DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (3.50 g) Titanium Dioxide (1.69 g) Octisalate (1.50 g) Homosalate

Inactive Ingredients

Water Butylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2017-08-01

Medication Information

Purpose

Purpose: Sunscreen

Description

Uses: - Helps prevent sunburn. - If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Directions: Apply the sun gel liberally to cover all parts of your face and body exposed to the sun's rays.

Warnings

Warnings: For external use only. Avoid contact with eyes. Replace the cap after use. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children.

Active Ingredient

Active ingredients: Ethylhexyl Methoxycinnamate 7.00%, Titanium Dioxide 3.39%, Ethylhexyl Salicylate 3.00%, Homosalate 3.00%

Inactive Ingredient

Inactive ingredients: Water, Butylene Glycol, Cyclopentasiloxane, Niacinamide, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cyclohexasiloxane, Mica (CI 77019), Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Dimethicone, Ethylhexyl Triazone, Glyceryl Stearate, PEG-100 Stearate, Glycol Stearate, Triceteareth-4 Phosphate, Isohexadecane, Polysorbate 80, PEG-2 Stearate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Limnanthes Alba (Meadowfoam) Seed Oil, Potassium Cetyl Phosphate, Biosaccharide Gum-1, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Aluminum Hydroxide, PEG-10 Dimethicone, Stearic Acid, Ethylhexylglycerin, Caprylyl Glycol, Tocopheryl Acetate, Triethoxycaprylylsilane, Allantoin, Adenosine, Disodium EDTA, Xanthan Gum, Sophora Japonica Fruit Extract, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Pancratium Maritimum Extract, Glycerin, Alcohol, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Iron Oxides (CI 77492), Iron Oxides (CI 77491),Fragrance

Package Label.principal Display Panel

Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: For external use only. Avoid contact with eyes. Replace the cap after use. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children.

Description (DESCRIPTION)

Uses: - Helps prevent sunburn. - If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Directions: Apply the sun gel liberally to cover all parts of your face and body exposed to the sun's rays.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Ethylhexyl Methoxycinnamate 7.00%, Titanium Dioxide 3.39%, Ethylhexyl Salicylate 3.00%, Homosalate 3.00%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Butylene Glycol, Cyclopentasiloxane, Niacinamide, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cyclohexasiloxane, Mica (CI 77019), Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Dimethicone, Ethylhexyl Triazone, Glyceryl Stearate, PEG-100 Stearate, Glycol Stearate, Triceteareth-4 Phosphate, Isohexadecane, Polysorbate 80, PEG-2 Stearate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Limnanthes Alba (Meadowfoam) Seed Oil, Potassium Cetyl Phosphate, Biosaccharide Gum-1, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Aluminum Hydroxide, PEG-10 Dimethicone, Stearic Acid, Ethylhexylglycerin, Caprylyl Glycol, Tocopheryl Acetate, Triethoxycaprylylsilane, Allantoin, Adenosine, Disodium EDTA, Xanthan Gum, Sophora Japonica Fruit Extract, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Pancratium Maritimum Extract, Glycerin, Alcohol, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Iron Oxides (CI 77492), Iron Oxides (CI 77491),Fragrance

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

Advanced Ingredient Data

[{"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "3.50", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "1.69", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "1.50", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "1.50", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Butylene Glycol", "unii": "3XUS85K0RA", "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. Replace the cap after use. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children.", "DESCRIPTION": "Uses: - Helps prevent sunburn. - If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun Directions: Apply the sun gel liberally to cover all parts of your face and body exposed to the sun's rays.", "ACTIVE INGREDIENT": "Active ingredients: Ethylhexyl Methoxycinnamate 7.00%, Titanium Dioxide 3.39%, Ethylhexyl Salicylate 3.00%, Homosalate 3.00%", "INACTIVE INGREDIENT": "Inactive ingredients: Water, Butylene Glycol, Cyclopentasiloxane, Niacinamide, Dicaprylyl Carbonate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cyclohexasiloxane, Mica (CI 77019), Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Dimethicone, Ethylhexyl Triazone, Glyceryl Stearate, PEG-100 Stearate, Glycol Stearate, Triceteareth-4 Phosphate, Isohexadecane, Polysorbate 80, PEG-2 Stearate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Limnanthes Alba (Meadowfoam) Seed Oil, Potassium Cetyl Phosphate, Biosaccharide Gum-1, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Aluminum Hydroxide, PEG-10 Dimethicone, Stearic Acid, Ethylhexylglycerin, Caprylyl Glycol, Tocopheryl Acetate, Triethoxycaprylylsilane, Allantoin, Adenosine, Disodium EDTA, Xanthan Gum, Sophora Japonica Fruit Extract, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Pancratium Maritimum Extract, Glycerin, Alcohol, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Iron Oxides (CI 77492), Iron Oxides (CI 77491),Fragrance"}