Derma E Sun Defense Face Lotion
FDA Label NDC 54108-0419

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 Derma E Sun Defense Face (NDC 54108-0419). 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, otc - purpose, uses, 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

Other

Drug Facts

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

Otc - Purpose

Active IngredientPurpose
Zinc Oxide 19.5% }Sunscreen
Titanium Dioxide 2.64% }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

Aloe Barbadensis Leaf Juice, Aluminum Oxide, Ascorbic Acid, Camellia Sinensis Leaf Extract

Certified Organic Ingredients

, Caprylic/Capric Triglyceride, Caprylyl Caprylate/Caprate, Cellulose Gum, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Coco-Caprylate, Coco-Glucoside, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Ethylhexylglycerin, Glycerin, Isostearic Acid, Lecithin, Microcrytalline Cellulose, Panthenol, Phenoxyethanol, Phytic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Purified Water, Sclerotium Gum, Sodium Phytate, Sorbitan Olivate, Stearic Acid, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopheryl Acetate, Xanthan Gum.

Questions Or Comments?

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

Principal Display Panel - 56 G Tube Box

SUN CARE
New
&
Improved
FORMULA

DERMA • E

Sun Defense
Clear Zinc
Oil-Free
Sunscreen

BROAD SPECTRUM
SPF 30

Mineral Clear Zinc Oxide
Vitamin C & Green Tea
100% Unscented

spf
30
FACE

• DERMATOLOGIST
RECOMMENDED •

reef
safe

2 OZ / 56 g

Principal Display Panel (56 g Tube Box)

Principal Display Panel (56 g Tube Box)

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