Purpose
Sunscreen
Freaks Of Nature Mineral Sunscreen Aerosol, Spray
FDA Label NDC 50021-500
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Empack Spraytech Inc. for the product Freaks Of Nature Mineral Sunscreen (NDC 50021-500). 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 purpose, use, warnings, keep out of reach of children, directions, active ingredients, inactive ingredients, questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
Helps prevent sunburn
Warnings
For external use only.
Do not use on broken skin.
Do not place in hot water or near radiator, stove or other sources of heat.
Do not puncture or incinerate container or store at temperature above 50°C.
Contents under pressure.
Stop use and ask a doctor if rash occurs.
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, call a poison control center or get medical help right away.
Directions
Adults, adolescents and children over 6 months of age.
Spray generously and spread evenly by hand 15 minutes before sun exposure.
Hold container 4 to 6 inches from skin to apply.
Do not spray directly onto face. Spray on hands, then apply to face.
Do not apply in windy conditions.
Use in a well-ventilated area.
Avoid inhaling or exposing others to spray.
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 a.m. - 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses.
Test on small area of skin before first use. If irritation occurs (within 24 hours), use different product.
For use on children less than 6 months of age, ask a doctor.
Active Ingredients
Zinc Oxide - 16.5%
Inactive Ingredients
Aloe Barbendensis Leaf Juice, Aqua, Bambusa Arundinacea Stem Extract, Camellia Sinensis Leaf Extract, Capric / Caprylic Triglyceride, Dilauryl Citrate, Ethylhexylglycerin, Gluconolactone, Glycerin, Hydrogenated Methyl Abietate, Isopropyl Palmitate, Lauryl Glucoside, Leuconostoc/Radish Root Ferment Filtrate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Methylcellulose, Octyldodecyl Citrate Crosspolymer, Phenoxyethanol, Polyglyceryl-4 Laurate, Populus Tremuloides Bark Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium lauryl Glucose Carboxylate, Sodium Phytate, Sodium Stearoyl Glutamate, Sorbitan Laurate, Tocopheryl Acetate, Xanthan Gum.
Questions
Call 1-866-923-2665
Other Information
Protect the product from excessive heat and direct sun.
Store at room temperature 15–30°C (59–86°F).
May stain certain surfaces and fabrics.
* Please review the disclaimer below.
