Label: SPARMS ORGANIC SPORTS SUNSCREEN- 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 February 5, 2023

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  • SParms Organic Sports Sunscreen

    Package Label

  • INGREDIENTS AND APPEARANCE
    SPARMS ORGANIC SPORTS SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83252-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 kg  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CORIANDER OIL (UNII: 7626GC95E5)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    WATER (UNII: 059QF0KO0R)  
    JOJOBA OIL (UNII: 724GKU717M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HINOKITIOL (UNII: 5MPS47D679)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83252-002-000.07 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/25/2023
    Labeler - Veganic SKN Limited (743536682)
    Establishment
    NameAddressID/FEIBusiness Operations
    Veganic SKN Limited743536682pack(83252-002) , manufacture(83252-002) , label(83252-002)