SPL v1
SPL
SPL Set ID 4d78a6bb-2d1f-4ca6-a6f5-37269eb3a4a2
Route
TOPICAL
Published
Effective Date 2013-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3 mg) Titanium Dioxide (2 mg) Zinc Cation
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-09-01

Description

Active Ingredients: Ethylhexyl methoxycinnamate 7.5%, Titanium dioxide 5%, Zinc oxide 5%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Active Ingredients: Ethylhexyl methoxycinnamate 7.5%, Titanium dioxide 5%, Zinc oxide 5%

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 problem 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 the case of getting it into your eyes, you have to wash it immediately.

Active Ingredient

Active Ingredients: Ethylhexyl methoxycinnamate 7.5%, Titanium dioxide 5%, Zinc oxide 5%

Inactive Ingredient

Inactive Ingredients: Water, Cyclopentasiloxane, Butylene glycol, Isoamyl p-methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Betaine, Cetyl ethylhexanoate, Polysorbate 60, Dimethicone, Sodium chloride, Sodium hyaluronate, PEG-40 stearate, Iron oxides, Bentonite, Talc, Stearic acide, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben, Tocopheryl acetate, Perfume, Rubus hirsutus fruit/leaf extract, Camellia Japonica Ovary Powder, Centella asiatica extract, Lavandula angustifolia (Lavender) extract, Glycyrrhiza glabra (Licorice) root extract, Triticum vulgare (Wheat) flour lipids, Allantoin, Lysine HCL, Disodium EDTA, Proline, Sodium ascorbyl phosphate, Linum usitatissimum (Linseed) seed extract, Hibiscus esculentus fruit extract, Aloe barbadensis leaf juice, Arctium lappa root extract, Hibiscus mutabilis flower extract, Corchorus olitorius leaf extract, Dimethyl sulfone

Indications and Usage

Indications and usage: 1. Tighten the lid after using it. 2. Don’t keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3. Use it in the evening after washing face.

Dosage and Administration

Dosage and administration: Apply after washing face. Take a small amount of cream about 1.0-1.5g on to the fingertips and gently massage over the entire face.(cheeks, nostrils, corners, forehead, and the around of eyes, even your hands) Blot face lightly with tissue, and may sleep without washing it.

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 problem 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 the case of getting it into your eyes, you have to wash it immediately.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredients: Ethylhexyl methoxycinnamate 7.5%, Titanium dioxide 5%, Zinc oxide 5%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Water, Cyclopentasiloxane, Butylene glycol, Isoamyl p-methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Betaine, Cetyl ethylhexanoate, Polysorbate 60, Dimethicone, Sodium chloride, Sodium hyaluronate, PEG-40 stearate, Iron oxides, Bentonite, Talc, Stearic acide, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben, Tocopheryl acetate, Perfume, Rubus hirsutus fruit/leaf extract, Camellia Japonica Ovary Powder, Centella asiatica extract, Lavandula angustifolia (Lavender) extract, Glycyrrhiza glabra (Licorice) root extract, Triticum vulgare (Wheat) flour lipids, Allantoin, Lysine HCL, Disodium EDTA, Proline, Sodium ascorbyl phosphate, Linum usitatissimum (Linseed) seed extract, Hibiscus esculentus fruit extract, Aloe barbadensis leaf juice, Arctium lappa root extract, Hibiscus mutabilis flower extract, Corchorus olitorius leaf extract, Dimethyl sulfone

Indications and Usage (INDICATIONS AND USAGE)

Indications and usage: 1. Tighten the lid after using it. 2. Don’t keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3. Use it in the evening after washing face.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Dosage and administration: Apply after washing face. Take a small amount of cream about 1.0-1.5g on to the fingertips and gently massage over the entire face.(cheeks, nostrils, corners, forehead, and the around of eyes, even your hands) Blot face lightly with tissue, and may sleep without washing it.

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

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