SPL v1
SPL
SPL Set ID 8be3d0f5-1ce6-48c4-8599-1be07012196c
Route
TOPICAL
Published
Effective Date 2013-08-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.33 g) Octinoxate (1.2 g) Zinc Cation (0.59 g)
Inactive Ingredients
Mica Talc

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-10-01

Description

Active Ingredients: Titanium Dioxide 11.64%, Ethylhexyl Methoxycinnamate 6.00%, Zinc Oxide 2.94%

Indications and Usage

INDICATIONS AND USAGE: After base make-up, apply powder to the puff and apply gently. Application order : Chick - Forehead - Nose - Chin

Purpose

PURPOSE: SUNSCREEN

Dosage and Administration

DOSAGE AND ADMINISTRATION: Take an adequate amount of this product.


Medication Information

Indications and Usage

INDICATIONS AND USAGE: After base make-up, apply powder to the puff and apply gently. Application order : Chick - Forehead - Nose - Chin

Purpose

PURPOSE: SUNSCREEN

Dosage and Administration

DOSAGE AND ADMINISTRATION: Take an adequate amount of this product.

Description

Active Ingredients: Titanium Dioxide 11.64%, Ethylhexyl Methoxycinnamate 6.00%, Zinc Oxide 2.94%

Warnings

Warnings:

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 11.64%, Ethylhexyl Methoxycinnamate 6.00%, Zinc Oxide 2.94%

Inactive Ingredient

INACTIVE INGREDIENT:

Mica (CI 77019), Talc, Alumina, Silica, Hexyl Laurate, HDI/Trimethylol Hexyllactone Crosspolymer, Dimethicone, Iron Oxides (CI 77492), Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Methicone, Magnesium Myristate, Hydrogenated Lecithin, Iron Oxides (CI 77491), Methylparaben, Iron Oxides (CI 77499), Propylparaben, Fragrance(Parfum), Ultramarines (CI 77007), Water, Butylene Glycol, Calcium Carbonate, Hydrolyzed Antler Velvet, Caprylic/Capric Triglyceride, Triethoxycaprylylsilane, Phenoxyethanol, Poria Cocos Extract, Rehmannia Glutinosa Root Extract, Citrus Unshiu Peel Extract, Lithospermum Erythrorhizon Root Extract, Coptis Japonica Root Extract, Glycerin, Trichosanthes Kirilowii Root Extract, Camellia Sinensis Leaf Extract, Zizyphus Jujuba Fruit Extract, Phellodendron Amurense Bark Extract, Rosa Davurica Bud Extract, Ethylhexylglycerin, Ligularia Fishceria Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Oenothera Biennis (Evening Primrose) Seed Extract, Angelica Gigas Root Extract, Prunus Mume Flower Extract, Atractyloides Japonica Rhizome Extract, Cinnamomum Cassia Bark Extract, Panax Ginseng Root Extract, Paeonia Lactiflora Root Extract, Cnidium Officinale Root Extract, Nelumbo Nucifera Flower Extract, Disodium EDTA, Prunus Mume Fruit Extract, Lactic Acid, Citric Acid

Keep Out of Reach of Children

Keep out of reach of children:

Keep out of reach of babies and children

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

PURPOSE: SUNSCREEN

Warnings (WARNINGS)

Warnings:

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 11.64%, Ethylhexyl Methoxycinnamate 6.00%, Zinc Oxide 2.94%

Inactive Ingredient (INACTIVE INGREDIENT)

INACTIVE INGREDIENT:

Mica (CI 77019), Talc, Alumina, Silica, Hexyl Laurate, HDI/Trimethylol Hexyllactone Crosspolymer, Dimethicone, Iron Oxides (CI 77492), Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Methicone, Magnesium Myristate, Hydrogenated Lecithin, Iron Oxides (CI 77491), Methylparaben, Iron Oxides (CI 77499), Propylparaben, Fragrance(Parfum), Ultramarines (CI 77007), Water, Butylene Glycol, Calcium Carbonate, Hydrolyzed Antler Velvet, Caprylic/Capric Triglyceride, Triethoxycaprylylsilane, Phenoxyethanol, Poria Cocos Extract, Rehmannia Glutinosa Root Extract, Citrus Unshiu Peel Extract, Lithospermum Erythrorhizon Root Extract, Coptis Japonica Root Extract, Glycerin, Trichosanthes Kirilowii Root Extract, Camellia Sinensis Leaf Extract, Zizyphus Jujuba Fruit Extract, Phellodendron Amurense Bark Extract, Rosa Davurica Bud Extract, Ethylhexylglycerin, Ligularia Fishceria Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Oenothera Biennis (Evening Primrose) Seed Extract, Angelica Gigas Root Extract, Prunus Mume Flower Extract, Atractyloides Japonica Rhizome Extract, Cinnamomum Cassia Bark Extract, Panax Ginseng Root Extract, Paeonia Lactiflora Root Extract, Cnidium Officinale Root Extract, Nelumbo Nucifera Flower Extract, Disodium EDTA, Prunus Mume Fruit Extract, Lactic Acid, Citric Acid

Indications and Usage (INDICATIONS AND USAGE)

INDICATIONS AND USAGE: After base make-up, apply powder to the puff and apply gently. Application order : Chick - Forehead - Nose - Chin

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:

Keep out of reach of babies and children

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)