Body Shield Dimethicone

Body Shield Dimethicone
SPL v4
SPL
SPL Set ID 8febb45d-a200-702c-e053-2995a90a3e62
Route
TOPICAL
Published
Effective Date 2019-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (50 ug)
Inactive Ingredients
Calcium Pantothenate Silicon Dioxide Cetyl Alcohol Sodium Ascorbyl Phosphate Octenylsuccinic Acid Aloe Vera Leaf Carthamus Tinctorius (safflower) Oleosomes Caprylyl Glycol Proline Glycine Arginine Aspartic Acid Alanine Leucine Tyrosine Trolamine Glycerin Water Maltodextrin Pyridoxine Hydrochloride Hyaluronate Sodium Ginger Lysine Threonine Glutamic Acid Isoleucine Peg-100 Stearate Stearic Acid Butylene Glycol Niacinamide .alpha.-tocopherol Acetate Edetate Disodium Anhydrous Chlorphenesin Histidine Serine Phenoxyethanol Levomenol Valine Phenylalanine Glyceryl Monostearate Kukui Nut Oil Safflower Oil Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-12
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

For external use only.

When using this product

  • do not get into eyes

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

Indications and Usage

Uses

for the treatment and/or prevention of diaper rash

temporarily protects and helps relieve chapped or cracked skin

Dosage and Administration

Directions

  • Cleanse skin with Thera Moisturizing Body Cleanser or Thera Foaming Body Cleanser
  • Apply cream liberally until entire area is covered
  • Apply as needed
Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Section 50566-9

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Section 51727-6

Inactive Ingredients:

Purified Water, Glyceryl Stearate, PEG 100 Stearate, Stearic Acid, Aleurites Moluccana Seed Oil,

Cetyl Alcohol, Glycerin, Butylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil,

Dimethicone Crosspolymer, Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3),

Pyridoxine HCL (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate,

Tocopheryl Acetate (Vitamin E), Disodium EDTA, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract,

Zingiber Officinale (Ginger) Root Extract, Carthamus Tinctorius (Safflower) Oleosomes, Fragrance,

Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Bisabolol, Lysine, Histidine, Arginine, Aspartic Acid,

Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine,

Tyrosine, Phenylalanine, Cysteine, Triethanolamine

Section 51945-4

NDC 68599-0213-4

McKesson

Thera

DIMETHICONE BODY SHIELD

Provides mild skin protection against irritation from chapped or cracked skin.

Single Patient Use

NET CONTENTS 4 fl oz (118 mL)

MFR # 53-DS4

Section 53413-1

Questions?

Call 1-800-777-4908

Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active Ingredient

Dimethicone 5%

Section 60561-8



Store at 40-95ºF (4-35ºC)

Structured Label Content

Indications and Usage (34067-9)

Uses

for the treatment and/or prevention of diaper rash

temporarily protects and helps relieve chapped or cracked skin

Dosage and Administration (34068-7)

Directions

  • Cleanse skin with Thera Moisturizing Body Cleanser or Thera Foaming Body Cleanser
  • Apply cream liberally until entire area is covered
  • Apply as needed
Warnings and Precautions (34071-1)

Warnings

For external use only.

When using this product

  • do not get into eyes

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Section 51727-6 (51727-6)

Inactive Ingredients:

Purified Water, Glyceryl Stearate, PEG 100 Stearate, Stearic Acid, Aleurites Moluccana Seed Oil,

Cetyl Alcohol, Glycerin, Butylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil,

Dimethicone Crosspolymer, Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3),

Pyridoxine HCL (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate,

Tocopheryl Acetate (Vitamin E), Disodium EDTA, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract,

Zingiber Officinale (Ginger) Root Extract, Carthamus Tinctorius (Safflower) Oleosomes, Fragrance,

Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Bisabolol, Lysine, Histidine, Arginine, Aspartic Acid,

Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine,

Tyrosine, Phenylalanine, Cysteine, Triethanolamine

Section 51945-4 (51945-4)

NDC 68599-0213-4

McKesson

Thera

DIMETHICONE BODY SHIELD

Provides mild skin protection against irritation from chapped or cracked skin.

Single Patient Use

NET CONTENTS 4 fl oz (118 mL)

MFR # 53-DS4

Section 53413-1 (53413-1)

Questions?

Call 1-800-777-4908

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active Ingredient

Dimethicone 5%

Section 60561-8 (60561-8)



Store at 40-95ºF (4-35ºC)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:54.081400 · Updated: 2026-03-14T23:04:13.637753