Label: GLOWELL SPF 30 TINTED MINERAL SUNSCREEN LIGHT- zinc oxide and titanium dioxide cream
GLOWELL SPF 30 TINTED MINERAL SUNSCREEN MEDIUM- zinc oxide and titanium dioxide cream
GLOWELL SPF 30 TINTED MINERAL SUNSCREEN TAN- zinc oxide and titanium dioxide cream
GLOWELL SPF 30 TINTED MINERAL SUNSCREEN DEEP- zinc oxide and titanium dioxide cream

  • NDC Code(s): 83495-101-01, 83495-102-01, 83495-103-01, 83495-104-01
  • Packager: GLOWELL, LLC.
  • 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 June 20, 2023

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Zinc Oxide 14.20%Sunscreen
    Titanium Dioxide 0.5%Sunscreen
  • 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 and ask a doctor if a rash occurs.

    • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics.
  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply:
      • After 80 minutes of swimming or sweating.
      • Immediately after towel drying.
      • at least every two hours.
    • 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 am – 2pm.
      • Wear long-sleeved shirts, pants, hats, and sunglasses.
    • Children under 6 months: Ask a doctor.
  • Inactive Ingredients

    • Deionized Water, Isododecane, C12-15 Alkyl Benzoate, Iron Oxide, Butylene Glycol, Polyglyceryl-3 Diisostearate, Mica, Cocos Nucifera (Coconut) Oil, Quaternium-90 Bentonite, VP/Eicosene Copolymer, Butyrospermum Parkii (Shea) Butter, Polyhydroxystearic Acid, Gluconolactone (and) Sodium Benzoate, Fragrance, Propylene Carbonate, Bismuth Oxychloride, Triethoxycaprylylsilane, Tocopherol, Titanium Dioxide (CI77891), Ethyl Ferulate.
  • Other Information

    • Protect this product from excessive heat and direct sun. Wash with soap to remove from skin.
  • Questions or Comments?

    Call 1-833-GLOW-SPF

  • SPL UNCLASSIFIED SECTION

    Distributed by: Glowell, LLC.
    South Plainfield, NJ 07080.

  • PRINCIPAL DISPLAY PANEL - 147 mL Tube Label - Light

    GLO
    WELL®

    SPF30

    TINTED
    MINERAL
    SUNSCREEN

    ADAPTS TO SKIN TONE
    WITH A BUILDABLE
    GLOWING FINISH

    FOR
    LIGHT SKIN
    TONES

    UVA/UVB BROAD SPECTRUM SPF 30
    WATER RESISTANT 80 MINUTES
    5FL OZ. (147mL)

    PRINCIPAL DISPLAY PANEL - 147 mL Tube Label - Light
  • PRINCIPAL DISPLAY PANEL - 147 mL Tube Label - Medium

    GLO
    WELL®

    SPF30

    TINTED
    MINERAL
    SUNSCREEN

    ADAPTS TO SKIN TONE
    WITH A BUILDABLE
    GLOWING FINISH

    FOR
    MEDIUM SKIN
    TONES

    UVA/UVB BROAD SPECTRUM SPF 30
    WATER RESISTANT 80 MINUTES
    5FL OZ. (147mL)

    PRINCIPAL DISPLAY PANEL - 147 mL Tube Label - Medium
  • PRINCIPAL DISPLAY PANEL - 147 mL Tube Label - Tan

    GLO
    WELL®

    SPF30

    TINTED
    MINERAL
    SUNSCREEN

    ADAPTS TO SKIN TONE
    WITH A BUILDABLE
    GLOWING FINISH

    FOR
    TAN SKIN
    TONES

    UVA/UVB BROAD SPECTRUM SPF 30
    WATER RESISTANT 80 MINUTES
    5FL OZ. (147mL)

    PRINCIPAL DISPLAY PANEL - 147 mL Tube Label - Tan
  • PRINCIPAL DISPLAY PANEL - 147 mL Tube Label - Deep

    GLO
    WELL®

    SPF30

    TINTED
    MINERAL
    SUNSCREEN

    ADAPTS TO SKIN TONE
    WITH A BUILDABLE
    GLOWING FINISH

    FOR
    DEEP SKIN
    TONES

    UVA/UVB BROAD SPECTRUM SPF 30
    WATER RESISTANT 80 MINUTES
    5FL OZ. (147mL)

    PRINCIPAL DISPLAY PANEL - 147 mL Tube Label - Deep
  • INGREDIENTS AND APPEARANCE
    GLOWELL SPF 30 TINTED MINERAL SUNSCREEN   LIGHT
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83495-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.142 g  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.005 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    MICA (UNII: V8A1AW0880)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83495-101-01147 mL in 1 TUBE; Type 0: Not a Combination Product07/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/05/2023
    GLOWELL SPF 30 TINTED MINERAL SUNSCREEN   MEDIUM
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83495-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.142 g  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.005 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    MICA (UNII: V8A1AW0880)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83495-102-01147 mL in 1 TUBE; Type 0: Not a Combination Product07/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/05/2023
    GLOWELL SPF 30 TINTED MINERAL SUNSCREEN   TAN
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83495-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.142 g  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.005 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    MICA (UNII: V8A1AW0880)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83495-103-01147 mL in 1 TUBE; Type 0: Not a Combination Product07/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/05/2023
    GLOWELL SPF 30 TINTED MINERAL SUNSCREEN   DEEP
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83495-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.142 g  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.005 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    MICA (UNII: V8A1AW0880)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83495-104-01147 mL in 1 TUBE; Type 0: Not a Combination Product07/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/05/2023
    Labeler - GLOWELL, LLC. (117700937)
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!