Label: ZINXATION SUNSCREEN SPF-50- zinc oxide lotion

  • 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 July 29, 2021

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  • ACTIVE INGREDIENT

    ZINC OXIDE 25%

  • PURPOSE

    SUNSCREEN

  • USES

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by the sun
  • WARNINGS

    • Avoid prolonged exposure in the sun.
    • Wear protective clothing-hats and sunglasses.
    • Do not swallow.
    • For external use only.
    • Avoid contact with eyes.
    • If a rash or irritation occurs discontinue use.
  • DIRECTIONS:

    • Apply generously to all areas 20 minutes before sun exposure.
    • Reapply every 2 hours or after swimming.
  • INACTIVE INGREDIENTS

    Coco-caprylate/caprate, glycerine, coconut alkane, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3-polyricinoleate, cera alba (beeswax), isostearic acid, polyhydroxy stearic acid, maltodextrin, phenylpropanol, propanediol, caprylyl glycol, tocopherol, ethylhexylglycerin, cetyl phosphate, sodium chloride, disodium EDTA

  • QUESTIONS OR COMMENTS?

    Call +61 73726 2030

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Astiva_ZinXation Face and Body_SPF-50_Page_1

    01b LBL_Astiva_ZinXation Face and Body_SPF-50_Page_2

  • INGREDIENTS AND APPEARANCE
    ZINXATION SUNSCREEN  SPF-50
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80982-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    JOJOBA OIL (UNII: 724GKU717M)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80982-001-38100 g in 1 TUBE; Type 0: Not a Combination Product07/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/16/2018
    Labeler - ASTIVITA LIMITED (742799513)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASTIVITA LIMITED742799513label(80982-001) , manufacture(80982-001)
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