Solvaderm - Dermaxsol
FDA Label NDC 66163-6402

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Solutions Llc for the product Solvaderm - Dermaxsol (NDC 66163-6402). 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, otc - 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.

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DRUG FACTS:

Distributed By:
Solvaderm Skincare
Spring Valley, NY 10977

Active Ingredients

Octyl Methoxycinnamate 7.5%, 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.

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

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. *For children under 6 months of age: Ask a doctor. 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. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

Water (Aqua), Stearyl Alcohol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Glyceryl Dilaurate, Cetearyl Alcohol, Beeswax, Dimethicone, Cyclomethicone , Diisopropyl Adipate, Hexylene Glycol, PEG-40 Stearate, C12-15 Alkyl Benzoate, Aluminum Starch Octenylsuccinate, PEG-20, Carnauba Wax, Dimethicone Copolyol, VP/Eicosene Copolymer, Sorbitan Tristearate, Stearoxytrimethylsilane, Steareth-100, Laureth-7, C13-14 Isoparaffin, Phenoxyethanol, Ethyhexylglycerin, Polyacrylamide.

Other Information

Protect the product in this container from excessive heat and direct sun.

Principal Display Panel - 50 G Bottle Label

SOLVADERM™
REDEFINING SKIN SCIENCE

DERMAXSOL
Dermal defense moisturizer
SPF 30 - Sunscreen Broad Spectrum

Net Wt.
1.75oz (50g)

Principal Display Panel (50 g Bottle Label)

Principal Display Panel (50 g Bottle Label)

* Please review the disclaimer below.