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
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
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
-
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
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 147 mL Tube Label - Light
- PRINCIPAL DISPLAY PANEL - 147 mL Tube Label - Medium
- PRINCIPAL DISPLAY PANEL - 147 mL Tube Label - Tan
- PRINCIPAL DISPLAY PANEL - 147 mL Tube Label - Deep
-
INGREDIENTS AND APPEARANCE
GLOWELL SPF 30 TINTED MINERAL SUNSCREEN LIGHT
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83495-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.142 g in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.005 g in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:83495-101-01 147 mL in 1 TUBE; Type 0: Not a Combination Product 07/05/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 07/05/2023 GLOWELL SPF 30 TINTED MINERAL SUNSCREEN MEDIUM
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83495-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.142 g in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.005 g in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:83495-102-01 147 mL in 1 TUBE; Type 0: Not a Combination Product 07/05/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 07/05/2023 GLOWELL SPF 30 TINTED MINERAL SUNSCREEN TAN
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83495-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.142 g in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.005 g in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:83495-103-01 147 mL in 1 TUBE; Type 0: Not a Combination Product 07/05/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 07/05/2023 GLOWELL SPF 30 TINTED MINERAL SUNSCREEN DEEP
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83495-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.142 g in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.005 g in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:83495-104-01 147 mL in 1 TUBE; Type 0: Not a Combination Product 07/05/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 07/05/2023 Labeler - GLOWELL, LLC. (117700937)