Label: SUNBLOCK CREAM- zinc oxide, octisalate, titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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 August 31, 2020

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  • PRINCIPAL DISPLAY PANEL

    50g in a bottle NDC: 80376-001-01

    50g Label

  • INGREDIENTS AND APPEARANCE
    SUNBLOCK CREAM 
    zinc oxide, octisalate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80376-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE9 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) 3 g  in 100 g
    WATER (UNII: 059QF0KO0R) 45.8 g  in 100 g
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.2 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80376-001-0150 g in 1 BOTTLE; Type 0: Not a Combination Product08/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/31/2020
    Labeler - Zhuhai Yasha Medical Instrument Co., Ltd. (544515023)