DERMA E MINERAL SUNSCREEN  MINERAL- zinc oxide powder 
derma e

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Derma E Mineral Sunscreen
Mineral

Drug Facts

Active Ingredients

Titanium Dioxide 17.29%
Zinc Oxide 20%

Purpose

Sunscreen

Uses

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

Other information

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

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

Principal Display Panel - 4 g Container Carton
DERMA E MINERAL SUNSCREEN   MINERAL
zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54108-1485
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE172.9 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54108-1485-21 in 1 BOX12/01/2021
1NDC:54108-1485-14 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/01/2021
Labeler - derma e (148940450)
Registrant - Topiderm, Inc. (049121643)

Revised: 1/2023
Document Id: 54cde561-0789-4ed3-825f-40d638a71001
Set id: e1af1f74-ee85-4375-a7aa-f5f9af5dc918
Version: 1
Effective Time: 20230130
 
derma e