Label: WEAR ME TINTED HYDRATING FACIAL 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 March 1, 2023

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  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    WEAR ME TINTED HYDRATING FACIAL SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83252-005
    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
    WATER (UNII: 059QF0KO0R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SODIUM HINOKITIOL (UNII: 5MPS47D679)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    JOJOBA OIL (UNII: 724GKU717M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83252-005-030.1 kg in 1 TUBE; Type 0: Not a Combination Product02/27/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/27/2023
    Labeler - Veganic SKN Limited (743536682)
    Establishment
    NameAddressID/FEIBusiness Operations
    Veganic SKN Limited743536682manufacture(83252-005) , pack(83252-005) , label(83252-005)