d4563e37-8cfa-4e77-83da-64118f9912c0

Drug Facts

Composition & Product

Active Ingredients

titanium dioxide (4.06 g) octinoxate (3.50 g) zinc cation (2.00 g)

Inactive Ingredients

water phenyl trimethicone

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2017-08-01

Medication Information

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.

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.

Active Ingredient

Active ingredients: Titanium Dioxide 8.12%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 4.00%

Inactive Ingredient

Inactive ingredients: Water, Cyclopentasiloxane, Phenyl Trimethicone, Cyclohexasiloxane, Dimethicone, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Glycerin, Niacinamide, Dicaprylyl Carbonate, Methyl Methacrylate Crosspolymer, Sodium Chloride, Disteardimonium Hectorite, Ozokerite, Trimethylsiloxyphenyl Dimethicone, Hydrogenated Polydecene, Hydrogenated Polyisobutene, Iron Oxides(CI77492), Dimethicone/Vinyl Dimethicone Crosspolymer, Cetyl Peg/Ppg-10/1 Dimethicone, Sorbitan Sesquioleate, Phenoxyethanol, Triethoxycaprylylsilane, Iron Oxides(CI77491), Beeswax, Iron Oxides(CI77499), Aluminum Hydroxide, Ethylhexylglycerin, Fragrance, Adenosine, Silica dimethyl silylate, Disodium EDTA

Package Label.principal Display Panel

Structured Label Content

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.

Purpose (PURPOSE)

Purpose: Sunscreen

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: Titanium Dioxide 8.12%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 4.00%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Cyclopentasiloxane, Phenyl Trimethicone, Cyclohexasiloxane, Dimethicone, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Glycerin, Niacinamide, Dicaprylyl Carbonate, Methyl Methacrylate Crosspolymer, Sodium Chloride, Disteardimonium Hectorite, Ozokerite, Trimethylsiloxyphenyl Dimethicone, Hydrogenated Polydecene, Hydrogenated Polyisobutene, Iron Oxides(CI77492), Dimethicone/Vinyl Dimethicone Crosspolymer, Cetyl Peg/Ppg-10/1 Dimethicone, Sorbitan Sesquioleate, Phenoxyethanol, Triethoxycaprylylsilane, Iron Oxides(CI77491), Beeswax, Iron Oxides(CI77499), Aluminum Hydroxide, Ethylhexylglycerin, Fragrance, Adenosine, Silica dimethyl silylate, Disodium EDTA

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

Advanced Ingredient Data

[{"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "4.06", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "3.50", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ZINC CATION", "unii": "13S1S8SF37", "classCode": "ACTIM", "strengthNumerator": "2.00", "strengthDenominator": "50", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Phenyl Trimethicone", "unii": "DR0K5NOJ4R", "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: Titanium Dioxide 8.12%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 4.00%", "INACTIVE INGREDIENT": "Inactive ingredients: Water, Cyclopentasiloxane, Phenyl Trimethicone, Cyclohexasiloxane, Dimethicone, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Glycerin, Niacinamide, Dicaprylyl Carbonate, Methyl Methacrylate Crosspolymer, Sodium Chloride, Disteardimonium Hectorite, Ozokerite, Trimethylsiloxyphenyl Dimethicone, Hydrogenated Polydecene, Hydrogenated Polyisobutene, Iron Oxides(CI77492), Dimethicone/Vinyl Dimethicone Crosspolymer, Cetyl Peg/Ppg-10/1 Dimethicone, Sorbitan Sesquioleate, Phenoxyethanol, Triethoxycaprylylsilane, Iron Oxides(CI77491), Beeswax, Iron Oxides(CI77499), Aluminum Hydroxide, Ethylhexylglycerin, Fragrance, Adenosine, Silica dimethyl silylate, Disodium EDTA"}