Scar Gel Cream
FDA Label NDC 54108-8111

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Derma E for the product Scar Gel (NDC 54108-8111). 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 ingredient, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by DERMA E®
Simi Valley, CA 93065, USA

Active Ingredient

Zinc Oxide 11.7% }

Purpose

Sunscreen

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

For external use only

Otc - Do Not Use

Do not use on damaged or broken 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

  • apply liberally 15 minutes before sun exposure
  • 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating

Other Information

  • protect this product from excessive heat and direct sun

Inactive Ingredients

Allantoin, C30-45 Alkyl Methicone, C30-45 Olefin, Caprylic/Capric Triglyceride, Caprylyl Methicone, Diethylhexyl Succinate, Dimethicone, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Glyceryl Behenate, HDI/Trimethylol Hexyllactone Crosspolymer, Isohexadecane, Isostearic Acid, Lecithin, Panthenol, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Silica.

Questions Or Comments?

Call toll free 1-800-933-9344 or visit dermae.com

Principal Display Panel - 43 G Tube Box

THERAPEUTIC

• 100% VEGAN • SOY-FREE •
SPF
35
CRUELTY-FREE

DERMA•E

Scar Cream
Sun Protectant
SPF 35

BROAD SPECTRUM
SPF 35

Reduces Scar Appearance
Primes & Nourishes
Mineral Sun Protection

Panthenol & Allantoin

1.5 OZ / 43 g

Principal Display Panel (43 g Tube Box)

Principal Display Panel (43 g Tube Box)

* Please review the disclaimer below.