Solvaderm Dermaxsol Dermal Defense Moisturizer Spf-30 Cream
FDA Label NDC 84197-467
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Solvaderm Llc for the product Solvaderm Dermaxsol Dermal Defense Moisturizer Spf-30 (NDC 84197-467). 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 drug facts, active ingredients:, purpose, uses:, warnings:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients:
Octocrylene 10.0%
Zinc Oxide 7.0%
Purpose
Sunscreen
Uses:
Helps prevent sunburn.
Warnings:
For external use only.
Do Not Use
on damaged 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 to all skin exposed to the sun.
*Apply liberally and evenly 15 minutes before sun exposure.
*Reapply at least every 2 hours.
*Use a water-resistant sunscreen if swimming or sweating.
*If pregnant or breast-feeding, ask a health care professional before use.
*For children under 6 months of age: Ask a doctor.
Inactive Ingredients:
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aluminum Starch Octenyl succinate, Aqua (Deionized Water), Beeswax, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Chamomilla Matricaria Extract, Cetearyl Alcohol, Cyclopentasiloxane, Diisopropyl Adipate, Dimethicone, Dimethiconol, Ethylhexylglycerin, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Hyaluronic Acid, C13-14 Isoparaffin, Laureth-7, Parfum (Fragrance)., PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Sorbitan Stearate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E).
Other Information:
Protect the product in this container from excessive heat and direct sun.
Package Labeling:
Bottle (Bottle)
* Please review the disclaimer below.
