SPL v2
SPL
SPL Set ID 5ac58ba5-5f2e-4c86-911d-9a50af44a00e
Route
TOPICAL
Published
Effective Date 2018-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (3.5 mg) Zinc Cation Octinoxate
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-06-01

Description

Active Ingredients: Titanium Dioxide 7%, Zinc Oxide 7%, Ethylhexyl Methoxycinnamate 7%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Active Ingredients: Titanium Dioxide 7%, Zinc Oxide 7%, Ethylhexyl Methoxycinnamate 7%

Warnings

Warning:

1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.

1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.

2) In case of having the same symptoms above on the part you put this product on by direct sunlight.

2. you are banned to use it on the part where you have a scar, eczema, or dermatitis.

3. In case of getting it into your eyes, you have to wash it immediately.

Active Ingredient

Active Ingredients: Titanium Dioxide 7%, Zinc Oxide 7%, Ethylhexyl Methoxycinnamate 7%

Inactive Ingredient

Inactive Ingredients:

Water,Cyclopentasiloxane,Cyclohexasiloxane,Glycerin,Butylene Glycol Dicaprylate/Dicaprate, Phenyl Trimethicone,Mica (CI 77019),Cetyl PEG/PPG-10/1 Dimethicone,Arbutin,Pentylene Glycol,Talc,Dicaprylyl Carbonate,Caprylyl Methicone,Disteardimonium Hectorite,Sodium Chloride,Butylene Glycol,Sorbitan Isostearate,Tribehenin,Hexyl Laurate,Ceresin,Iron Oxides (CI 77492),Snail Secretion Filtrate,Dimethicone,Phenoxyethanol,Dimethicone Crosspolymer, Fragrance(Parfum),Iron Oxides (CI 77491),Iron Oxides (CI 77499),Ethylhexylglycerin, Hydrogenated Castor Oil Isostearate,Adenosine,Disodium EDTA,Triethoxycaprylylsilane,Ethyl Hexanediol,Helianthus Annuus (Sunflower) Seed Oil,Centella Asiatica Extract,Glycyrrhiza Glabra (Licorice) Root Extract,Angelica

Gigas Root Extract,Scutellaria Baicalensis Root Extract, Chrysanthemum Morifolium Flower Extract,Eucommia Ulmoides Extract,Ophiopogon Japonicus Root Extract,Artemisia Princeps Leaf Extract,Cnidium Officinale Root Extract, Gardenia Florida Fruit Extract, Polygonum Multiflorum Root Extract, Carthamus Tinctorius (Safflower) Flower Extract,Astragalus Membranaceus Root Extract,Coptis Chinensis Root Extract,Phellodendron Amurense Bark Extract,Cassia Angustifolia Seed Polysaccharide, Portulaca Oleracea Extract,Origanum Vulgare Leaf Extract,Salix Alba (Willow) Bark Extract, Chamaecyparis Obtusa Leaf Extract, Cinnamomum Cassia Bark Extract,Lactobacillus/Soybean Ferment Extract

Indications and Usage

Indication and Usage: After skincare, apply appropriate amount on all over the face.

Dosage and Administration

Dosage and Administration : Take an adequate amount of this product.

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warning:

1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.

1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.

2) In case of having the same symptoms above on the part you put this product on by direct sunlight.

2. you are banned to use it on the part where you have a scar, eczema, or dermatitis.

3. In case of getting it into your eyes, you have to wash it immediately.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredients: Titanium Dioxide 7%, Zinc Oxide 7%, Ethylhexyl Methoxycinnamate 7%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

Water,Cyclopentasiloxane,Cyclohexasiloxane,Glycerin,Butylene Glycol Dicaprylate/Dicaprate, Phenyl Trimethicone,Mica (CI 77019),Cetyl PEG/PPG-10/1 Dimethicone,Arbutin,Pentylene Glycol,Talc,Dicaprylyl Carbonate,Caprylyl Methicone,Disteardimonium Hectorite,Sodium Chloride,Butylene Glycol,Sorbitan Isostearate,Tribehenin,Hexyl Laurate,Ceresin,Iron Oxides (CI 77492),Snail Secretion Filtrate,Dimethicone,Phenoxyethanol,Dimethicone Crosspolymer, Fragrance(Parfum),Iron Oxides (CI 77491),Iron Oxides (CI 77499),Ethylhexylglycerin, Hydrogenated Castor Oil Isostearate,Adenosine,Disodium EDTA,Triethoxycaprylylsilane,Ethyl Hexanediol,Helianthus Annuus (Sunflower) Seed Oil,Centella Asiatica Extract,Glycyrrhiza Glabra (Licorice) Root Extract,Angelica

Gigas Root Extract,Scutellaria Baicalensis Root Extract, Chrysanthemum Morifolium Flower Extract,Eucommia Ulmoides Extract,Ophiopogon Japonicus Root Extract,Artemisia Princeps Leaf Extract,Cnidium Officinale Root Extract, Gardenia Florida Fruit Extract, Polygonum Multiflorum Root Extract, Carthamus Tinctorius (Safflower) Flower Extract,Astragalus Membranaceus Root Extract,Coptis Chinensis Root Extract,Phellodendron Amurense Bark Extract,Cassia Angustifolia Seed Polysaccharide, Portulaca Oleracea Extract,Origanum Vulgare Leaf Extract,Salix Alba (Willow) Bark Extract, Chamaecyparis Obtusa Leaf Extract, Cinnamomum Cassia Bark Extract,Lactobacillus/Soybean Ferment Extract

Indications and Usage (INDICATIONS AND USAGE)

Indication and Usage: After skincare, apply appropriate amount on all over the face.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Dosage and Administration : Take an adequate amount of this product.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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