Mineral Sunscreen Lotion
FDA Label NDC 73492-152

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 (NDC 73492-152). 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 drug facts, active ingredients, purpose, uses, warnings, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Zinc Oxide 15%

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 useon damaged or broken skin.

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

Stop use and ask a doctorif rash occurs.

Directions

  • Shake well.
  • Apply liberally 15 minutes before sun exposure.
  • 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 this risk, regularly use a sunscreen with a borad spectrum SPF 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

Aqua, Coco-Caprylate/Caprate, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Dibutyl Adipate, C12-15 Alkyl Benzoate, Glycerin, Polyester-7, Neopentyl Glycol Diheptanoate, Butyloctyl Salicylate, Squalane, VP/Eicosene Copolymer, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Polyglyceryl-2 Stearate, Asparagus Racemosus (Asparagus) Root Extract, Picrorhiza Kurroa (Picrorhiza) Root Extract, Cyperus Rotundas (Nut Grass) Root Extract, Sodium Chloride, Phenoxyethanol, Caprylyl Glycol, Sodium EDTA, Tocopherol, Tocotrienols, Ectoin.

Other Information

Protect this product from excessive heat and direct sun.

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