FDA Label for Lipcotz Lip Balm/sunscreen

View Indications, Usage & Precautions

Lipcotz Lip Balm/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.

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Drug Facts


Active Ingredients



Titanium Dioxide 4.0%

Zinc Oxide 5.5%


Purpose



Sunscreen

Sunscreen


Uses:



Helps prevent sunburn; higher SPF gives more sunburn protection for skin that sunburns easily


Warnings:



For External Use Only. Stop use and consult a physician if rash or irritation develops. Avoid contact with eyes.


Keep Out Of Reach Of Children:



If swallowed, get medical help or contact a Poison Control Center.


Directions:



Apply generously to lips prior to sun exposure. Reapply often and after water activity, excessive perspiration or towel drying. Children under 6 years old, consult a physician.


Inactive Ingredients:



Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus Annus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxides, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxy Stearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Offinale (Ginger) Root Oil


Principal Display Panel – Carton Label



NDC 58892-125-87

SPF 45

LIPCŌTZ

Contains Only Titanium & Zinc™

SPF 45

Contains Only Titanium & Zinc™

Ultra High Sun Protection no chemical sunscreen filters

Net Wt. .14 Oz./ 4.5 g

For Information Call:

800-332-5536

Manufactured for: Fallene, Ltd

West Norriton, PA


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