Tubby Todd - Mineral Mist SPF 50 (73088-107)

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]

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

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.

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Tubby Todd - Mineral Mist SPF 50 (73088-107)

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.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Do not spray product directly on face. Spray onto hands and rub onto face.

Do not inhale spray.

• Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.
  

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

DIRECTIONS

• Apply generously 15 minutes before sun exposure and as needed.
• Reapply
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Children under 6 months of age: ask a doctor

• 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 10am-2pm
• wear long-sleeved shirts, pants, hats, and sunglasses.

OTHER INFORMATION

• PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENT

ALOE BARBADENSIS LEAF JUICE, ALUMINA, BENTONITE, BISABOLOL, BUTYLOCTYL SALICYLATE, C18-21 ALKANE, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL, CELLULOSE GUM, CETEARYL ALCOHOL, CITRIC ACID, COCO-GLUCOSIDE, DICAPRYLYL CARBONATE, GLYCERIN, ISOCETYL STEAROYL STEARATE, ISONONYL ISONONANOATE, METHYL DIHYDROABIETATE, MICROCRYSTALLINE CELLULOSE, MUSA SAPIENTUM (BANANA) FRUIT EXTRACT, POLYESTER-8, POLYHYDROXYSTEARIC ACID, PROPANEDIOL, SILICA, SODIUM GLUCONATE, SODIUM STEAROYL GLUTAMATE, TOCOPHEROL, WATER

QUESTIONS?

(619) 894-6560

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
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)	Â
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)	Â
BANANA (UNII: 4AJZ4765R9)	Â
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)	Â
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	Â
SODIUM GLUCONATE (UNII: R6Q3791S76)	Â
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)	Â
TOCOPHEROL (UNII: R0ZB2556P8)	Â
WATER (UNII: 059QF0KO0R)	Â
COCO GLUCOSIDE (UNII: ICS790225B)	Â
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	Â
ALOE VERA LEAF (UNII: ZY81Z83H0X)	Â
GLYCERIN (UNII: PDC6A3C0OX)	Â
PROPANEDIOL (UNII: 5965N8W85T)	Â
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)	Â
ALUMINUM OXIDE (UNII: LMI26O6933)	Â
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)	Â
BENTONITE (UNII: A3N5ZCN45C)	Â
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)	Â
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)	Â
C18-C21 ALKANE (UNII: 33822S0M40)	Â
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)	Â
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	Â
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)	Â
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	Â
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)	Â
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)	Â

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 not final	part352	04/14/2022

Labeler - TUBBY TODD (052545299)

Revised: 4/2022

Document Id: dca549a9-0c36-2924-e053-2a95a90a98fc

34390-5

Set id: dca54a19-af25-ce47-e053-2a95a90a22db

Version: 1

Effective Time: 20220414

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