Label: GLO SKIN BEAUTY TINTED PRIMER SPF 30 cream

  • 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 21, 2017

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  • Active Ingredients

    Titanium Dioxide 4.5%

    Zinc Oxide 4%

  • Uses

    • helps prevent sunburn • if used as directed with other
    sun protection measures (see Directions), decreases the
    risk of skin cancer and early skin aging caused by the sun

  • Warnings

    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
    • Sun Protection Measures. Spending time in the sun
    increases your risk of skin cancer and early skin aging. To decrease
    this risk, regularly use a sunscreen with a Broad Spectrum SPF
    value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months of age: Ask a doctor

  • Inactive ingredients

    Isododecane, Cyclopentasiloxane, Cylcohexasiloxane, Polysilicone-11, Mica, Polymethylsilsesquioxane, Hexyl Laurate, Polyglyceryl-3 Diisostearate, PEG/PPG-20/15 Dimethicone, Triethoxycaprylylsilane, Dimethicone, Iron Oxides

  • Other Information

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

  • Principal Display Panel

    60541-1400-3

  • INGREDIENTS AND APPEARANCE
    GLO SKIN BEAUTY TINTED PRIMER SPF 30 
    glo skin beauty tinted primer spf 30 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60541-1400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.5 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISODODECANE (UNII: A8289P68Y2)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60541-1400-31 in 1 CARTON12/31/2017
    130 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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