Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 4d1a3793-5a98-4aec-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (7.4 g)
Inactive Ingredients
Titanium Dioxide .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2017-04-01
Description

DIMETHICONE

Medication Information

Warnings and Precautions

Caution：

1. If the following symptoms occur after using the product , stop using the product immediately and consult with a dermatologist

(1) Occurrence of red spots, swelling, itchiness, and other skin stimulation.

(2) If the symptoms above occur after the application area being exposed to direct sunlight

2. Do not use on wounds.

3. Precaution for Storage and Handling

(1) Keep out of reach of infants and children

(2) Do not store in a place exposed to direct sunlight.

Indications and Usage

Take suitable amount of product and put on the lip.

Dosage and Administration

for external use only

Description

DIMETHICONE

Section 50565-1

keep out of reach of the children

Section 51727-6

ISONONYL ISONONANOATE, PHENYL TRIMETHICONE, SILICA, JOJOBA ESTERS, TOCOPHERYL ACETATE, TITANIUM DIOXIDE, ETC.

Section 51945-4

Section 55105-1

LIP COLOR

Section 55106-9

DIMETHICONE

Structured Label Content

Indications and Usage (34067-9)

Take suitable amount of product and put on the lip.

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

Caution：

1. If the following symptoms occur after using the product , stop using the product immediately and consult with a dermatologist

(1) Occurrence of red spots, swelling, itchiness, and other skin stimulation.

(2) If the symptoms above occur after the application area being exposed to direct sunlight

2. Do not use on wounds.

3. Precaution for Storage and Handling

(1) Keep out of reach of infants and children

(2) Do not store in a place exposed to direct sunlight.

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

ISONONYL ISONONANOATE, PHENYL TRIMETHICONE, SILICA, JOJOBA ESTERS, TOCOPHERYL ACETATE, TITANIUM DIOXIDE, ETC.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

LIP COLOR

Section 55106-9 (55106-9)

DIMETHICONE

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:18.274989 · Updated: 2026-03-14T22:54:41.714370