SPL v1
SPL
SPL Set ID bd99a8f7-6300-4d6d-b3ab-f301b3278e16
Route
TOPICAL
Published
Effective Date 2015-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.47 g) Octinoxate (3.15 g) Zinc Cation (1.32 g)
Inactive Ingredients
Water Dipropylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-05-01

Description

Active Ingredients: Titanium Dioxide 9.94%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 2.94%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Active Ingredients: Titanium Dioxide 9.94%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 2.94%

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 9.94%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 2.94%

Inactive Ingredient

Inactive Ingredients: Water, Cyclopentasiloxane, Dipropylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Phenyl Trimethicone, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Arbutin, Hexyldecyl Myristoyl Methylaminopropionate, Hexyl Laurate, Iron Oxides (CI 77492), Sorbitan Sesquioleate, Magnesium Sulfate, Phenoxyethanol, Disteardimonium Hectorite, Isoamyl p-Methoxycinnamate, Silica, Iron Oxides (CI 77491), Tribehenin, Iron Oxides (CI 77499), Aluminum Hydroxide, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Stearic Acid, Triethoxycaprylylsilane, Glyceryl Behenate, Calcium Stearate, Polyglyceryl-6 Octastearate, Fragrance(Parfum), Ethylhexylglycerin, Dimethicone, Disodium EDTA, Adenosine, Water, Butylene Glycol, Ceramide 3, Tremella Fuciformis (Mushroom) Extract, Mica (CI 77019), Glycerin, Melissa Officinalis Leaf Extract, Malva Sylvestris (Mallow) Extract, Achillea Millefolium Extract, Alchemilla Vulgaris Extract, Primula Veris Extract, Mentha Piperita (Peppermint) Leaf Extract, Veronica Officinalis Extract, Ethyl Hexanediol, Oxygen

Indications & Usage

Indication & Usage: After application of skin care products, apply on face using fingertips or sponge.

Dosage & Administration

Dosage & 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 babies and children

Package Label.principal Display Panel

Image of carton


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 9.94%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 2.94%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Water, Cyclopentasiloxane, Dipropylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Phenyl Trimethicone, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Arbutin, Hexyldecyl Myristoyl Methylaminopropionate, Hexyl Laurate, Iron Oxides (CI 77492), Sorbitan Sesquioleate, Magnesium Sulfate, Phenoxyethanol, Disteardimonium Hectorite, Isoamyl p-Methoxycinnamate, Silica, Iron Oxides (CI 77491), Tribehenin, Iron Oxides (CI 77499), Aluminum Hydroxide, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Stearic Acid, Triethoxycaprylylsilane, Glyceryl Behenate, Calcium Stearate, Polyglyceryl-6 Octastearate, Fragrance(Parfum), Ethylhexylglycerin, Dimethicone, Disodium EDTA, Adenosine, Water, Butylene Glycol, Ceramide 3, Tremella Fuciformis (Mushroom) Extract, Mica (CI 77019), Glycerin, Melissa Officinalis Leaf Extract, Malva Sylvestris (Mallow) Extract, Achillea Millefolium Extract, Alchemilla Vulgaris Extract, Primula Veris Extract, Mentha Piperita (Peppermint) Leaf Extract, Veronica Officinalis Extract, Ethyl Hexanediol, Oxygen

Indications & Usage (INDICATIONS & USAGE)

Indication & Usage: After application of skin care products, apply on face using fingertips or sponge.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Dosage & 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)

Image of carton


Advanced Ingredient Data


Raw Label Data

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