)
    Registrant - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Kejing Cleaning Products Co., Ltd.526877847manufacture
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