Active Ingredients
Zinc Oxide 24.0%
Fre Glow Me Spf 50 Lightweight Tinted Moisturizer Medium Deep Cream
FDA Label NDC 69435-1408
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 Spf 50 Lightweight Tinted Moisturizer Medium Deep (NDC 69435-1408). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children, 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.
Keep Out Of Reach Of Children
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 And Comments
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