SCAR GEL SPF 35- zinc oxide cream

Scar Gel by

Drug Labeling and Warnings

Scar Gel 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

Zinc Oxide 11.7% }

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 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

Allantoin, C30-45 Alkyl Methicone, C30-45 Olefin, Caprylic/Capric Triglyceride, Caprylyl Methicone, Diethylhexyl Succinate, Dimethicone, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Glyceryl Behenate, HDI/Trimethylol Hexyllactone Crosspolymer, Isohexadecane, Isostearic Acid, Lecithin, Panthenol, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Silica.

Questions or comments?

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 43 g Tube Box

THERAPEUTIC

100% VEGAN SOY-FREE
SPF
35
CRUELTY-FREE

DERMAE

Scar Cream
Sun Protectant
SPF 35

BROAD SPECTRUM
SPF 35

Reduces Scar Appearance
Primes & Nourishes
Mineral Sun Protection

Panthenol & Allantoin

1.5 OZ / 43 g

INGREDIENTS AND APPEARANCE

SCAR GEL  SPF 35
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54108-8111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	117 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
C30-45 OLEFIN (UNII: 6DWD51M0O8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ISOHEXADECANE (UNII: 918X1OUF1E)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54108-8111-1	1 in 1 BOX	07/15/2020
1		43 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	07/15/2020

Labeler - derma e (148940450)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(54108-8111)