Label: SPARMS ORGANIC KIDS 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 Kids Sunscreen

    Package Label

  • INGREDIENTS AND APPEARANCE
    SPARMS ORGANIC KIDS SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83252-003
    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
    XANTHAN GUM (UNII: TTV12P4NEE)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)  
    CORIANDER OIL (UNII: 7626GC95E5)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HINOKITIOL (UNII: 5MPS47D679)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83252-003-000.07 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/06/2023
    Labeler - Veganic SKN Limited (743536682)
    Establishment
    NameAddressID/FEIBusiness Operations
    Veganic SKN Limited743536682manufacture(83252-003) , pack(83252-003) , label(83252-003)