Label: GLO SKIN BEAUTY BALM MINT SPF 15 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 December 27, 2017

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  • Active Ingredients

    Octinoxate 7.5%
    Oxybenzone 3%

  • Uses

    • helps prevent sunburn 

  • Warnings

    Skin Cancer/Skin Agining Alert: Spending time in the sun increases your skin cancer and early skin aging. This product has been shown only to prevent sunberun, not skin cancer or early skin aging.

    For external use only
    Do not use on damaged or broken skin
    When using this product keep out of eyes. Rinse with water to remove.
    Stop use and ask a docor if rash occurs
    Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply generously 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water-resistant sunscreen if swimming or sweating
    • children under 6 months of age: Ask a doctor

  • Inactive ingredients

    Helianthus Annuus (Sunflower) Seed Oil, Glycine Soja (Soybean) Oil, Beeswax, Euphorbia Cerifera (Candalila) Wax, Cannabis Sativa Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Aloe Barbaensis Leaf Extract, Tocopherol

  • Other Information

    • protect the product in this container from excessive
    heat and direct sun

  • Principal Display Panel

    60541-1500-1

  • INGREDIENTS AND APPEARANCE
    GLO SKIN BEAUTY BALM MINT SPF 15 
    glo skin beauty balm mint spf 15 stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60541-1500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    LIMNANTHES ALBA WHOLE (UNII: DKY81513ER)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60541-1500-11 in 1 CARTON12/31/2017
    118 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/31/2017
    Labeler - Hayden Caleel LLC (011367468)
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