SPL v1
SPL
SPL Set ID 392fc83e-eeb1-49de-8c40-7c2ea0c1d2e5
Route
TOPICAL
Published
Effective Date 2016-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.8 g) Octinoxate (0.6 g)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-03-02

Description

Active Ingredient: Titanium Dioxide 7.0%, Ethylhexyl Methoxycinnamate 1.5%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Indications & Usage: 1. Shake before using, apply evenly to clean face after skin care and treatment serum. 2. Tap applied face softly for better absorption. 3. Always replace cap after use

Dosage & Administration: Apply appropriate amount onto face after applying activator or cleansing.

Warnings

Warnings: 1. If the following side effects occur, immediately discontinue use. Before resuming use, consult a dermatologist as continual use may worsen symptoms. A) If red spots, swelling, itching, irritation, or other discomforts occur after using the product. B) If the above symptoms occur on the applied area after exposure to direct sunlight. 2. Do not use on open wounds or on areas of skin exhibiting signs of eczema or dermatitis. 3. Storage and handling precautions A) Keep product out of reach of infants and children. B) Ensure that lid is closed after use. C) Do not store in places subject to high or cold temperatures or under exposure to direct sunlight. D) Use care to avoid eye contact when using this product.

Active Ingredient

Active Ingredient: Titanium Dioxide 7.0%, Ethylhexyl Methoxycinnamate 1.5%

Inactive Ingredient

Inactive Ingredients: Water, Caprylic/Capric Triglyceride, Glycerin, Propylene Glycol, Petrolatum, Cetyl Ethylhexanoate, Cyclopentasiloxane, Cyclohexasiloxane, Cetyl PEG/PPG-10/1Dimethicone, Dimethicone, Beeswax, Centella Asiatica Extract, Aloe Barbadensis Leaf Juice, Biosaccharide Gum-1, Trehalose, Panthenol, Sodium hyaluronate, Sodium Chloride, Sorbitan Sesquioleate, Lavandula Angustifolia (Lavender) Flower Extract, Monarda Didyma Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Freesia Refracta Extract, Chamomilla Recutita(Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Paeonia Suffruticosa Root Extract, Scutellaria Baicalensis Root Extract, Butylene Glycol, Caprylhydroxamic Acid, Caprylyl Glycol, Allantoin, Tocopheryl Acetate, Iron Oxide (CI 77492), Iron Oxide (CI 77491), Iron Oxide (CI 77499), Triethoxycaprylylsilane, Talc, BHT, Disodium EDTA, Fragrance

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: 1. If the following side effects occur, immediately discontinue use. Before resuming use, consult a dermatologist as continual use may worsen symptoms. A) If red spots, swelling, itching, irritation, or other discomforts occur after using the product. B) If the above symptoms occur on the applied area after exposure to direct sunlight. 2. Do not use on open wounds or on areas of skin exhibiting signs of eczema or dermatitis. 3. Storage and handling precautions A) Keep product out of reach of infants and children. B) Ensure that lid is closed after use. C) Do not store in places subject to high or cold temperatures or under exposure to direct sunlight. D) Use care to avoid eye contact when using this product.

Description (DESCRIPTION)

Indications & Usage: 1. Shake before using, apply evenly to clean face after skin care and treatment serum. 2. Tap applied face softly for better absorption. 3. Always replace cap after use

Dosage & Administration: Apply appropriate amount onto face after applying activator or cleansing.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Titanium Dioxide 7.0%, Ethylhexyl Methoxycinnamate 1.5%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Water, Caprylic/Capric Triglyceride, Glycerin, Propylene Glycol, Petrolatum, Cetyl Ethylhexanoate, Cyclopentasiloxane, Cyclohexasiloxane, Cetyl PEG/PPG-10/1Dimethicone, Dimethicone, Beeswax, Centella Asiatica Extract, Aloe Barbadensis Leaf Juice, Biosaccharide Gum-1, Trehalose, Panthenol, Sodium hyaluronate, Sodium Chloride, Sorbitan Sesquioleate, Lavandula Angustifolia (Lavender) Flower Extract, Monarda Didyma Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Freesia Refracta Extract, Chamomilla Recutita(Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Paeonia Suffruticosa Root Extract, Scutellaria Baicalensis Root Extract, Butylene Glycol, Caprylhydroxamic Acid, Caprylyl Glycol, Allantoin, Tocopheryl Acetate, Iron Oxide (CI 77492), Iron Oxide (CI 77491), Iron Oxide (CI 77499), Triethoxycaprylylsilane, Talc, BHT, Disodium EDTA, Fragrance

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


Advanced Ingredient Data


Raw Label Data

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