Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 7fe49112-4180-415c-a380-768a8d6b2185
Route
TOPICAL
Published
Effective Date 2023-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (10 mg)
Inactive Ingredients
Water Cyclomethicone 5 Cyclomethicone 6 Niacinamide Sodium Chloride Polyglyceryl-4 Isostearate Hexyl Laurate Phenoxyethanol Ceramide 3 Ceramide 6 Ii Ceramide 1 Carbomer Homopolymer, Unspecified Type Methylparaben Sodium Lauroyl Lactylate Cholesterol Propylparaben Phytosphingosine Hyaluronic Acid Xanthan Gum Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2017-12-12 Until 2023-12-01
Description

Dimethicone 1%

Purpose

Skin protectant

Medication Information

Purpose

Skin protectant

Description

Dimethicone 1%

Use

helps prevent and temporarily protects chafed, chapped or cracked skin

Section 51945-4

Warnings

For external use only

Directions

apply as needed

Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient

Dimethicone 1%

Inactive Ingredients

water, cyclopentasiloxane, aluminum/magnesium hydroxide stearate, cyclohexasiloxane, niacinamide, sodium chloride, polyglyceryl-4 isostearate, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, phenoxyethanol, ceramide NP, ceramide AP, ceramide EOP, carbomer, methylparaben, sodium lauroyl lactylate, cholesterol,. Propylparaben, hydrolyzed hyaluronic acid, phytosphingosine, xanthan gum, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate

Questions Or Comments?

Toll-free number 1-888-768-2915

www.cerave.com

When Using This Product

do not get into eyes

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
Keep Out of Reach of Children.

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

Structured Label Content

Use

helps prevent and temporarily protects chafed, chapped or cracked skin

Section 51945-4 (51945-4)

Purpose

Skin protectant

Warnings

For external use only

Directions

apply as needed

Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient (Active ingredient)

Dimethicone 1%

Inactive Ingredients

water, cyclopentasiloxane, aluminum/magnesium hydroxide stearate, cyclohexasiloxane, niacinamide, sodium chloride, polyglyceryl-4 isostearate, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, phenoxyethanol, ceramide NP, ceramide AP, ceramide EOP, carbomer, methylparaben, sodium lauroyl lactylate, cholesterol,. Propylparaben, hydrolyzed hyaluronic acid, phytosphingosine, xanthan gum, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate

Questions Or Comments? (Questions or comments?)

Toll-free number 1-888-768-2915

www.cerave.com

When Using This Product (When using this product)

do not get into eyes

Stop Use and Ask A Doctor If (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
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:36.501505 · Updated: 2026-03-14T23:02:15.001245