SPL v1
SPL
SPL Set ID 966d70e7-06a6-cd69-e053-2a95a90a2ab3
Route
TOPICAL
Published
Effective Date 2019-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (4.9004028 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-11-01

Description

zinc oxide


Medication Information

Warnings and Precautions

1) if there is any abnormal symptom or side effect, such as red spot, swelling and itching when using cosmetlcs or after using due to direct sunlight, consult dermatologists

2) Do not use for wounded areas

3) Precautions for storage and handling

keep out of reach of children, store away from direct sunlight

4) avoid the eye area

Indications and Usage

before foundation BB cream, apply it as a substitute for a primer.

if the foundation you use is dark, mix it with a small amount of sun block to adjust the tone before use

Dosage and Administration

For external use only

Description

zinc oxide

Section 50565-1

Keep out of reach of children

Section 51727-6

water, butylene glycol, cyclopentasiloxane, etc.

Section 51945-4

Section 55105-1

dual functionality for brightening and wrinkle improvement certified

Section 55106-9

zinc oxide


Structured Label Content

Indications and Usage (34067-9)

before foundation BB cream, apply it as a substitute for a primer.

if the foundation you use is dark, mix it with a small amount of sun block to adjust the tone before use

Dosage and Administration (34068-7)

For external use only

Warnings and Precautions (34071-1)

1) if there is any abnormal symptom or side effect, such as red spot, swelling and itching when using cosmetlcs or after using due to direct sunlight, consult dermatologists

2) Do not use for wounded areas

3) Precautions for storage and handling

keep out of reach of children, store away from direct sunlight

4) avoid the eye area

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

water, butylene glycol, cyclopentasiloxane, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

dual functionality for brightening and wrinkle improvement certified

Section 55106-9 (55106-9)

zinc oxide


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)