DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (3.75 g) Octisalate (2.5 g) Titanium Dioxide (1.75 g)

Inactive Ingredients

Butylene Glycol Sorbitan Olivate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2018-07-01

Medication Information

Purpose

Purpose: Sunscreen

Description

Direction: - Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure. Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

Uses: - Helps prevent sunburn - Higher SPF gives more sunburn protection - Retains SPF after 80 minutes of activity in the water or sweating

Warnings

Warnings:

FOR EXTERNAL USE ONLY

- Do not use on damaged or broken skin

- When using this product, Keep out of eyes. Rinse with water to remove.

- Stop use and ask a doctor if rash occurs.

- Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Active Ingredient: ETHYLHEXYL METHOXYCINNAMATE 7.50%, ETHYLHEXYL SALICYLATE 5.00%, TITANIUM DIOXIDE 3.5%

Inactive Ingredient

Inactive Ingredients:

Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Butylene Glycol, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Isoamyl p-Methoxycinnamate, Niacinamide, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Glycerin, Sodium Chloride, Disteardimonium Hectorite, Polyglutamic Acid, Dimethicone Crosspolymer, Aluminum Stearate, Polyhydroxystearic Acid, Alumina, Dimethicone, Dimethiconol, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, 1,2-Hexanediol, Caprylyl Glycol, Dipotassium Glycyrrhizate, Salicornia Herbacea Extract, Phragmites Communis Extract, Adenosine, CI 77492, CI 77491

Package Label.principal Display Panel

Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings:

FOR EXTERNAL USE ONLY

- Do not use on damaged or broken skin

- When using this product, Keep out of eyes. Rinse with water to remove.

- Stop use and ask a doctor if rash occurs.

- Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Description (DESCRIPTION)

Direction: - Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure. Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

Uses: - Helps prevent sunburn - Higher SPF gives more sunburn protection - Retains SPF after 80 minutes of activity in the water or sweating

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: ETHYLHEXYL METHOXYCINNAMATE 7.50%, ETHYLHEXYL SALICYLATE 5.00%, TITANIUM DIOXIDE 3.5%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Butylene Glycol, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Isoamyl p-Methoxycinnamate, Niacinamide, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Glycerin, Sodium Chloride, Disteardimonium Hectorite, Polyglutamic Acid, Dimethicone Crosspolymer, Aluminum Stearate, Polyhydroxystearic Acid, Alumina, Dimethicone, Dimethiconol, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, 1,2-Hexanediol, Caprylyl Glycol, Dipotassium Glycyrrhizate, Salicornia Herbacea Extract, Phragmites Communis Extract, Adenosine, CI 77492, CI 77491

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

Advanced Ingredient Data

[{"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "3.75", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "1.75", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "Butylene Glycol", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sorbitan Olivate", "unii": "MDL271E3GR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PURPOSE": "Purpose: Sunscreen", "WARNINGS": "Warnings: FOR EXTERNAL USE ONLY - Do not use on damaged or broken skin - When using this product, Keep out of eyes. Rinse with water to remove. - Stop use and ask a doctor if rash occurs. - Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.", "DESCRIPTION": "Direction: - Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure. Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection. Uses: - Helps prevent sunburn - Higher SPF gives more sunburn protection - Retains SPF after 80 minutes of activity in the water or sweating", "ACTIVE INGREDIENT": "Active Ingredient: ETHYLHEXYL METHOXYCINNAMATE 7.50%, ETHYLHEXYL SALICYLATE 5.00%, TITANIUM DIOXIDE 3.5%", "INACTIVE INGREDIENT": "Inactive Ingredients: Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Butylene Glycol, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Isoamyl p-Methoxycinnamate, Niacinamide, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Glycerin, Sodium Chloride, Disteardimonium Hectorite, Polyglutamic Acid, Dimethicone Crosspolymer, Aluminum Stearate, Polyhydroxystearic Acid, Alumina, Dimethicone, Dimethiconol, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, 1,2-Hexanediol, Caprylyl Glycol, Dipotassium Glycyrrhizate, Salicornia Herbacea Extract, Phragmites Communis Extract, Adenosine, CI 77492, CI 77491"}