Label: SUNSCREEN- zinc oxide lip balm stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 5, 2022

If you are a consumer or patient please visit this version.

  • Active Ingredient Section

    Active Ingredient

  • INACTIVE INGREDIENT

    Inactive Ingredients

  • Indications and Usage

    Indications and Usage

  • Keep out of reach of children

    OTC Keep Out Of Reach Of Children

  • Purpose Section

    OTC Purpose

  • Warnings Section

    Warnings

  • Label Artwork

    Artwork

  • Unit Carton Artwork

    Artwork UC

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    zinc oxide lip balm stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-267
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    .GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    .DELTA.-TOCOPHEROL (UNII: JU84X1II0N)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    JOJOBA OIL (UNII: 724GKU717M)  
    .BETA.-TOCOPHEROL (UNII: 9U6A490501)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorPINEAPPLE (Pina Colada) , COCONUT (Pina Colada) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-267-381 in 1 CARTON05/05/2022
    14.2 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/05/2022
    Labeler - Private Label Select Ltd CO (005415463)