Drug Facts

Active ingredients	Purpose
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

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

GLOWELL SPF 30 TINTED MINERAL SUNSCREEN LIGHT
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83495-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83495-101-01	147 mL in 1 TUBE; Type 0: Not a Combination Product	07/05/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/05/2023

GLOWELL SPF 30 TINTED MINERAL SUNSCREEN MEDIUM
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83495-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83495-102-01	147 mL in 1 TUBE; Type 0: Not a Combination Product	07/05/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/05/2023

GLOWELL SPF 30 TINTED MINERAL SUNSCREEN TAN
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83495-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83495-103-01	147 mL in 1 TUBE; Type 0: Not a Combination Product	07/05/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/05/2023

GLOWELL SPF 30 TINTED MINERAL SUNSCREEN DEEP
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83495-104
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83495-104-01	147 mL in 1 TUBE; Type 0: Not a Combination Product	07/05/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/05/2023

Labeler - GLOWELL, LLC. (117700937)

Glowell® SPF 30 Tinted Mineral Sunscreen

Uses

Warnings

Directions

Inactive Ingredients

Other Information

Questions or Comments?

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