DERMA E SUN DEFENSE FACE SPF 30- zinc oxide titanium dioxide lotion

Derma E Sun Defense Face by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active Ingredient Purpose

Zinc Oxide 19.5% } Sunscreen

Titanium Dioxide 2.64% } 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

Aloe Barbadensis Leaf Juice, Aluminum Oxide, Ascorbic Acid, Camellia Sinensis Leaf Extract1, Caprylic/Capric Triglyceride, Caprylyl Caprylate/Caprate, Cellulose Gum, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Coco-Caprylate, Coco-Glucoside, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Ethylhexylglycerin, Glycerin, Isostearic Acid, Lecithin, Microcrytalline Cellulose, Panthenol, Phenoxyethanol, Phytic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Purified Water, Sclerotium Gum, Sodium Phytate, Sorbitan Olivate, Stearic Acid, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopheryl Acetate, Xanthan Gum.

1 Certified Organic Ingredients

Active Ingredient	Purpose
Zinc Oxide 19.5% }	Sunscreen
Titanium Dioxide 2.64% }	Sunscreen

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 - 56 g Tube Box

SUN CARE
New
&
Improved
FORMULA

DERMA E

Sun Defense
Clear Zinc
Oil-Free
Sunscreen

BROAD SPECTRUM
SPF 30

Mineral Clear Zinc Oxide
Vitamin C & Green Tea
100% Unscented

spf
30
FACE

DERMATOLOGIST
RECOMMENDED

reef
safe

2 OZ / 56 g

INGREDIENTS AND APPEARANCE

DERMA E SUN DEFENSE FACE SPF 30
zinc oxide titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54108-0419
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	195 mg in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	26.4 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM OXIDE (UNII: LMI26O6933)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
COCO-GLUCOSIDE (UNII: ICS790225B)
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FYTIC ACID (UNII: 7IGF0S7R8I)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
WATER (UNII: 059QF0KO0R)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
PHYTATE SODIUM (UNII: 88496G1ERL)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 54108-0419-1	1 in 1 BOX	12/15/2022
1		56 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 DRUG	M020	12/15/2022

Labeler - derma e (148940450)

Registrant - Topiderm, Inc. (049121643)

Name	Address	ID/FEI	Business Operations
Establishment
Topiderm, Inc.		049121643	MANUFACTURE(54108-0419)