Label: MICKEY SUN SMACKER SPF 24 HOME RUN STAR FRUIT- octinoxate, oxybenzone, padimate o lipstick

  • 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 September 6, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENTS

    Octinoxate 7.5 percent w per w

    Oxybenzone 6.0 percent w per w

    Padimate 0 8.0 percent w per w

  • PURPOSES

    Sunscreen

  • USE

    HELPS PREVENT SUNBURN.

  • WARNINGS

    Skin Cancer Skin Aging Alert. Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    For external use only

  • Do not use

    on damaged or broken skin

  • Stop use and ask a doctor

    if rash occurs

  • When using this product

    keep out of eyes. Rinse with water to remove

  • Keep out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away

  • DIRECTIONS

    • Apply liberally 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Children under 6 months of age: Ask a doctor.
  • Storage and Handling

    Protect this product from excessive heat and direct sun

  • INACTIVE INGREDIENTS

    RICINUS COMMUNIS (CASTOR) SEED OIL, CETYL ACETATE, BEESWAX (CERA ALBA), EUPHORBIA CERIFERA (CANDELILLA) WAX, FLAVOR/AROMA, POLYBUTENE, COPERNICIA CERIFERA (CARNAUBA) WAX, OZOKERITE, ACETYLATED LANOLIN ALCOHOL, SESAMUM INDICUM (SESAME) SEED OIL, ISOPROPYL MYRISTATE, BENZYL BENZOATE, PARAFFIN, POLYESTER-3, TRITICUM VULGARE (WHEAT) GERM OIL, MICA, PROPYLENE GLYCOL, STEARIC ACID, HYDROGENATED SOY GLYCERIDES, PROPYL GALLATE, CITRIC ACID, NEOTAME, CITRAL, LINALOOL, BENZYL ALCOHOL, GERANIOL, METHYL 2-OCTYNOATE, CINNAMAL, EUGENOL, FARNESOL, LIMONENE. MAY CONTAIN (PLUS OR MINUS) TITANIUM DIOXIDE (CI 77891), BLUE 1 LAKE (CI 42090), RED 28 (CI 45410), RED 6 LAKE (CI 15850), RED 22 (CI 45380), YELLOW 5 LAKE (CI 19140), CARMINE (CI 75470).

  • Questions or Comments

    Call 1-866-984-1433

  • Package Label

    SUNSCREEN LIP BALM SPF 24
    SUN SMACKER
    Home Run Star Fruit

    (c) Disney
    DIST. ASPIRE BRANDS/BONNE BELL (R)
    SANTA MONICA CA 90404 N-1703 SARPSBORG NORWAY
    Made in U.S.A.   net wt 0.14 oz 4.0 g
    mickey label 1
    mickey label 2
  • INGREDIENTS AND APPEARANCE
    MICKEY SUN SMACKER SPF 24 HOME RUN STAR FRUIT  
    octinoxate, oxybenzone, padimate o lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50051-0009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
    PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    CETYL ACETATE (UNII: 4Q43814HXS)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
    SESAME OIL (UNII: QX10HYY4QV)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    MICA (UNII: V8A1AW0880)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    NEOTAME (UNII: VJ597D52EX)  
    CITRAL (UNII: T7EU0O9VPP)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GERANIOL (UNII: L837108USY)  
    METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    EUGENOL (UNII: 3T8H1794QW)  
    FARNESOL (UNII: EB41QIU6JL)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorFRUIT (fruit) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50051-0009-44 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/06/2012
    Labeler - Bonne Bell LLC (004189809)
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