Label: THE GREEN BEAVER COMPANY SPF 40 KIDS SUNSCREEN- sunscreen lotion lotion

  • 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 January 11, 2021

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  • ACTIVE INGREDIENT

    active ingredient

  • PURPOSE

    Purpose

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach

  • INDICATIONS & USAGE

    Uses

  • DOSAGE & ADMINISTRATION

    Directions

  • WARNINGS

    Warnings

  • INACTIVE INGREDIENT

    Inactive ingredients

  • PRINCIPAL DISPLAY PANEL

    Kids Sunscreen

  • INGREDIENTS AND APPEARANCE
    THE GREEN BEAVER COMPANY SPF 40 KIDS SUNSCREEN 
    sunscreen lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76098-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CEROTIC ACID (UNII: D42CQN6P36)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    SQUALENE (UNII: 7QWM220FJH)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    SODIUM BETA-SITOSTERYL SULFATE (UNII: I289C8TPSV)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    WATER (UNII: 059QF0KO0R)  
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    RUBUS IDAEUS FRUIT VOLATILE OIL (UNII: 276X2YNL0K)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76098-002-0194 g in 1 TUBE; Type 0: Not a Combination Product01/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/26/2018
    Labeler - The Green Beaver Company (243807018)
    Registrant - Regulatory Matters Consulting (080711165)
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