Label: CORREWAY SUNSCREEN (WATERPROOF)- 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 April 23, 2010

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  • ACTIVE INGREDIENT

    Zinc Oxide, Octinoxate, Enzacamene, Avobenzone

    Ask Doctor

    Stop use and ask a doctor if rash or irritation develops and lasts.
    Children under 6 months of age: ask a doctor;
  • Warning

    For external use only;
    Avoid contact with eyes;
    Stop use and ask a doctor if rash or irritation develops and lasts;
    Keep out of reach of children.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children
  • PURPOSE

    Helps prevent sunburn;
    Higher SPF gives more sunburn protection;
    Retain SPF after 40 minutes activity in the water;
    Rinse with soap to remove.
  • STOP USE

    Stop use and ask a doctor if rash or irritation develops and lasts.
  • WHEN USING

    Apply liberally before skin exposure;
    Reapply as needed after swimming.
  • PRINCIPAL DISPLAY PANEL

    image of tube label
  • INGREDIENTS AND APPEARANCE
    CORREWAY SUNSCREEN (WATERPROOF) 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50600-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide80 mg  in 1 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate70 mg  in 1 g
    Enzacamene (UNII: 8I3XWY40L9) (Enzacamene - UNII:8I3XWY40L9) Enzacamene35 mg  in 1 g
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Ceteth-10 (UNII: LF9X1PN3XJ)  
    Polyoxyl 100 Stearate (UNII: YD01N1999R)  
    Sorbitan Monooleate (UNII: 06XEA2VD56)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Diglycol Stearate (UNII: 94YQ11Y95F)  
    Magnesium Sulfate Heptahydrate (UNII: SK47B8698T)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Diazolidinylurea (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50600-003-0142.6 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/23/2010
    Labeler - Ningbo Correway Cosmetics Co., Ltd. (529544313)
    Registrant - Ningbo Correway Cosmetics Co., Ltd. (529544313)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Correway Cosmetics Co., Ltd.529544313manufacture
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