SPL v1
SPL
SPL Set ID a2d586e2-352e-4fea-a95e-85b089f1dda3
Route
TOPICAL
Published
Effective Date 2020-10-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (2.7 g)
Inactive Ingredients
Lanolin Propylparaben Polyoxyl 20 Cetostearyl Ether Citric Acid Monohydrate Diazolidinyl Urea Glycerin Hydroxyethyl Cellulose (4000 Mpa.s At 1%) Methylparaben Palm Kernel Acid Propylene Glycol Sodium Benzoate Copovidone K25-31 Edetate Sodium .alpha.-tocopherol Acetate Trolamine Aloe Vera Leaf Water Cetyl Alcohol Isobutane Isopropyl Myristate Palmitic Acid Perfluoropolymethylisopropyl Ether Potassium Sorbate Propane Butane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-10-09
Description

Dimethicone, 2.7%

Purpose

Skin protectant

Medication Information

Purpose

Skin protectant

Description

Dimethicone, 2.7%

Uses
  • Helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin
  • Helps prevent and protect from the drying effects of wind and cold weather
Warnings

For external use only

Flammable:

  • Do not use near flame or spark or while smoking
  • Contents under pressure
  • Do not puncture or incinerate
  • Do not store at temperature above 120oF
Directions
  • Apply as needed
  • Children under 6 months: ask a doctor
  • Wash and dry skin area
  • Shake can vigorously
  • Invert can and apply "golf ball" sized amount in palm
  • Rub thoroughly onto the skin
  • Allow to dry
Do Not Use On:
  • deep or puncture wounds
  • animal bites
  • serious burns
  • keep out of reach of children
Active Ingredient(s)

Dimethicone, 2.7%

Inactive Ingredients

Water, Propane, Butane, Palmitic acid, Palm Kernal acid, Isopropyl Myrisate, Glycerin, VP/VA Copolymer, Isobutane, Triethanolamine, Cetyl Alcohol, Cetearyl Alcohol, Ceteareth-20, Hydroxyethylcellulose, Perfluorianted Polyether, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Lanolin, Tetrasodium EDTA, Propylene Glycol Diazolindinyl Urea, Methylparaben, Propylparaben, Sodium Benzoate, Potassium Sorbate, Citric Acid

Package Label.principal Display Panel

Derma Shield 2oz Aerosol USA

Derma Shield 6oz Aerosol USA

Derma Shield 17oz Aerosol USA

Structured Label Content

Uses
  • Helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin
  • Helps prevent and protect from the drying effects of wind and cold weather
Purpose

Skin protectant

Warnings

For external use only

Flammable:

  • Do not use near flame or spark or while smoking
  • Contents under pressure
  • Do not puncture or incinerate
  • Do not store at temperature above 120oF
Directions
  • Apply as needed
  • Children under 6 months: ask a doctor
  • Wash and dry skin area
  • Shake can vigorously
  • Invert can and apply "golf ball" sized amount in palm
  • Rub thoroughly onto the skin
  • Allow to dry
Do Not Use On: (Do not use on:)
  • deep or puncture wounds
  • animal bites
  • serious burns
  • keep out of reach of children
Active Ingredient(s)

Dimethicone, 2.7%

Inactive Ingredients (Inactive ingredients)

Water, Propane, Butane, Palmitic acid, Palm Kernal acid, Isopropyl Myrisate, Glycerin, VP/VA Copolymer, Isobutane, Triethanolamine, Cetyl Alcohol, Cetearyl Alcohol, Ceteareth-20, Hydroxyethylcellulose, Perfluorianted Polyether, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Lanolin, Tetrasodium EDTA, Propylene Glycol Diazolindinyl Urea, Methylparaben, Propylparaben, Sodium Benzoate, Potassium Sorbate, Citric Acid

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Derma Shield 2oz Aerosol USA

Derma Shield 6oz Aerosol USA

Derma Shield 17oz Aerosol USA

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:57.554724 · Updated: 2026-03-14T22:58:45.636917