Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 01e80959-7976-4017-8767-c5146fda0c2a
Route
TOPICAL
Published
Effective Date 2014-07-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (15.004 g)
Inactive Ingredients
Dimethicone Aluminum Hydroxide Hyaluronate Sodium Glycerin Bismuth Oxychloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-07-03

Description

zinc oxide


Medication Information

Warnings and Precautions

1. If following symptoms occur, stop use and consult a doctor : red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.

2. Do not use on scarred skin, or if you have dermatitis or eczema

3. Keep the cap close on its product

4. Keep away from direct sunlight or heat.

5. This product blocks UVA rays and ultraviolet protection effectiveness have been measured by the Food and Drug Administration methods and standards



Indications and Usage

Apply it to your face after all of your basic skincare. If you need better UV protect effect, apply it more whenever and wherever needed



Dosage and Administration

for topical use only



Description

zinc oxide

Section 50565-1

keep out of reach of the children



Section 51727-6

Mica,Silica ,Triethoxycaprylylsilane,Iron Oxides,Dimethicone,Aluminum Hydroxide,Glycerine,

Iron Oxides,Methicone,Bismuth Oxychloride,Iron Oxides,Hydrolyzed Algin,Laminaria Digitata Extract,

Phormidium Persicinum Extract,Undaria Pinnatifida Extract  ,Plankton extract,Phenethyl Alcohol  ,

Chlorella vulgaris extract,Pancratium maritimum extract,Crithmum Maritimum Extract,

Helichrysum italicum extract, Ulex europaeus leaf/root/stem extract



Section 51945-4
Section 55105-1

UVA/UVB protection



Section 55106-9

zinc oxide




Structured Label Content

Indications and Usage (34067-9)

Apply it to your face after all of your basic skincare. If you need better UV protect effect, apply it more whenever and wherever needed



Dosage and Administration (34068-7)

for topical use only



Warnings and Precautions (34071-1)

1. If following symptoms occur, stop use and consult a doctor : red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.

2. Do not use on scarred skin, or if you have dermatitis or eczema

3. Keep the cap close on its product

4. Keep away from direct sunlight or heat.

5. This product blocks UVA rays and ultraviolet protection effectiveness have been measured by the Food and Drug Administration methods and standards



Section 50565-1 (50565-1)

keep out of reach of the children



Section 51727-6 (51727-6)

Mica,Silica ,Triethoxycaprylylsilane,Iron Oxides,Dimethicone,Aluminum Hydroxide,Glycerine,

Iron Oxides,Methicone,Bismuth Oxychloride,Iron Oxides,Hydrolyzed Algin,Laminaria Digitata Extract,

Phormidium Persicinum Extract,Undaria Pinnatifida Extract  ,Plankton extract,Phenethyl Alcohol  ,

Chlorella vulgaris extract,Pancratium maritimum extract,Crithmum Maritimum Extract,

Helichrysum italicum extract, Ulex europaeus leaf/root/stem extract



Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

UVA/UVB protection



Section 55106-9 (55106-9)

zinc oxide




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)