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

Derma E Sun Defense by

Drug Labeling and Warnings

Derma E Sun Defense 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 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

Aluminum Oxide, Ascorbic Acid, Camellia Sinensis Leaf Extract, 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, Helianthus Annuus (Sunflower) Seed Oil, Isostearic Acid, Lecithin, Microcrystalline Cellulose, Panthenol, Phenoxyethanol, Phytic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Purified Water, Sclerotium Gum, Butyrospermum Parkii (Shea) Butter, Sodium Phytate, Sorbitan Olivate, Stearic Acid, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopheryl Acetate, Xanthan Gum.

*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 Box

SUN CARE
New
&
Improved
FORMULA

DERMA E

Sun Defense
Clear Zinc
Sunscreen
BROAD SPECTRUM
SPF 30

Mineral Clear Zinc Oxide
Vitamin E & Shea Butter
100% Unscented

spf
30
BODY

DERMATOLOGIST
RECOMMENDED

reef
safe

4 OZ / 113 g

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54108-0418
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
COCO-CAPRYLATE (UNII: 4828G836N6)
COCO-GLUCOSIDE (UNII: ICS790225B)
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
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)
SHEA BUTTER (UNII: K49155WL9Y)
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)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54108-0418-1	1 in 1 BOX	12/30/2022
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	12/30/2022

Labeler - derma e (148940450)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(54108-0418)