Active Ingredients
Zonc Oxide 16%
Zinc Oxide Cream
FDA Label NDC 67923-107
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vege Labs Llc for the product Zinc Oxide (NDC 67923-107). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of sun cancer and early skin aging caused by the sun.
Warnings
For external use only
Do Not Use
on damages or broken skin
When Using This Product
Keep out of eyes. Rinse with water to remove.
Stop Use And Ask A Doctor If
rash occurs
Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a poison control center right away
Directions
Apply Liberally 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. to 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses
Children under 6 months of age: Ask a doctor
Other Information
Protect this product from excessive heat or direct sun
Inactive Ingredients
Water, Isoamyl Laurate, Dimethicone, Polymethylsilsesquioxane/Silica Crosspolymer, Propanediol, Butyloctyl Salicylate, Glycerin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, PEG/PPG-18/18 Dimethicone, Cocoglycerides, Coconut Alkanes, Sodium Chloride, Polyhydroxystearic Acid, Oryza Sativa (Rice) Germ Extract, Oryza Sativa (Rice) Extract, Bisabolol, Zingiber Officinale (Ginger) Root Extract, Cistus Incanus Flower/Leaf/Stem Extract, Coco-Caprylate/Caprate, Polysilicone-11, Caprylyl Methicone, Disteardimonium Hectorite, Tocopheryl Acetate, Triethyl Citrate, Tocopherol, Stearyl Triethoxysilane, Glycine Soja (Soybean) Oil, Polyglyceryl-3 Diisostearate, Phenylpropanol, 1,2-Hexanediol, Trisodium Ethylenediamine Disuccinate, Caprylhydroxamic Acid, Sodium Citrate, Iron Oxides
* Please review the disclaimer below.
