SPL v1
SPL
SPL Set ID ad7c9932-79bb-4810-a1b0-6e6f0a75da47
Route
TOPICAL
Published
Effective Date 2016-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (1.86 g) Octinoxate (1.80 g) Zinc Cation (1.29 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-05-01

Description

Active ingredient: Titanium Dioxide 4.15%, Ethylhexyl Methoxycinnamate 4.0%, Zinc Oxide 2.88%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Use: Helps prevent and relieve chapped or cracked skin.

Directions: - Clean the skin thoroughly before using - Apply in daily skin care routine

Warnings

Warnings: For external use only. When using this product do not get into eyes. Stop use and ask a doctor if rash occurs. Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children.

Active Ingredient

Active ingredient: Titanium Dioxide 4.15%, Ethylhexyl Methoxycinnamate 4.0%, Zinc Oxide 2.88%

Inactive Ingredient

Inactive Ingredient: Water, Cyclopentasiloxane, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Silica, Bis-PEG/PPG-14/14 Dimethicone, Polymethyl Methacrylate, 4-Methylbenzylidene Camphor, Hexyldecyl Myristoyl Methylaminopropionate, Quaternium-18 Bentonite, Sorbitan Sesquioleate, Tilia Platyphyllos Flower Extract, Anthemis Nobilis Flower Water, Lavandula Angustifolia (Lavender) Flower Water, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Phenoxyethanol, Cetyl PEG/PPG-10/1 Dimethicone, Fragrance, Magnesium Sulfate, Codium Tomentosum Extract, Hydrogen Dimethicone, Aloe Barbadensis Leaf Juice, Enteromorpha Compressa Extract, Nymphaea Alba Flower Extract, Sodium Benzoate, Glycerin, Disodium EDTA, Potassium Sorbate, Pseudoalteromonas Ferment Extract, CI 77492, Alcohol, Gelidium Cartilagineum Extract, Hizikia Fusiforme Extract, Ecklonia Cava Extract, Mesembryanthemum Crystallinum Extract, CI 77491, Citric Acid, Sodium Hyaluronate, Ethylhexylglycerin, PVP, Platinum Powder

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: For external use only. When using this product do not get into eyes. Stop use and ask a doctor if rash occurs. Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children.

Description (DESCRIPTION)

Use: Helps prevent and relieve chapped or cracked skin.

Directions: - Clean the skin thoroughly before using - Apply in daily skin care routine

Active Ingredient (ACTIVE INGREDIENT)

Active ingredient: Titanium Dioxide 4.15%, Ethylhexyl Methoxycinnamate 4.0%, Zinc Oxide 2.88%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredient: Water, Cyclopentasiloxane, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Silica, Bis-PEG/PPG-14/14 Dimethicone, Polymethyl Methacrylate, 4-Methylbenzylidene Camphor, Hexyldecyl Myristoyl Methylaminopropionate, Quaternium-18 Bentonite, Sorbitan Sesquioleate, Tilia Platyphyllos Flower Extract, Anthemis Nobilis Flower Water, Lavandula Angustifolia (Lavender) Flower Water, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Phenoxyethanol, Cetyl PEG/PPG-10/1 Dimethicone, Fragrance, Magnesium Sulfate, Codium Tomentosum Extract, Hydrogen Dimethicone, Aloe Barbadensis Leaf Juice, Enteromorpha Compressa Extract, Nymphaea Alba Flower Extract, Sodium Benzoate, Glycerin, Disodium EDTA, Potassium Sorbate, Pseudoalteromonas Ferment Extract, CI 77492, Alcohol, Gelidium Cartilagineum Extract, Hizikia Fusiforme Extract, Ecklonia Cava Extract, Mesembryanthemum Crystallinum Extract, CI 77491, Citric Acid, Sodium Hyaluronate, Ethylhexylglycerin, PVP, Platinum Powder

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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