SPL v6
SPL
SPL Set ID ab8a70f5-1b3e-48a4-a9f7-ebcb30d527a9
Route
TOPICAL
Published
Effective Date 2025-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (4 g)
Inactive Ingredients
Water Medium-chain Triglycerides Glycerin Polyisobutylene (55000 Mw) Shea Butter Stearyl Stearate Isopropyl Palmitate Cetostearyl Alcohol Cetyl Alcohol Di-ppg-3 Myristyl Ether Adipate Myristyl Myristate Polyoxyl 20 Cetostearyl Ether Docosanol Niacinamide Sodium Pyrrolidone Carboxylate Lactic Acid, Unspecified Form Olive Oil Phenoxyethanol Xanthan Gum Caprylyl Glycol Allantoin Avocado Oil .alpha.-tocopherol Acetate Ethylhexylglycerin Hexylene Glycol Panthenol Edetate Disodium Limonene, (+)- Linalool, (+/-)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-01

Description

Dimethicone 4%

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Dimethicone 4%

Uses
  • temporarily protects and helps relieve chapped or cracked skin
Section 42229-5

Questions? Call 1-800-551-2345 or visit www.jafra.com

Warnings

For external use only

When using this product● do not get into eyes

Stop use and ask a doctor● condition worsens ● symptoms last more than 7 days or clear up and occur again in a few days

Do not use on● deep or puncture wounds ● animal bites ● serious burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions



• apply as needed

Product Label

Active Ingredient

Dimethicone 4%

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Glycerin, Polyisobutene, Butyrospermum Parkii (Shea) Butter, Stearyl Stearate, Isopropyl Palmitate, Cetearyl Alcohol, Cetyl Alcohol, Di-PPG-3 Myristyl Ether Adipate, Myristyl Myristate, Ceteareth-20, Behenyl Alcohol, Niacinamide, Sodium PCA, Lactic Acid, Phenoxyethanol , Xanthan Gum, Fragrance, Limonene, Caprylyl Glycol, Allantoin, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate, Phytosterols, Ethylhexylglycerin, Hexylene Glycol, Panthenol, Olea Europaea (Olive) Fruit Oil, Disodium EDTA, Linalool


Structured Label Content

Uses
  • temporarily protects and helps relieve chapped or cracked skin
Section 42229-5 (42229-5)

Questions? Call 1-800-551-2345 or visit www.jafra.com

Purpose

Skin protectant

Warnings

For external use only

When using this product● do not get into eyes

Stop use and ask a doctor● condition worsens ● symptoms last more than 7 days or clear up and occur again in a few days

Do not use on● deep or puncture wounds ● animal bites ● serious burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions



• apply as needed

Product Label (Product label)

Active Ingredient (Active ingredient)

Dimethicone 4%

Inactive Ingredients (Inactive ingredients)

Water, Caprylic/Capric Triglyceride, Glycerin, Polyisobutene, Butyrospermum Parkii (Shea) Butter, Stearyl Stearate, Isopropyl Palmitate, Cetearyl Alcohol, Cetyl Alcohol, Di-PPG-3 Myristyl Ether Adipate, Myristyl Myristate, Ceteareth-20, Behenyl Alcohol, Niacinamide, Sodium PCA, Lactic Acid, Phenoxyethanol , Xanthan Gum, Fragrance, Limonene, Caprylyl Glycol, Allantoin, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate, Phytosterols, Ethylhexylglycerin, Hexylene Glycol, Panthenol, Olea Europaea (Olive) Fruit Oil, Disodium EDTA, Linalool


Advanced Ingredient Data


Raw Label Data

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