ab8a70f5-1b3e-48a4-a9f7-ebcb30d527a9

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

Purpose

Skin protectant

Description

Dimethicone 4%


Medication Information

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.

Uses
  • temporarily protects and helps relieve chapped or cracked skin
Purpose

Skin protectant

Directions



• apply as needed

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

Description

Dimethicone 4%

Section 42229-5

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

Product Label

Active Ingredient

Dimethicone 4%


Structured Label Content

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.

Uses
  • temporarily protects and helps relieve chapped or cracked skin
Purpose

Skin protectant

Directions



• apply as needed

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

Section 42229-5 (42229-5)

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

Product Label (Product label)

Active Ingredient (Active ingredient)

Dimethicone 4%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)