SPL v1
SPL
SPL Set ID 827dfa56-e555-486d-8017-5e72f27d46a8
Route
TOPICAL
Published
Effective Date 2012-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.744 g) Octinoxate (0.48 g) Zinc Oxide (0.235 g)
Inactive Ingredients
Talc Mica Triethylhexanoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-03-01

Description

Active Ingredients: Titanium Dioxide (CI 77891) 6.208%, Ethylhexyl Methoxycinnamate 4%, Zinc Oxide (CI 77947) 1.96%

Indications and Usage

Indication and usage 1. Recap the bottle after use. 2. Avoid exposure to a high or low temperature of direct sunlight

Purpose

Purpose: UVA/UVB Protection

Dosage and Administration

Dosage and administration After take contents off puff, spread carefully depending on your skin texture.


Medication Information

Indications and Usage

Indication and usage

1. Recap the bottle after use.

2. Avoid exposure to a high or low temperature of direct sunlight

Purpose

Purpose: UVA/UVB Protection

Dosage and Administration

Dosage and administration

After take contents off puff, spread carefully depending on your skin texture.

Description

Active Ingredients: Titanium Dioxide (CI 77891) 6.208%, Ethylhexyl Methoxycinnamate 4%, Zinc Oxide (CI 77947) 1.96%

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 dematologists.

2. In case of having problems such as red spots, swelling, itching and irritation during usage

3. In case the above symptoms emerge due to direct exposure to sunlight

4. Please do not apply the skin to areas affected by eczema and dermatitis

Active Ingredient

Active Ingredients: Titanium Dioxide (CI 77891) 6.208%, Ethylhexyl Methoxycinnamate 4%, Zinc Oxide (CI 77947) 1.96%

Inactive Ingredient

Inactive Ingredients: Talc, Mica (CI 77019), Silica, Alumina, Methyl Methacrylate Crosspolymer, Ethylene/Acrylic Acid Copolymer, Triethylhexanoin, Hydrogenated Castor Oil Isostearate, Magnesium Myristate, HDI/Trimethylol Hexyllactone Crosspolymer, Iron Oxides (CI 77492), Dimethicone, Triethoxycaprylylsilane, Methicone, Iron Oxides (CI 77491), Methylparaben, Iron Oxides (CI 77499), Fragrance(Parfum), Butylparaben, Acorus Gramineus Root/Stem Extract, Ultramarines (CI 77007), Morus Alba Bark Extract, Water, Butylene Glycol, Bacillus/Soybean Ferment Extract, Polyperfluoromethylisopropyl Ether, Aloe Barbadensis Leaf Extract, Chrysanthellum Indicum Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Nelumbo Nucifera Flower Extract, Carthamus Tinctorius (Safflower) Flower Extract, Laminaria Saccharina Extract, Glycerin, Camellia Sinensis Leaf Extract, Angelica Keiskei Leaf/Stem Extract, Rubus Suavissimus (Raspberry) Leaf Extract, Glycine Soja (Soybean) Oil, Lecithin, Alcohol Denat. Human Oligopeptide-1

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label. Principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: UVA/UVB Protection

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 dematologists.

2. In case of having problems such as red spots, swelling, itching and irritation during usage

3. In case the above symptoms emerge due to direct exposure to sunlight

4. Please do not apply the skin to areas affected by eczema and dermatitis

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredients: Titanium Dioxide (CI 77891) 6.208%, Ethylhexyl Methoxycinnamate 4%, Zinc Oxide (CI 77947) 1.96%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Talc, Mica (CI 77019), Silica, Alumina, Methyl Methacrylate Crosspolymer, Ethylene/Acrylic Acid Copolymer, Triethylhexanoin, Hydrogenated Castor Oil Isostearate, Magnesium Myristate, HDI/Trimethylol Hexyllactone Crosspolymer, Iron Oxides (CI 77492), Dimethicone, Triethoxycaprylylsilane, Methicone, Iron Oxides (CI 77491), Methylparaben, Iron Oxides (CI 77499), Fragrance(Parfum), Butylparaben, Acorus Gramineus Root/Stem Extract, Ultramarines (CI 77007), Morus Alba Bark Extract, Water, Butylene Glycol, Bacillus/Soybean Ferment Extract, Polyperfluoromethylisopropyl Ether, Aloe Barbadensis Leaf Extract, Chrysanthellum Indicum Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Nelumbo Nucifera Flower Extract, Carthamus Tinctorius (Safflower) Flower Extract, Laminaria Saccharina Extract, Glycerin, Camellia Sinensis Leaf Extract, Angelica Keiskei Leaf/Stem Extract, Rubus Suavissimus (Raspberry) Leaf Extract, Glycine Soja (Soybean) Oil, Lecithin, Alcohol Denat. Human Oligopeptide-1

Indications and Usage (INDICATIONS AND USAGE)

Indication and usage

1. Recap the bottle after use.

2. Avoid exposure to a high or low temperature of direct sunlight

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Dosage and administration

After take contents off puff, spread carefully depending on your skin texture.

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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