Mineral Sunscreen Spf 50 Lotion
FDA Label NDC 73492-720

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alaina Healthcare Private Limited for the product Mineral Sunscreen Spf 50 (NDC 73492-720). 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, directions, inactive ingredients, other information, questions?, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients                                                                        Purpose

​​​​​​​​​​​​​​Zinc Oxide 20%..........................................................................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 use and ask a doctorif rash occurs. Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply generously and evenly 15 minutes before sun exposure

    • Reapply:

    • after 40 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 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 a.m. - 2 p.m.
      • Wear long-sleeved shirts, pants, hats, and sunglasses
      • Children under 6 months: Ask a doctor.

Inactive Ingredients

Asparagus Racemosus Root Extract, C12-15 Alkyl Benzoate, C13-15 Alkane, Caprylic/Capric Triglyceride, Citric Acid, Cyperus Rotundus Root Extract, Dibutyl Adipate, Disteardimonium Hectorite, Ectoin, Ethylhexylglycerin, Glycerin, HDI/Trimethylolhexyllactone Crosspolymer, Neopentyl Glycol Diheptanoate, Pentylene Glycol, Phenoxyethanol, Picrorhiza Kurroa Root Extract, Polyester-7, Polyglyceryl-2 Oleate, Polyglyceryl-2 Stearate, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-4 Oleate, Polyglyceryl-6 Oleate, Polyhydroxystearic Acid, Propanediol, Sodium Gluconate, Squalane, Tocopheryl Acetate, VP/Eicosene Copolymer, Water/Aqua/Eau.

Other Information

Protect this product from excessive heat and direct sun.

Questions?

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Principal Display Panel

Mineral Sunscreen - Carton Label

"image Description" (Mineral Sunscreen Spf 50ml Carton Label)

"image Description" (Mineral Sunscreen Spf 50ml Carton Label)

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