Label: SPF-40 FACIAL MOISTURIZER- zinc oxide and titanium dioxide 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 April 5, 2013

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • PURPOSE

    Provides broad-spectrum protection from the sun's damaging rays while moisturizers and peptides lend anti-aging benefits.

  • RECOMMENDED FOR

    All skin types.

  • DIRECTIONS

    Apply a liberal amount daily before sun exposure. Initial whiteness turns clear after application. Reapply every 2-3 hours to maintain protection.

  • USES

    Helps prevent sunburn.

  • ACTIVE INGREDIENTS

    7.5% Titanium Dioxide, 5.0% Zinc Oxide

  • INACTIVE INGREDIENTS

    Water (Aqua), Aloe Barbadensis Leaf Juice, Capric Caprylic Triglycerides, Ethylhexyl Palmitate, Glyceryl Stearate, Cetyl Dimethicone, Glycerin, Hexyl Laurate, Pollyglyceryl-4 Isostearate, Cetyl Alcohol, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea Butter), Panthenol, Magnesium Aspartate, Zinc Gluconate, Copper Gluconate (Copper Peptides), Pamitoyl Pentapeptide-4, Malachite Extract, Smithsonite Extract, Rhodochrosite Extract, Hematite Extract, Tocopherol Acetate, Allantoin, Sodium PCA, Soy Lecithin, Magnesium Aluminum Silicate, Camellia Sinensis (Green Tea) Extract, Sodium Hyaluronate, Calendula Officinalis Flower Extract, Ethylhexylglycerin, Phenoxyethanol

  • WARNING

    For external use only.

    Do not use in or near the eyes. If contact occurs, rinse thoroughly with water.

    Mild skin irritation may occur. Stop use and ask a physician if irritation is severe.

    Do not use on infants under 6 months old.

    Keep out of reach of children. If swallowed, immediately get medical help or contact a Poison Control Center.

  • SUNBURN ALERT

    Limiting sun exposure, wearing protective clothing, and using a sunscreen agent may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    glōProfessional
    Denver, CO 80223

  • PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

    SUNSCREEN

    glō•therapeutics

    SPF 40 Facial
    Moisturizer

    7.5% Titanium Dioxide,
    5% Zinc Oxide,
    Peptides

    FACIAL SUNSCREEN

    Principal Display Panel - 60 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    SPF-40 FACIAL MOISTURIZER 
    zinc oxide and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55789-0101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide5 g  in 100 mL
    Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide7.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ethylhexyl palmitate (UNII: 2865993309)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    cetyl dimethicone 25 (UNII: U4AS1BW4ZB)  
    glycerin (UNII: PDC6A3C0OX)  
    hexyl laurate (UNII: 4CG9F9W01Q)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    polyglyceryl-4 isostearate (UNII: 820DPX33S7)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    cetyl alcohol (UNII: 936JST6JCN)  
    shea butter (UNII: K49155WL9Y)  
    panthenol (UNII: WV9CM0O67Z)  
    magnesium aspartate (UNII: R17X820ROL)  
    zinc gluconate (UNII: U6WSN5SQ1Z)  
    jojoba oil (UNII: 724GKU717M)  
    tocopherol (UNII: R0ZB2556P8)  
    copper gluconate (UNII: RV823G6G67)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    palmitoyl pentapeptide-4 (UNII: KK181SM5JG)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    allantoin (UNII: 344S277G0Z)  
    sodium pyrrolidone carboxylate (UNII: 469OTG57A2)  
    lecithin, soybean (UNII: 1DI56QDM62)  
    magnesium aluminum silicate (UNII: 6M3P64V0NC)  
    green tea leaf (UNII: W2ZU1RY8B0)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55789-0101-160 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/10/2012
    Labeler - Mineral Fusion brands (831770032)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!