Drug Facts
Active Ingredient:
Zinc Oxide 24.0%
Fre Glow Me Lightweight Tinted Moisturizer Cream
FDA Label NDC 69435-1407
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 (NDC 69435-1407). 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, purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
• If swallowed, get medical help
or contact a Poison Control Center 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.
• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
• For children under 6 months of age: 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, Coco-Caprylate, Glyceryl Oleate Citrate,
Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopherol, Argania
Spinosa Kernel Oil, Polyhydroxystearic Acid, Panthenol,
Triethoxycaprylylsilane, Lauryl Glucoside, Polyglyceryl-6 Laurate,
Propanediol, Xanthan Gum, Myristyl Glucoside, Caprylic/Capric
Triglyceride, Isomalt, Glycerin, Caprylyl Glycol, Lauroyl Lysine,
Sodium Phytate, Argania Spinosa Leaf Extract, Caprylhydroxamic
Acid, Cymbopogon Flexuosus Oil, Lavandula Angustifolia
(Lavender) Oil, Carnosine, Argania Spinosa Callus Culture Extract,
Lecithin, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron
Oxides (CI 77499).
Questions Or Comments
Call toll free 1-888-589-6243
* Please review the disclaimer below.
