Label: KINESYS SPF 30 SOLID SUNSCREEN- octinoxate, octisalate, oxybenzone, and titanium dioxide stick

  • NDC Code(s): 61481-0045-1, 61481-0045-2, 61481-0045-3
  • Packager: Wilc Healthcare Inc
  • 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.

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Updated September 19, 2019

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  • Directions

    Apply liberally 20 minutes prior to exposure to sun and wind. Re-apply every two hours to maximize protection. Re-apply to lips after eating or drinking. Store product below 30°C.

  • Warning

    For external use only.

    Discontinue use if signs of irritation or rash appear. Avoid contact with eyes.

    Keep out of reach of children.

    Do not use on infants less than six months of age.

  • Active Ingredients

    Octinoxate 7.5%, Octisalate 5%, Oxybenzone 4.5%, Titanium Dioxide 1%.

  • Inactive Ingredients

    PPG-2 Myristyl Ether Propionate, Stearyl Alcohol, Pentaerythrityl Tetracaprylate/Caprate, Candelilla Wax, Synthetic Beeswax, C10-30 Cholesterol/Lanosterol Esters, Tribehenin.

  • PRINCIPAL DISPLAY PANEL - 7.3 g Tube Label

    SPF 30
    sun     protection stick

    solid sunscreen for
    LIPS, FACE AND BODY

    Protects age spots, freckles,
    wrinkles and scars

    • non-comedogenic
    • hypoallergenic
    • fragrance-free
    • UVA/UVB protection

    KINeSYS®

    7.3g (0.26 OZ)
    DIN 02237002

    EarthKind™

    PRINCIPAL DISPLAY PANEL - 7.3 g Tube Label
  • INGREDIENTS AND APPEARANCE
    KINESYS  SPF 30 SOLID SUNSCREEN
    octinoxate, octisalate, oxybenzone, and titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61481-0045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.5 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PENTAERYTHRITYL TETRACAPRYLATE/TETRACAPRATE (UNII: 832C4KF14X)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61481-0045-17.3 g in 1 TUBE; Type 0: Not a Combination Product06/20/2012
    2NDC:61481-0045-24 g in 1 TUBE; Type 0: Not a Combination Product06/20/2012
    3NDC:61481-0045-31 in 1 PACKAGE06/20/2012
    3NDC:61481-0045-17.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35206/20/2012
    Labeler - Wilc Healthcare Inc (203499140)
    Registrant - Wilc Healthcare Inc (203499140)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmaceutical Research Laboratory Inc256797309manufacture(61481-0045)
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