Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 84a3299d-9b98-492e-a83f-ebd72ec58f8d
Route
TOPICAL
Published
Effective Date 2019-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (30 mg)
Inactive Ingredients
.alpha.-bisabolol, (+/-)- Caprylhydroxamic Acid Caprylyl Glycol Ceramide Np Copper Pidolate Methylsilanol Pca Cyclomethicone 6 Cyclomethicone 5 Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Dimethiconol (2000 Cst) Glycerin Isohexadecane Isononyl Isononanoate Lauryl Peg/ppg-18/18 Methicone Propyl Gallate Polysorbate 20 Saccharomyces Cerevisiae Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-06-20

Description

Dimethicone 3%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Dimethicone 3%

Uses:
  • Temporarily protects and helps relieve chapped or cracked skin.
  • Helps protect from the drying effects of wind and cold weather.
Section 50565-1

Keep out of the reach of children.

Purpose:

Skin Protectant

Warnings:
  • For external use only.
Directions:
  • Gently cleanse and dry affected area
  • Apply liberally to affected area as needed
Do Not Use On:
  • deep puncture wounds
  • animal bites
  • serious burns
Active Ingredients:

Dimethicone 3%

Inactive Ingredients:

Bisabolol, Caprylhydroxamic Acid, Caprylyl Glycol, Ceramide 3, Copper PCA Methylsilanol, Cydohexasiloxane, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Glycerin, Isohexadecane, Isononyl Isononanoate, Lauryl PEG/PPG-18/18 Hydrogen Dimethicone, Propyl Gallate, Polysorbate 20, Saccharomyces/ Copper Ferment, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Vinyl Dimethicone/Hydrogen Dimethicone Silsesquioxane Crosspolymer, Water

When Using This Product:
  • Do not get into eyes
Stop Use and Ask Doctor If:
  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach Out Children.

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

Principal Display Panel – Bottle Label

TIZO ®

PHOTOCEUTICAL ®

ENVIRONMENTAL

SKIN PROTECTANT

Dimethicone 3%

Copper Peptides

Bisabolol

featuring

SKIN FIRM TECHNOLOGY ®

1 Fl. Oz./29 ml

Principal Display Panel – Carton Label

ENVIRONMENTAL

SKIN PROTECTANT

TIZO ®

PHOTOCEUTICAL ®

Especially effective against

environmental damage

Dimethicone 3%

Copper Peptides

Bisabolol

featuring

SKIN FIRM TECHNOLOGY ®

1 Fl. Oz./29 ml


Structured Label Content

Uses:
  • Temporarily protects and helps relieve chapped or cracked skin.
  • Helps protect from the drying effects of wind and cold weather.
Section 50565-1 (50565-1)

Keep out of the reach of children.

Purpose:

Skin Protectant

Warnings:
  • For external use only.
Directions:
  • Gently cleanse and dry affected area
  • Apply liberally to affected area as needed
Do Not Use On: (Do not use on:)
  • deep puncture wounds
  • animal bites
  • serious burns
Active Ingredients:

Dimethicone 3%

Inactive Ingredients:

Bisabolol, Caprylhydroxamic Acid, Caprylyl Glycol, Ceramide 3, Copper PCA Methylsilanol, Cydohexasiloxane, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Glycerin, Isohexadecane, Isononyl Isononanoate, Lauryl PEG/PPG-18/18 Hydrogen Dimethicone, Propyl Gallate, Polysorbate 20, Saccharomyces/ Copper Ferment, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Vinyl Dimethicone/Hydrogen Dimethicone Silsesquioxane Crosspolymer, Water

When Using This Product: (When using this product:)
  • Do not get into eyes
Stop Use and Ask Doctor If: (Stop use and ask doctor if:)
  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach Out Children. (Keep out of reach out children.)

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

Principal Display Panel – Bottle Label

TIZO ®

PHOTOCEUTICAL ®

ENVIRONMENTAL

SKIN PROTECTANT

Dimethicone 3%

Copper Peptides

Bisabolol

featuring

SKIN FIRM TECHNOLOGY ®

1 Fl. Oz./29 ml

Principal Display Panel – Carton Label

ENVIRONMENTAL

SKIN PROTECTANT

TIZO ®

PHOTOCEUTICAL ®

Especially effective against

environmental damage

Dimethicone 3%

Copper Peptides

Bisabolol

featuring

SKIN FIRM TECHNOLOGY ®

1 Fl. Oz./29 ml


Advanced Ingredient Data


Raw Label Data

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