SUN DEFENSE MINERAL OIL-FREE SUNSCREEN SPF 30 BABY- zinc oxide cream

Sun Defense Mineral Oil-Free Sunscreen SPF 30 Baby by

Drug Labeling and Warnings

Sun Defense Mineral Oil-Free Sunscreen SPF 30 Baby by is a Otc medication manufactured, distributed, or labeled by derma e, Topiderm, Inc., Topiderm Inc. II. 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, Chamomilla Recutita (Matricaria) Flower Extract, Calendula Officinalis Flower Extract, 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

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

SUN CARE

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

DERMAE

baby

Sun Defense
Mineral Oil-Free
Sunscreen

BROAD SPECTRUM SPF 30

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

BABY
30
NANO-FREE

Reef
Safe

DERMATOLOGIST TESTED

4 OZ / 113 g

Principal Display Panel - 113 g Tube Carton

INGREDIENTS AND APPEARANCE

SUN DEFENSE MINERAL OIL-FREE SUNSCREEN SPF 30 BABY
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54108-0423
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)
Matricaria Chamomilla (UNII: G0R4UBI2ZZ)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 54108-0423-1	1 in 1 CARTON	01/01/2016
1		113 g in 1 TUBE; Type 0: Not a Combination Product

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

Labeler - DERMA E (148940450)