Premier Tinted Mineral Sunscreen Cream
FDA Label NDC 81341-0652

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Premier Plastic Surgery for the product Premier Tinted Mineral Sunscreen (NDC 81341-0652). 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 other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Zinc Oxide 7.5%

Titanium Dioxide 3.2%

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

Otc - Do Not Use

Do not useon damaged or broken skin

Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctorif rash occurs

Otc - Keep Out Of Reach Of Children

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

Directions

  • 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 broad spectrum SPF 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. - 2 p.m.
      • wear long-sleeve shirts, pants, hats and sunglasses
      • children under 6 months: Ask a doctor

Inactive Ingredients

Water, Caprylic Capric Triglyceride, Cyclopentasiloxane, C30-45 Alkylcetearyl, Dimethicone Crosspolymer, C13-15 Alkane, Stearic Acid, Aluminum Hydroxide, Polyhydroxystearic Acid, Octyldodecyl Neopentanoate, Glycerin, Buddleja Davidii (Summer Lilac) Extract, Thymus Vulgaris (Thyme) Extract, Sodium Chloride, Sorbitan Oleate,Tetrasodium Edta, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Perflourodecalin, Mica, Titanium Dioxide (CI77891), Iron Oxides (CI77491).

Other Information

  • protect this product from excessive heat and direct sun

* Please review the disclaimer below.