DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Titanium Dioxide (1.36 g) Octinoxate (1.05 g) Octisalate (0.60 g)

Inactive Ingredients

Dimethicone Dipropylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2018-02-01

Medication Information

Purpose

Purpose: Sunscreen

Description

Uses:

Helps prevent sunburn

Directions:

Take a proper amount of the product and spread it evenly over the entire face.

Warnings

Warnings:

For external use only

Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

Replace the cap after use.

Keep out of reach of children.

Active Ingredient

Active ingredients: Titanium Dioxide 9.12%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 4.00%

Inactive Ingredient

Inactive Ingredients:

Inactive ingredients: Myrothamnus Flabellifolia Callus Culture Extract, Dimethicone, Dipropylene Glycol, Isoamyl p-Methoxycinnamate, Niacinamide, 1,2-Hexanediol, Cetyl PEG/PPG-10/1 Dimethicone, Water, Sodium Chloride, Beeswax, Hydroxyacetophenone, CI 77492, Diisostearyl Malate, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Sorbitan Sesquioleate, CI 77491, Chamomilla Recutita (Matricaria) Flower Extract, Fragrance, Butylene Glycol, Sodium Citrate, Glyceryl Caprylate, CI 77499, Ethylhexylglycerin, Glycerin, Adenosine, Disodium EDTA, Triethoxycaprylylsilane, Macadamia Ternifolia Seed Oil, Hydrogenated Lecithin, Cholesterol, Aluminum Hydroxide, Mica, Polymethyl Methacrylate, Rose Extract, Diospyros Kaki Leaf Extract, Vitis Vinifera (Grape) Fruit Extract, Brassica Campestris (Rapeseed) Sterols, Lavandula Angustifolia (Lavender) Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Borago Officinalis Extract, Centaurea Cyanus Flower Extract, Salvia Sclarea (Clary) Extract, Hyacinthus Orientalis Extract, Camellia Sinensis Leaf Extract, Castanea Crenata (Chestnut) Shell Extract, Zanthoxylum Schinifolium Leaf Extract, Coffea Arabica (Coffee) Seed Extract, Polygonum Cuspidatum Extract, Carthamus Tinctorius (Safflower) Flower Extract, Honey Extract, Eriobotrya Japonica Leaf Extract, Talc, Sucrose, Ceramide NP, Stearic Acid, Polyglutamic Acid, Royal Jelly Extract, Propolis Extract, Oleic Acid, Tocopheryl Acetate, Mineral Salts, sh-Decapeptide-9, Polysorbate 20, Lecithin, Acetyl Hexapeptide-8, Nicotinoyl Tripeptide-1, Nicotinoyl Octapeptide-9, sh-Octapeptide-4, Pentapeptide-37, Decapeptide-12, Caffeoyl Tripeptide-1, sh-Oligopeptide-1, Sh-polypeptide-22, sh-Oligopeptide-2, Sh-polypeptide-5, Sh-polypeptide-60, Sh-polypeptide-2, sh-Polypeptide-4, sh-Polypeptide-11

Package Label.principal Display Panel

Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings:

For external use only

Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

Replace the cap after use.

Keep out of reach of children.

Description (DESCRIPTION)

Uses:

Helps prevent sunburn

Directions:

Take a proper amount of the product and spread it evenly over the entire face.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Titanium Dioxide 9.12%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 4.00%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

Inactive ingredients: Myrothamnus Flabellifolia Callus Culture Extract, Dimethicone, Dipropylene Glycol, Isoamyl p-Methoxycinnamate, Niacinamide, 1,2-Hexanediol, Cetyl PEG/PPG-10/1 Dimethicone, Water, Sodium Chloride, Beeswax, Hydroxyacetophenone, CI 77492, Diisostearyl Malate, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Sorbitan Sesquioleate, CI 77491, Chamomilla Recutita (Matricaria) Flower Extract, Fragrance, Butylene Glycol, Sodium Citrate, Glyceryl Caprylate, CI 77499, Ethylhexylglycerin, Glycerin, Adenosine, Disodium EDTA, Triethoxycaprylylsilane, Macadamia Ternifolia Seed Oil, Hydrogenated Lecithin, Cholesterol, Aluminum Hydroxide, Mica, Polymethyl Methacrylate, Rose Extract, Diospyros Kaki Leaf Extract, Vitis Vinifera (Grape) Fruit Extract, Brassica Campestris (Rapeseed) Sterols, Lavandula Angustifolia (Lavender) Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Borago Officinalis Extract, Centaurea Cyanus Flower Extract, Salvia Sclarea (Clary) Extract, Hyacinthus Orientalis Extract, Camellia Sinensis Leaf Extract, Castanea Crenata (Chestnut) Shell Extract, Zanthoxylum Schinifolium Leaf Extract, Coffea Arabica (Coffee) Seed Extract, Polygonum Cuspidatum Extract, Carthamus Tinctorius (Safflower) Flower Extract, Honey Extract, Eriobotrya Japonica Leaf Extract, Talc, Sucrose, Ceramide NP, Stearic Acid, Polyglutamic Acid, Royal Jelly Extract, Propolis Extract, Oleic Acid, Tocopheryl Acetate, Mineral Salts, sh-Decapeptide-9, Polysorbate 20, Lecithin, Acetyl Hexapeptide-8, Nicotinoyl Tripeptide-1, Nicotinoyl Octapeptide-9, sh-Octapeptide-4, Pentapeptide-37, Decapeptide-12, Caffeoyl Tripeptide-1, sh-Oligopeptide-1, Sh-polypeptide-22, sh-Oligopeptide-2, Sh-polypeptide-5, Sh-polypeptide-60, Sh-polypeptide-2, sh-Polypeptide-4, sh-Polypeptide-11

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

Advanced Ingredient Data

[{"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "1.36", "strengthDenominator": "15", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "1.05", "strengthDenominator": "15", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "0.60", "strengthDenominator": "15", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "Dimethicone", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Dipropylene Glycol", "unii": "E107L85C40", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PURPOSE": "Purpose: Sunscreen", "WARNINGS": "Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep out of reach of children.", "DESCRIPTION": "Uses: Helps prevent sunburn Directions: Take a proper amount of the product and spread it evenly over the entire face.", "ACTIVE INGREDIENT": "Active ingredients: Titanium Dioxide 9.12%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 4.00%", "INACTIVE INGREDIENT": "Inactive Ingredients: Inactive ingredients: Myrothamnus Flabellifolia Callus Culture Extract, Dimethicone, Dipropylene Glycol, Isoamyl p-Methoxycinnamate, Niacinamide, 1,2-Hexanediol, Cetyl PEG/PPG-10/1 Dimethicone, Water, Sodium Chloride, Beeswax, Hydroxyacetophenone, CI 77492, Diisostearyl Malate, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Sorbitan Sesquioleate, CI 77491, Chamomilla Recutita (Matricaria) Flower Extract, Fragrance, Butylene Glycol, Sodium Citrate, Glyceryl Caprylate, CI 77499, Ethylhexylglycerin, Glycerin, Adenosine, Disodium EDTA, Triethoxycaprylylsilane, Macadamia Ternifolia Seed Oil, Hydrogenated Lecithin, Cholesterol, Aluminum Hydroxide, Mica, Polymethyl Methacrylate, Rose Extract, Diospyros Kaki Leaf Extract, Vitis Vinifera (Grape) Fruit Extract, Brassica Campestris (Rapeseed) Sterols, Lavandula Angustifolia (Lavender) Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Borago Officinalis Extract, Centaurea Cyanus Flower Extract, Salvia Sclarea (Clary) Extract, Hyacinthus Orientalis Extract, Camellia Sinensis Leaf Extract, Castanea Crenata (Chestnut) Shell Extract, Zanthoxylum Schinifolium Leaf Extract, Coffea Arabica (Coffee) Seed Extract, Polygonum Cuspidatum Extract, Carthamus Tinctorius (Safflower) Flower Extract, Honey Extract, Eriobotrya Japonica Leaf Extract, Talc, Sucrose, Ceramide NP, Stearic Acid, Polyglutamic Acid, Royal Jelly Extract, Propolis Extract, Oleic Acid, Tocopheryl Acetate, Mineral Salts, sh-Decapeptide-9, Polysorbate 20, Lecithin, Acetyl Hexapeptide-8, Nicotinoyl Tripeptide-1, Nicotinoyl Octapeptide-9, sh-Octapeptide-4, Pentapeptide-37, Decapeptide-12, Caffeoyl Tripeptide-1, sh-Oligopeptide-1, Sh-polypeptide-22, sh-Oligopeptide-2, Sh-polypeptide-5, Sh-polypeptide-60, Sh-polypeptide-2, sh-Polypeptide-4, sh-Polypeptide-11"}