Face Reality Mineral Matte Spf 28 Sunscreen Spf 28 Cream
FDA Label NDC 70707-454

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Face Reality, Llc for the product Face Reality Mineral Matte Spf 28 Sunscreen Spf 28 (NDC 70707-454). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Zinc Oxide 11.6%, Titanium Dioxide 0.67%

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.

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor

  • if rash occurs.

Keep Out Of Reach Of Children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • 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 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

Other Information

  • Store at room temperature of 68-77 F (22-25 C).

Inactive Ingredients:

Aqua (Water), Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Coco-Caprylate/Caprate, Polysorbate 60, Glycerin, Squalane, Glyceryl Isostearate, Dicaprylyl Ether, Isononyl Isononanoate, Magnesium Aluminum Silicate, 1,2-Hexanediol, Citric Acid, Caprylyl Glycol, Polyglyceryl-6 Polyricinoleate, Xanthan Gum, Polyhydroxystearic Acid, Leuconostoc/Radish Root Ferment Filtrate, Populus Tremuloides Bark Extract, Alumina, Gluconolactone, Potassium Sorbate, Aloe Barbadensis Leaf Juice Powder, Helianthus Annuus (Sunflower) Seed Oil, Trisodium Ethylenediamine Disuccinate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Fructooligosaccharides (D-beta), Allantoin, Simethicone, Tocopherol (D-alpha), Tropolone.

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