Label: LIP SMACKER SPF CHERRY BERRY BALL - octinoxate, oxybenzone and padimate o lipstick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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  • ACTIVE INGREDIENTS

    OCTINOXATE 7.5% W/W, OXYBENZONE 6.0% W/W, PADIMATE O 8.0% W/W.

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  • PURPOSE

    SUNSCREEN

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  • USE

    HELPS PREVENT SUNBURN

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  • WARNINGS

    STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS.

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  • DIRECTIONS

    APPLY LIBERALLY BEFORE SUN EXPOSURE AND AS NEEDED.

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  • ASK DOCTOR

    CHILDREN UNDER 6 MONTHS OF AGE, ASK A DOCTOR.

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  • PACKAGE LABEL DISPLAY

    LiP SMACKER (R)

    Cherry Berry Ball

    DIST. ASPIRE BRANDS/BONNE BELL (R)
    SANTA MONICA CA 90404
    Made in U.S.A. net wt. 0.14 oz/4.0 g

    SPF 24

    lip smacker label

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  • INGREDIENTS AND APPEARANCE
    LIP SMACKER SPF CHERRY BERRY BALL  
    octinoxate, oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50051-0018
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g  in 100 g
    PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O 8 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    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)  
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (Cherry Berry Ball) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50051-0018-4 4 g in 1 CYLINDER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 10/11/2012
    Labeler - Bonne Bell LLC (004189809)
    Establishment
    Name Address ID/FEI Business Operations
    Apex International 015226132 manufacture(50051-0018)
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