DERMA E MINERAL SUNSCREEN MINERAL- zinc oxide powder

Derma E Mineral sunscreen by

Drug Labeling and Warnings

Derma E Mineral sunscreen by is a Otc medication manufactured, distributed, or labeled by derma e, Topiderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredients

Titanium Dioxide 17.29%
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

Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Capryloyl Glycine, Chamomilla Recutita (Matricaria) Flower Extract, Mica, Potassium Sorbate, Silica, Sodium Benzoate, Tocopherol, Undecylenoyl Glycine. May contain Iron Oxides (CI 77492, CI 77489)

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 - 4 g Container Carton

100% VEGAN SOY-FREE
CRUELTY-FREE
SPF
30

DERMA E
ESSENTIALS

Sun Protection
Mineral Powder

BROAD SPECTRUM SPF 30

oil-free, mattifying with
a translucent finish
for all skin types

DERMATOLOGIST
RECOMMENDED

0.14 OZ / 4 g

INGREDIENTS AND APPEARANCE

DERMA E MINERAL SUNSCREEN   MINERAL
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54108-1485
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	172.9 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54108-1485-2	1 in 1 BOX	12/01/2021
1	NDC: 54108-1485-1	4 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2021

Labeler - derma e (148940450)

Registrant - Topiderm, Inc. (049121643)