DERMA E VITAMIN C WEIGHTLESS MOISTURIZER SPF 45- zinc oxide lotion

Derma E Vitamin C Weightless Moisturizer by

Drug Labeling and Warnings

Derma E Vitamin C Weightless Moisturizer by is a Otc medication manufactured, distributed, or labeled by derma e, Topiderm, Inc., Topiderm, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredient

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

• shake well
• 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

Apium Gravelones (Celery) Seed Extract, Aspalathus Linearis (Rooibos) Leaf Extract, Caprylic/Capric Triglyceride, Cocoglycerides, Diethylhexyl Succinate, Ethylhexylglycerin, Ethylhexyl Olivate, Glycerin, Isostearic Acid, Jojoba Esters, Lauryl Glucoside, Lecithin, Linum Usitatissimum (Linseed) Seed Extract, Natural Fragrance Oil, Niacinamide, Panthenol, Phenoxyethanol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Purified Water, Sodium Ascorbyl Phosphate, Sodium Carboxymethyl Starch, Sodium Phytate, Sorbitan Trioleate, Tetrahexyldecyl Ascorbate, Titanium Dioxide, Tocopheryl Acetate Vitamin E), 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 - 60 mL Bottle Box

VITAMIN C

100% VEGAN SOY-FREE
SPF 45
CRUELTY-FREE

DERMAE

Vitamin C
Weightless
Moisturizer

BROAD SPECTRUM
SPF 45

Rooibos
Vitamins B3 & E

prime and brighten

DERMATOLOGIST
RECOMMENDED

2 FL OZ / 60 mL

INGREDIENTS AND APPEARANCE

DERMA E VITAMIN C WEIGHTLESS MOISTURIZER   SPF 45
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54108-0359
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL OLIVATE (UNII: HTC7G3S2PV)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PHYTATE SODIUM (UNII: 88496G1ERL)
NIACINAMIDE (UNII: 25X51I8RD4)
PANTHENOL (UNII: WV9CM0O67Z)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FRAGRANCE 13576 (UNII: 5EM498GW35)
XANTHAN GUM (UNII: TTV12P4NEE)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
CELERY SEED (UNII: 1G1EAA320L)
FLAX SEED (UNII: 4110YT348C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54108-0359-1	1 in 1 BOX	05/22/2024
1		60 mL in 1 BOTTLE; 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	05/22/2024

Labeler - derma e (148940450)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc		049121643	MANUFACTURE(54108-0359)