Otc - Active Ingredient
Active ingredient
Zinc Oxide 9.82%
The following Structured Product Label (SPL) was submitted to the FDA by Cosmax Usa, Corporation for the product Tinted Lip Cream Spf 15 (NDC 68577-169). 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 otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - keep out of reach of children, directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient
Zinc Oxide 9.82%
Purpose
Sunscreen
Uses
Warnings
For external use only
Do not useon damaged or broken skin
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Inactive ingredients:
Hydrogenated Polydecene, Diisostearyl Malate, Ozokerite, Synthetic Wax, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Butyloctyl Salicylate, Tridecyl Trimellitate, Bis-Diglyceryl Polyacyladipate-2, Pentaerylhrityl Tetraisostearate, Polyglyceryl-4 Isostearate, Dimer Dilinoleyl Dimer Dilinoleate, Diglyceryl Sebacate/lsopalmitate*, Moringa Oil/Hydrogenated Moringa Oil Esters, Polyhydroxystearic Acid, Silica, Caprae Lac (Goat Milk), Tocopherol (Vitamin E), Kaolin, Hydrogenated Vegetable Oil, Quercetin, Oleic/Linoleic/Linolenic Polyglycerides, Poly C10-30 Alkyl Acrylate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-2 Triisostearate, Stearalkonium Hectorite, Propylene Carbonate, Dehydroacetic Acid, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Iron Oxides (CI 77492), Titanium Dioxide (CI 77891), Carmine (CI 75470).
* Please review the disclaimer below.