Mineral Mist Spray
FDA Label NDC 73088-107

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tubby Todd for the product Mineral Mist (NDC 73088-107). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Otc - Keep Out Of Reach Of Children

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.

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

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