Label: ZINKA CLEAR ZINC OXIDE SUNSCREEN- octinoxate, zinc oxide, octisalate, oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 April 4, 2022

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  • Active Ingredients

    Octinoxate 5.0% w/w

    Zinc Oxide 4.3% w/w

    Octisalate 3.0% w/w

    Oxybenzone 2.5% w/w

  • Purposes

    Sunscreen

  • ​Uses

    • Helps prevent sunburn and skin damage caused by UVA/UVB exposure
    • Higher SPF gives more sunburn protection
  • ​Warnings

    For external use only

  • ​When using this product

    • Keep out of eyes.  Rinse with water to remove
    • Do not use if allergic to any ingredient
    • Keep out of reach of children
    • If swallowed, contact Poison Control Center immediately
  • ​Stop use and ask doctor if

    • Rash or irritation develops and lasts
  • ​Directions

    • Apply liberally 20 minutes before sun exposure to dry skin
    • Reapply to dry skin after toweling, swimming or sweating
    • For children under 6 months of age: Ask a doctor
  • ​Other information

    Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

  • ​Inactive Ingredients

    Water, Isopropyl Myristate, Aloe Barbadensis Leaf Extract, Diisostearoyl Polyglyceryl-3 Diisostearate, Hydrogenated Polyisobutene, Cetyl Dimethicone, Octyl Palmitate, Retinyl Palmitate, Tocopheryl Acetate, Magnesium Sulfate, Propylene Glycol, White Bees Wax, Hydrogenated Castor Oil, Caprylyl Glycol, Disodium EDTA, Methylisothiazolinone

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ZINKA CLEAR ZINC OXIDE SUNSCREEN 
    octinoxate, zinc oxide, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52993-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE43 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    HYDROGENATED POLYBUTENE (370 MW) (UNII: V5H8103878)  
    DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52993-001-0385.1 g in 1 TUBE; Type 0: Not a Combination Product09/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/01/2007
    Labeler - Zinka, Inc. (153569595)
    Establishment
    NameAddressID/FEIBusiness Operations
    A.I.G. Technologies, Inc.086365223manufacture(52993-001) , label(52993-001)
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