SUN DEFENSE MINERAL SUNSCREEN SPF 30 FACE- zinc oxide cream

Sun Defense Mineral Sunscreen SPF 30 Face by

Drug Labeling and Warnings

Sun Defense Mineral Sunscreen SPF 30 Face by is a Otc medication manufactured, distributed, or labeled by derma e, Topiderm, Inc., Topix Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

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

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 Extract1, Panthenol (Provitamin B5), Sodium Ascorbyl Phosphate (Vitamin C),Tocopheryl Acetate (Vitamin E), Phytic Acid, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Xanthan Gum, Benzyl Alcohol, Ethylhexylglycerin, Tocopherol.

1 Certified Organic Ingredients

Questions or comments?

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 56 g Tube Carton

SUN CARE

100% VEGAN GMO-FREE
ECO-ETHICAL
CRUELTY-FREE

DERMAE

Sun Defense
Mineral
Oil-Free
Sunscreen

BROAD SPECTRUM SPF 30

Non-Nano Mineral Zinc Oxide
Vitamin E & Green Tea
100% Unscented

FACE
30
OIL-FREE

Reef
Safe

DERMATOLOGIST TESTED

2 OZ / 56 g

INGREDIENTS AND APPEARANCE

SUN DEFENSE MINERAL SUNSCREEN SPF 30 FACE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54108-0420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Coco-Caprylate (UNII: 4828G836N6)
Dicaprylyl Carbonate (UNII: 609A3V1SUA)
Lauryl Glucoside (UNII: 76LN7P7UCU)
Polyglyceryl-2 Dipolyhydroxystearate (UNII: 9229XJ4V12)
Glycerin (UNII: PDC6A3C0OX)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Carboxymethylcellulose Sodium (0.7 Carboxymethyl Substitution Per Saccharide; 1200 Mpa.S At 1%) (UNII: 4J4P6L645M)
Panthenol (UNII: WV9CM0O67Z)
Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)
.Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8)
Fytic Acid (UNII: 7IGF0S7R8I)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Polyhydroxystearic acid (2300 MW) (UNII: YXH47AOU0F)
Xanthan Gum (UNII: TTV12P4NEE)
Benzyl Alcohol (UNII: LKG8494WBH)
Ethylhexylglycerin (UNII: 147D247K3P)
Tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54108-0420-1	1 in 1 CARTON	01/01/2016
1		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2016

Labeler - DERMA E (148940450)