Label: HEMP LIP BALM- octisalate, oxybenzone 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 August 7, 2019

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  • ACTIVE INGREDIENTS

    OCTISALATE  7.3%

    OXYBENZONE  4.7%

  • PURPOSE

    SUNSCREEN

  • WARNINGS

    EXTERNAL USE ONLY

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • USES

    PREVENTS SUNBURN

  • DIRECTIONS

    APPLY TO AFFECTED AREA AS DESIRED.

  • INACTIVE INGREDIENTS

    Hemp flower oil, Coconut oil, Beeswax, Patrolatum, Candelilla wax, Dimethicone, Aloe oil, Flavor, Tocopherol Acetate.

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Hemp Lip Balm

  • INGREDIENTS AND APPEARANCE
    HEMP LIP BALM 
    octisalate, oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73278-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE7.3 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP (UNII: 8X454SZ22D)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73278-201-1110 mL in 1 BOTTLE; Type 0: Not a Combination Product08/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/07/2019
    Labeler - Nemadji Management LLC (100279564)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIVERSIFIED MANUFACTURING CORP185073996manufacture(73278-201)
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