Scar Gel

Scar Gel
SPL v1
SPL
SPL Set ID 8cd263aa-a54b-4c55-b3e2-6f6763987d4a
Route
TOPICAL
Published
Effective Date 2024-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (117 mg)
Inactive Ingredients
Allantoin C30-45 Alkyl Methicone C30-45 Olefin Medium-chain Triglycerides Caprylyl Trisiloxane Diethylhexyl Succinate Dimethicone Dimethicone/bis-isobutyl Ppg-20 Crosspolymer Glyceryl Dibehenate Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Isohexadecane Isostearic Acid Lecithin, Sunflower Panthenol Phenoxyethanol Polyglyceryl-3 Pentaricinoleate Polyhydroxystearic Acid Stearate Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-15

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Warnings

For external use only

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
Active Ingredient

Zinc Oxide 11.7% }

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

Principal Display Panel 43 G Tube Box

THERAPEUTIC

• 100% VEGAN • SOY-FREE •

SPF

35

CRUELTY-FREE

DERMA•E

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


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Purpose

Sunscreen

Warnings

For external use only

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
Active Ingredient

Zinc Oxide 11.7% }

Other Information (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? (Questions or comments?)

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

Principal Display Panel 43 G Tube Box (PRINCIPAL DISPLAY PANEL - 43 g Tube Box)

THERAPEUTIC

• 100% VEGAN • SOY-FREE •

SPF

35

CRUELTY-FREE

DERMA•E

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


Advanced Ingredient Data


Raw Label Data

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