Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 55bf9c1f-9c65-7021-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2017-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (1.6 g)
Inactive Ingredients
Water Allantoin Hyaluronate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-08-08
Description

titanium dioxide

Medication Information

Warnings and Precautions

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

1) Occurrence of red spots, swelling, itchiness, and other skin irritation

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

2. Do not use on open wounds, eczema, and other skin irritations

3. Precaution for Storage and Handling

1) Close the lid after use

2) Keep out of reach of infants and children

3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

Indications and Usage

Click end to release product into brush, then apply to areas you want to perfect and brighten around eyes or face. Repeat until desired coverage is achieved, then pat into skin with fingertips to blend flawlessly.

Dosage and Administration

for external use only

Description

titanium dioxide

Section 50565-1

keep out of reach of the children

Section 51727-6

wter butylene glycol, beeswas, etc.

Section 51945-4

Section 55105-1

brighten around eyes or face

Section 55106-9

titanium dioxide

Structured Label Content

Indications and Usage (34067-9)

Click end to release product into brush, then apply to areas you want to perfect and brighten around eyes or face. Repeat until desired coverage is achieved, then pat into skin with fingertips to blend flawlessly.

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

1) Occurrence of red spots, swelling, itchiness, and other skin irritation

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

2. Do not use on open wounds, eczema, and other skin irritations

3. Precaution for Storage and Handling

1) Close the lid after use

2) Keep out of reach of infants and children

3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

wter butylene glycol, beeswas, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

brighten around eyes or face

Section 55106-9 (55106-9)

titanium dioxide

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:23.632218 · Updated: 2026-03-14T22:54:48.761962