Label: LIP SMACKER SPF 24 COOL STRAWBERRY ORANGE- octinoxate, oxybenzone lipstick

  • Category: HUMAN OTC DRUG LABEL

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 October 11, 2012

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  • ACTIVE INGREDIENTS

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

  • PURPOSE

    SUNSCREEN

  • USE

    HELPS PREVENT SUNBURN

  • WARNINGS

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

  • DIRECTIONS

    APPLY LIBERALLY BEFORE SUN EXPOSURE AND AS NEEDED.

  • ASK DOCTOR

    CHILDREN UNDER 6 MONTHS OF AGE, ASK A DOCTOR.

  • PACKAGE LABEL DISPLAY

    LiP SMACKER (R)

    Cool Strawberry Orange

    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

  • INGREDIENTS AND APPEARANCE
    LIP SMACKER SPF 24 COOL STRAWBERRY ORANGE 
    octinoxate, oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50051-0016
    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
    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    
    ShapeSize
    FlavorSTRAWBERRY (strawberry) , ORANGE (orange) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50051-0016-44 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/11/2012
    Labeler - Bonne Bell LLC (004189809)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apex International015226132manufacture(50051-0016)
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