Label: SUN BLOCK SPRARY- sun block sprary spf15 spray

  • 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 15, 2015

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  • ACTIVE INGREDIENT

    Active ingredients--------------purpose

    Ethyl Alcohol 62%------------antiseptic

  • PURPOSE

    Uses:
    Reduces bacteria on the skin. Recommended for repeated use.

  • WARNINGS

    Warnings:

    For external use only.Flammable:Keep away from heat for flame.Do no use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • INDICATIONS & USAGE

    Directions:

    Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry.

  • DOSAGE & ADMINISTRATION

    Other Information

    Do not store above 110F(43C) May discolor certain fabric or surfaces. Harmful to wood finishes and plastics.


  • KEEP OUT OF REACH OF CHILDREN

    Children under 6 years of age should be super vised when using this product.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water,Glycerin,Isopropyl Myristate, Propylene Glycol,Tocopheryl Acetate, Aminomethyl Propanol, Carbomer, Fragrance

  • PRINCIPAL DISPLAY PANEL

    image of sun block lotion

  • INGREDIENTS AND APPEARANCE
    SUN BLOCK SPRARY 
    sun block sprary spf15 spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-215
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate3 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE (UNII: NMQ347994Z) 6 g  in 100 g
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF) 1 g  in 100 g
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U) 0.03 g  in 100 g
    CARBOMER 1342 (UNII: 809Y72KV36) 0.2 g  in 100 g
    Propylene Glycol (UNII: 6DC9Q167V3) 8 g  in 100 g
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.5 g  in 100 g
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) 0.07 g  in 100 g
    METHYLPARABEN (UNII: A2I8C7HI9T) 0.15 g  in 100 g
    WATER (UNII: 059QF0KO0R) 75.05 g  in 100 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-215-07100 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/20/2015
    Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD529334491manufacture(47993-215)
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