Fre Glow Me Lightweight Tinted Moisturizer Light Medium Cream
FDA Label NDC 69435-1401

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Peer Pharm Ltd. for the product Fre Glow Me Lightweight Tinted Moisturizer Light Medium (NDC 69435-1401). 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, keep out of reach of children., directions, 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 19.2%

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
  • 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, call a Poison Control Center or get medical help right  away.

Directions

  • Shake well before use.
  • Apply liberally 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 am to 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • Children under 6 months: ask a doctor

Other Information

Protect the product in this container from excessive heat and direct sun. Do not use if the seal is broken.

Inactive Ingredients

Water (Aqua), Coco-Caprylate, Glyceryl Oleate Citrate, Stearyl Octyldodecyl Citrate Crosspolymer, Lauryl Glucoside, Xanthan Gum,Panthenol, Argania Spinosa Kernel Oil, Polyglyceryl-6 Laurate,Propanediol, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Isomalt,Caprylic/Capric Triglyceride, Glycerin, Myristyl Glucoside, Caprylyl Glycol, Sodium Phytate, Lauroyl Lysine, Argania Spinosa Leaf Extract,Caprylhydroxamic Acid, Tocopherol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Cymbopogon, Flexuosus Oil, Lavandula Angustifolia (Lavender) Oil, Carnosine, Argania Spinosa Callus Culture Extract, Lecithin, Titanium Dioxide, Iron Oxide Yellow (CI 77492), Iron Oxide Red (CI 77491), Iron Oxide Black (CI 77499).

Questions Or Comments

Call 951-297-7976 or visit www.kcare.co.il

Product Label

Image Description (Label 1401)

Image Description (Label 1401)

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