Label: GLONATURALS - BROAD-SPECTRUM SUNSCREEN SPF 30- octinoxate and zinc oxide cream

  • 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 September 27, 2019

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENTS

    Octyl Methoxycinnamate 7.5%, Zinc Oxide 7.0%.

  • PURPOSE

    Sunscreen

  • USES

    Helps prevent sunburn.

  • 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 doctor if rash occurs.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For children under 6 months of age: Ask a doctor.

    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.
  • INACTIVE INGREDIENTS

    Water (Aqua), Stearyl Alcohol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Glyceryl Dilaurate, Cetearyl Alcohol, Beeswax, Dimethicone, Cyclomethicone , Diisopropyl Adipate, Hexylene Glycol, PEG-40 Stearate, C12-15 Alkyl Benzoate, Aluminum Starch Octenylsuccinate, PEG-20, Carnauba Wax, Dimethicone Copolyol, VP/Eicosene Copolymer, Sorbitan Tristearate, Stearoxytrimethylsilane, Steareth-100, Laureth-7, C13-14 Isoparaffin, Phenoxyethanol, Ethyhexylglycerin, Polyacrylamide.

  • OTHER INFORMATION

    Protect the product in this container from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL - 120 ML Tube Label

    glōnaturals™
    essentials
    COLLECTION

    Broad-Spectrum
    Sunscreen
    SPF 30

    4 FL OZ (120 ML)

    CSI7020102

    PRINCIPAL DISPLAY PANEL - 120 ML Tube Label
  • INGREDIENTS AND APPEARANCE
    GLONATURALS - BROAD-SPECTRUM SUNSCREEN SPF 30 
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-6403
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide70 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Glyceryl Dilaurate (UNII: MFL3ZIE8SK)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Cyclomethicone (UNII: NMQ347994Z)  
    Diisopropyl Adipate (UNII: P7E6YFV72X)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    PEG-40 Stearate (UNII: ECU18C66Q7)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
    Polyethylene Glycol 1000 (UNII: U076Q6Q621)  
    Carnauba Wax (UNII: R12CBM0EIZ)  
    PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)  
    Sorbitan Tristearate (UNII: 6LUM696811)  
    Stearoxytrimethylsilane (UNII: 9862TW94B2)  
    Steareth-100 (UNII: 4OH5W9UM87)  
    Laureth-7 (UNII: Z95S6G8201)  
    C13-14 Isoparaffin (UNII: E4F12ROE70)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66163-6403-1120 g in 1 TUBE; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35201/01/2019
    Labeler - Cosmetic Solutions LLC (807907928)
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