Face Reality Power Mineral Sunscreen Spf 50 Cream
FDA Label NDC 70707-456

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 Power Mineral Sunscreen Spf 50 (NDC 70707-456). 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 19%

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

  • Protect the product from excessive heat and direct sun.

Inactive Ingredients:

Water (Aqua), Coco-Caprylate/Caprate, Dimethicone, Squalane, Glycerin, Cetearyl Alcohol, Dicaprylyl Carbonate, Isopentyldiol, Polyhydroxystearic Acid, Sorbitan Olivate, Coco-Glucoside, Pongamia Pinnata Seed Extract, Ceramide NP, Polysilicone-11, Tocopheryl Acetate, Caprylyl/Capryl Glucoside, Linoleic Acid, Polyglyceryl 10 Stearate, Phytosterols, Panthenol, Bisabolol, Allantoin, Sodium Hyaluronate, Hydrogenated Lecithin, Dipotassium Glycyrrhizate, Asiaticoside, Camellia Sinensis Leaf Extract, Madecassic Acid, Asiatic Acid, Linolenic Acid, Centella Asiatica Extract, Tocopherol, Phenoxyethanol, PEG-10 Dimethicone, Ethylhexylglycerin, Acacia Senegal Gum, Tetrasodium Glutamate Diacetate, Xanthan Gum, Sucrose Stearate, Capryloyl Glycerin/Sebacic Acid Copolymer, Bis-Dodecylhexadecyl Dimer Dilinoleate/Propanediol Copolymer, Silica, Helianthus Annuus (Sunflower) Seed Oil, Iron Oxides (CI 77492), Sodium Citrate, Iron Oxides (CI 77499), Iron Oxides (CI 77491)

Questions Or Comments?

1-866-477-3077

Package Labeling: 60Ml

Label2 (Label2)

Label2 (Label2)

Package Labeling: 118Ml

Label3 (Label3)

Label3 (Label3)

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