MINERAL MIST SPF-50- titanium dioxide, zinc oxide spray

Mineral Mist by

Drug Labeling and Warnings

Mineral Mist by is a Otc medication manufactured, distributed, or labeled by TUBBY TODD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Titanium Dioxide 3.4%

Zinc Oxide 15.7%

PURPOSE

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.

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

Do not use on damage or broken skin.

When using this product keep out of eyes. Rinse with water to remove. keep away from face to avoid inhaling contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 ̊F.

Stop use and ask a doctor if skin rash occurs.

DIRECTIONS

Spray liberally and spread evenly by hand 15 minutes before sun exposure.
Hold 4-6 inches away from skin to apply
Reapply
-after 80 minutes of swimming or sweating
-immediately after towel drying
-at least every 2 hours
Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10am - 2pm
-wear long-sleeve shirts, pants, hats and sunglasses
Do not spray product directly on face.
Children under 6 months of age: ask a doctor.

OTHER INFORMATION

Protect this product from excessive heat and direct sun
May stain some fabrics
Do not use if quality seal is broken or missing

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Juice, Alumina, Bentonite, Beta-Sitosterol, Bisabolol, Butyloctyl Salicylate, C18-21 Alkane, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Coco-Glucoside, Dicaprylyl Carbonate, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearoyl Stearate, Isononyl Isononanoate, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyester-8, Polyhydroxystearic Acid, Propanediol, Silica, Sodium Gluconate, Sodium Stearoyl Glutamate, Squalene, Tocopherol, Water

QUESTIONS?

Call us at (619) 894-6540

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL MIST  SPF-50
titanium dioxide, zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73088-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.4 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BETA-SITOSTEROL (UNII: S347WMO6M4)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
COCO GLUCOSIDE (UNII: ICS790225B)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
BENTONITE (UNII: A3N5ZCN45C)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
C18-C21 ALKANE (UNII: 33822S0M40)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
SQUALENE (UNII: 7QWM220FJH)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73088-107-16	178 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/14/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/14/2022

Labeler - TUBBY TODD (052545299)