FDA Label for Cotz Spf 35 Sunscreen
View Indications, Usage & Precautions
Cotz 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.
Active Ingredients:
Zinc Oxide 20%.
Purpose
Sunscreen
Uses
- Helps prevent sunburn
- Provides protection from UVA & UVB rays that may contribute to premature aging of the skin
- Retains SPF up to 40 minutes of water immersion or perspiring
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 medications out of the reach of children
- If swallowed, get medical help or contact a Poison Control Center
Directions
- Apply generously and uniformly to all exposed skin areas before exposure to sunlight
- Continue 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.
- Sun Alert: Limiting sun exposure, 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 fabrics
Other Information
Inactive Ingredients:
C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/VinyI Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane,
Manufactured
exclusively for
Fallene, Ltd.
West Norriton, PA 19403
Made in USA
Principal Display Panel – 3.5Oz Carton Label
NDC 58892-118-01
Dermatologist
Recommended for
Ultra Sensitive Skin
CoTZ®
20% Zinc Oxide
vanishing formula
Pure Mineral
Sun protection
Moisturizing
water resistant
uva/uvb
SPF 35
Net. Wt. 3.5 oz./ 100g
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