DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Titanium Dioxide (1.15 g) Octinoxate (0.84 g) Zinc Cation (0.58 g) Octisalate (0.54 g)

Inactive Ingredients

Rosa Damascena Flower Oil Butylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2017-03-02

Medication Information

Purpose

Purpose: Sunscreen

Description

Indications & Usage: Apply a thin, even layer using puff.

Dosage & Administration: Take a proper amount of product, and spread it evenly over the entire face..

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 ingredients: Titanium Dioxide 9.59%, ETHYLHEXYL METHOXYCINNAMATE 7.00%, Zinc Oxide 4.90%, ETHYLHEXYL SALICYLATE 4.5%

Inactive Ingredient

Inactive ingredients: Rosa Damascena Flower Water, Cyclopentasiloxane, Butylene Glycol, Cyclohexasiloxane, Cetyl Ethylhexanoate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Water, Mica (CI 77019), Glycerin, Niacinamide, Pentylene Glycol, Phenyl Trimethicone, Silica, Phenoxyethanol, Iron Oxides (CI 77492), Magnesium Sulfate, PEG-10 Dimethicone, Trimethylsiloxysilicate, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Iron Oxides (CI 77491), Fragrance(Parfum), Dimethicone, Ethylhexylglycerin, 1,2-Hexanediol, Iron Oxides (CI 77499), Adenosine, Disodium EDTA, Tocopherol, Copper Tripeptide-1, Acetyl Hexapeptide-8

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)

Indications & Usage: Apply a thin, even layer using puff.

Dosage & Administration: Take a proper amount of product, and spread it evenly over the entire face..

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Titanium Dioxide 9.59%, ETHYLHEXYL METHOXYCINNAMATE 7.00%, Zinc Oxide 4.90%, ETHYLHEXYL SALICYLATE 4.5%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Rosa Damascena Flower Water, Cyclopentasiloxane, Butylene Glycol, Cyclohexasiloxane, Cetyl Ethylhexanoate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Water, Mica (CI 77019), Glycerin, Niacinamide, Pentylene Glycol, Phenyl Trimethicone, Silica, Phenoxyethanol, Iron Oxides (CI 77492), Magnesium Sulfate, PEG-10 Dimethicone, Trimethylsiloxysilicate, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Iron Oxides (CI 77491), Fragrance(Parfum), Dimethicone, Ethylhexylglycerin, 1,2-Hexanediol, Iron Oxides (CI 77499), Adenosine, Disodium EDTA, Tocopherol, Copper Tripeptide-1, Acetyl Hexapeptide-8

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

Advanced Ingredient Data

[{"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "1.15", "strengthDenominator": "12", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "0.84", "strengthDenominator": "12", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ZINC CATION", "unii": "13S1S8SF37", "classCode": "ACTIM", "strengthNumerator": "0.58", "strengthDenominator": "12", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "0.54", "strengthDenominator": "12", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ROSA DAMASCENA FLOWER OIL", "unii": "18920M3T13", "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 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": "Indications & Usage: Apply a thin, even layer using puff. Dosage & Administration: Take a proper amount of product, and spread it evenly over the entire face..", "ACTIVE INGREDIENT": "Active ingredients: Titanium Dioxide 9.59%, ETHYLHEXYL METHOXYCINNAMATE 7.00%, Zinc Oxide 4.90%, ETHYLHEXYL SALICYLATE 4.5%", "INACTIVE INGREDIENT": "Inactive ingredients: Rosa Damascena Flower Water, Cyclopentasiloxane, Butylene Glycol, Cyclohexasiloxane, Cetyl Ethylhexanoate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Water, Mica (CI 77019), Glycerin, Niacinamide, Pentylene Glycol, Phenyl Trimethicone, Silica, Phenoxyethanol, Iron Oxides (CI 77492), Magnesium Sulfate, PEG-10 Dimethicone, Trimethylsiloxysilicate, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Iron Oxides (CI 77491), Fragrance(Parfum), Dimethicone, Ethylhexylglycerin, 1,2-Hexanediol, Iron Oxides (CI 77499), Adenosine, Disodium EDTA, Tocopherol, Copper Tripeptide-1, Acetyl Hexapeptide-8"}