Active Ingredients
Zinc Oxide 24%
Fre Bronze Me Sun-kissed Mineral Sunscreen Spf 50 Cream
FDA Label NDC 69435-1413
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 Bronze Me Sun-kissed Mineral Sunscreen Spf 50 (NDC 69435-1413). 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, stop use and ask a doctor, 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
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:
• After 80 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 this product in this container from
excessive heat and direct sun.
• Do not use if the seal is broken.
Inactive Ingredients
Water, Coco-Caprylate/Caprate, Dicaprylyl Ether,
Glycerin, Propanediol, Polyglyceryl-6 Stearate,
Silica, Polyhydroxystearic Acid, Vitis Vinifera (Grape)
Seed Oil, Rosa Canina Fruit Extract, Niacinamide,
Butyrospermum Parkii (Shea) Butter, Simmondsia
Chinensis (Jojoba) Seed Oil, Triethoxycaprylylsilane,
Cetyl Alcohol, Xanthan Gum, Caprylyl Glycol,
Glyceryl Stearate, Argania Spinosa Kernel (Argan)
Oil, Panthenol, Ascorbyl Tetraisopalmitate, Lecithin,
Sclerotium Gum, Pullulan, Polyglyceryl-6 Behenate,
Caprylhydroxamic Acid, Tocopherol, Pongamia
Pinnata Seed Extract, Pongamol, Argania Spinosa
Leaf Extract, Argania Spinosa Callus Culture Extract,
Isomalt, Cananga Odorata Flower (Ylang-Ylang) Oil,
Iron Oxides (CI 77492), Iron Oxides (CI 77491),
Mica, Iron Oxides (CI 77499).
Questions & Comments
Call toll free 1-888-589-6243
* Please review the disclaimer below.
