Sun Defense Mineral Sunscreen SPF 30 Face

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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUN DEFENSE MINERAL SUNSCREEN SPF 30 FACE- zinc oxide stick 
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.

----------

Sun Defense Mineral Sunscreen SPF 30 Face

Drug Facts

Active Ingredient

Zinc Oxide 19%

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:
  • after 80 minutes of swimming or sweating
  • Immediately after towel drying
  • at least every 2 hours

Inactive Ingredients

Isopropyl Palmitate, Sorbitan Olivate, Copernicia Cerifera (Carnauba) Wax, Silica, Cetyl Esters, Oryza Sativa (Rice) Bran Wax, Glyceryl Behenate, Ascorbyl Palmitate (Vitamin C Ester), Helianthus Annuus (Sunflower) Seed Oil, Camellia Sinensis (Green Tea) Leaf Extract, Tocopherol (Vitamin E).

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

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

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

PRINCIPAL DISPLAY PANEL - 14 g Canister Carton

SUN CARE

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

DERMAE

Sun Defense
Mineral
Sunscreen

BROAD
SPECTRUM
SPF 30

Reef Safe
Water Resistant
(80 minutes)
Vitamin E &
Green Tea

Non-Greasy
100% Unscented

ACTIVE
STICK
30
NANO-FREE

DERMATOLOGIST TESTED

0.5 OZ / 14 g

SUN DEFENSE MINERAL SUNSCREEN SPF 30 FACE 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54108-0427
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	190 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Isopropyl Palmitate (UNII: 8CRQ2TH63M)
Sorbitan Olivate (UNII: MDL271E3GR)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ESTERS WAX (UNII: D072FFP9GU)
RICE BRAN (UNII: R60QEP13IC)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
Ascorbyl Palmitate (UNII: QN83US2B0N)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
Tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54108-0427-1	1 in 1 CARTON	01/01/2016	12/31/2019
1		14 g in 1 CANISTER; 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	12/31/2019

Labeler - DERMA E (148940450)

Revised: 12/2019

Document Id: a8cad602-e1ea-4167-ad0e-2b917d54ea5c

34390-5

Set id: f32336c6-647d-4c01-ad08-f7b614e77843

Version: 2

Effective Time: 20191218