FDA Label for Solar Protection Formula Tizo Spf 35 Sunscreen
View Indications, Usage & Precautions
Solar Protection Formula Tizo Spf 35 Sunscreen Product Label
The following document was submitted to the FDA by the labeler of this product Fallien Cosmeceuticals, Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
DRUG FACTS
Active Ingredients:
Zinc Oxide 20%
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.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - When Using
When using this product, keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
Keep out of the 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 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- Children under 6 months: Ask a doctor
- 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 10:00 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information:
- Protect this product from excessive heat and direct sun
- May stain some fabrics
Inactive Ingredients:
C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Methicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water
Manufactured exclusively for
Fallien, Ltd.
West Norriton PA 19403
Made in USA
Principal Display Panel – Spf 35 100G Carton Label
NDC 58892-318-01
SOLAR
PROTECTION
FORMULA®
TiZO®
For Ultra
Sensitive Skin
20% Zinc Oxide
Pure Mineral Protection
SPF 35
Broad Spectrum
Water Resistant
(40 minutes)
Net Wt. 3.5 Oz./ 100g
* Please review the disclaimer below.