Lipcotz
FDA Label NDC 58892-125

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fallien Cosmeceuticals, Ltd. for the product Lipcotz (NDC 58892-125). 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 other, active ingredients, purpose, uses:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredients

→ Purpose

→ Uses:

→ Warnings:

→ Keep Out Of Reach Of Children:

→ Directions:

→ Inactive Ingredients:

→ Principal Display Panel – Carton Label

Other

Drug Facts

Active Ingredients

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Purpose

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