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Drug Facts
Distributed by DERMA E®
Simi Valley, CA 93065, USA
Derma E Sun Defense Lotion
FDA Label NDC 54108-0418
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 (NDC 54108-0418). 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
Otc - Purpose
| Active Ingredient | Purpose |
|---|---|
| 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
Aluminum Oxide, Ascorbic Acid, Camellia Sinensis Leaf Extract, 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, Helianthus Annuus (Sunflower) Seed Oil, Isostearic Acid, Lecithin, Microcrystalline Cellulose, Panthenol, Phenoxyethanol, Phytic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Purified Water, Sclerotium Gum, Butyrospermum Parkii (Shea) Butter, Sodium Phytate, Sorbitan Olivate, Stearic Acid, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopheryl Acetate, Xanthan Gum.
*Certified Organic Ingredients
Questions Or Comments?
Call toll free 1-800-933-9344 or visit dermae.com
Principal Display Panel - 113 G Tube Box
SUN CARE
New
&
Improved
FORMULA
DERMA • E
Sun Defense
Clear Zinc
Sunscreen
BROAD SPECTRUM
SPF 30
Mineral Clear Zinc Oxide
Vitamin E & Shea Butter
100% Unscented
spf
30
BODY
DERMATOLOGIST
RECOMMENDED
reef
safe
4 OZ / 113 g
Principal Display Panel (113 g Tube Box)
* Please review the disclaimer below.
