Label: BROAD SPECTRUM SPF 15 SUNSCREEN FRESH BERRY LIP BALM- road spectrum spf 15 sunscreen fresh berry lip balm stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 23, 2024

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  • ACTIVE INGREDIENT

    Avobenzone 2.0%

    Octinoxate 6.5%

    Octisalate 5.0%

    Octocrylene 1.5%

  • PURPOSE

    Sunscreen

  • WARNINGS

    For external use only

  • DO NOT USE

    on damaged or broken skin .

  • STOP USE

    Stop use and ask a doctor if rash occurs

  • WHEN USING

    Keep out of eyes. Rinse well with water to remove.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Sunflower Oil*, Beeswax, Olive Oil*, Flavor, Hemp Seed Oil*, Rosemary Extract, Tocopherol, Soybean Oil, Sunflower Seed Oil Glycerides, Aloe Extract, Canola Oil. * Organic

  • DOSAGE & ADMINISTRATION

    Apply liberally 15 mintues before sun exposure

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • PRINCIPAL DISPLAY PANEL

    2024-28350-00_Fresh Berry Premium SPF 15 BS LB_MU1 (002)

  • INGREDIENTS AND APPEARANCE
    BROAD SPECTRUM SPF 15 SUNSCREEN FRESH BERRY LIP BALM 
    road spectrum spf 15 sunscreen fresh berry lip balm stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0576
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.21 g  in 4.25 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.06 g  in 4.25 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.28 g  in 4.25 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.09 g  in 4.25 g
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SUNFLOWER OIL MONO/DIGLYCERIDES (UNII: HS7EB0C1ZH)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ROSEMARY (UNII: IJ67X351P9)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-0576-14.25 g in 1 TUBE; Type 0: Not a Combination Product04/23/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/23/2024
    Labeler - Raining Rose, Inc (083819404)
    Registrant - Raining Rose, Inc. (083819404)
    Establishment
    NameAddressID/FEIBusiness Operations
    Raining Rose, Inc.083819404manufacture(65692-0576)
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