Otc - Active Ingredient
Active ingredient
Zinc Oxide 20.0%
Sun Veil Broad Spectrum Spf50 Lotion
FDA Label NDC 78518-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Monat Global Corp for the product Sun Veil Broad Spectrum Spf50 (NDC 78518-014). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - 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
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
Warnings
- For external use only
Otc - Do Not Use
- Do not use on damaged or broker skin.
Otc - When Using
- When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
- Stop use and ask a doctor .
- if rash occurs.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children.
- If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
Directions: Use as the last step in your MONAT skincare routine.
- Apply liberally and evenly 15 minutes before sun exposure
- Apply all over face
- Reapply at least every 2 hours
- Use a water-resistant sunscreen if swimming or sweating
- Sun Protection Measures. Spending time in the sun increases you risk od skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higheri and other sun protection measures including.
- limit time in the sun, especially form 10am-2pm
- wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredient
Inactive ingredients:
Water, Butyloctyl Salicylate, Coco-Caprylate, Sucrose Palmitate, Ethylhexyl Methoxycrylene, Niacinamide, Tocopheryl Acetate, Tocopherol, Polyhydroxystearic Acid, Glyceryl Stearate, Trihydroxystearin, Glycerin, Panthenol, Sodium Phytate, Jojoba Esters, Xanthan Gum, Glyceryl Stearate SE, Sucrose Stearate, Saccharide Isomerate, Sodium Stearoyl Glutamate, Octyldodecanol, Dehydroacetic Acid, Sodium Citrate, Citric Acid, Benzyl Alcohol, Alcohol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).
Package Label.Principal Display Panel
Primary Package (Tube Pp)
Secondary Package (Carton Sp)
* Please review the disclaimer below.
