Sun Defense Mineral Sunscreen Spf 30 Face Cream
FDA Label NDC 54108-0420

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 Sun Defense Mineral Sunscreen Spf 30 Face (NDC 54108-0420). 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

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 56 G Tube Carton

Other

Drug Facts

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

Active Ingredient

Zinc Oxide 20%

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

Purified Water, Coco-Caprylate (Coconut Derived), Dicaprylyl Carbonate, Lauryl Glucoside (Plant Derived), Polyglyceryl-2 Dipolyhydroxystearate, Glycerin (Vegetable Derived), Microcrystalline Cellulose (Plant Derived), Cellulose Gum (Plant Derived), Organic Camellia Sinensis (Green Tea) Leaf Extract

Certified Organic Ingredients

, Panthenol (Provitamin B5), Sodium Ascorbyl Phosphate (Vitamin C),Tocopheryl Acetate (Vitamin E), Phytic Acid, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Xanthan Gum, Benzyl Alcohol, Ethylhexylglycerin, Tocopherol.