FDA Label for Cotz Spf 58 Sunscreen
View Indications, Usage & Precautions
Cotz Spf 58 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
Other Information Sun Alert: limiting sun expusure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. May stain some fabric.
Active Ingredients
Titanium Dioxide 10%
Zinc Oxide 3%
Purpose
Sunscreen
Sunscreen
Indications & Usage
Uses: Helps prevent sunburn
- Retains SPF up to 40 minutes of water immersion or perspiring
Warnings
Warnings: For external use only
- Avoid contact with eyes. In case of eye contact, flush eyes with water thoroughly
- Do not use if sensitive to ingredients • Discontinue use if irritation occurs. Consult a doctor or healthcare professional if irritation persists
- For use on children less than 6 months of age, consult a doctor.
- Keep this and all medicines out of reach of children
- If swallowed, get medical help or contact a Poison Control Center
Dosage & Administration
Directions: Apply generously and uniformly to all exposed skin areas before exposure to sunlight
- Continure to rub in until fading occurs, especially in hair bearing areas
- Reapply as needed and after washing, swimming, towel drying, or sweating for maximum protection.
Inactive Ingredients
Acrylates C10-30 Alkyl
Acrylates Crosspolymer,
Butylene Glycol, Butyloctyl
Salicylate, Butylparaben,
Capric/Caprylic Triglyceride,
Cetearyl Alcohol, Cetearyl
Glucoside, Cyclomethicone,
Dimethicone, EDTA,
Ethylhexyl Hydroxystearate
Benzoate, Glyceryl Stearate,
Iron Oxides, Isobutylparaben,
Isopropylparaben,
Melissa Officinalis (Balm
Mint) Extract, Octyldodecyl
Neopentanoate, PEG-100
Stearate, Phenoxyethanol,
Retinyl Palmitate,
Simethicone, Sorbitan
Laurate, Styrene/Acrylates
Copolymer, Talc, Tocopherol,
Tocopheryl Acetate,
Tricontanyl PVP, Water,
Xanthan Gum
Uva - Same Everyday
UVA radiation, unlike UVB, is consistently the same all day long, all month long and all year long. UVA rays present almost the same damaging effects to the skin in December at 9 am, as they do in July at 4 pm. UVA radiation is consistently damaging, and in fact, enters deeper into the skin than UVB. Since UVA damage is cumulative and penetrates through glass, everyone requires daily, year round protection.
- Extra gentle - no chemical sunscreen filters
- Dries clear
- Oil & PABA free
- Fragrance free
Manufactured exclusively for:
Fallien, West Norriton, PA 19403
www.totalblock.com
Made in USA
Principal Display Panel
Principal Display Panel – Carton Label
NDC 58892-910-87
Dermatologist Recommended for Sensitive Skin
FALLENE CoTZ®
Contains Only Titanium & Zinc®
WATER-RESISTANT SUN PROTECTION
UVA-UVB SPF 58
Net Wt. 2.5 Oz./ 70 g
* Please review the disclaimer below.
