DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (21.3 mg) Titanium Dioxide (26.6 mg)

Inactive Ingredients

Water

Identifiers & Packaging

Pill Appearance

Color: brown

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-03-01

Medication Information

Warnings and Precautions

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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

Indications and Usage

Helps prevent sunburn

Dosage and Administration

Apply liberally 15 minutes before sun exposure

Children under 6 months of age: Ask a doctor

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Description

Water (Aqua), Isohexadecane, Butylene Glycol, Isononyl Isononanoate, Phenyl Trimethicone, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Ethylhexyl Stearate, PEG-10 Dimethicone, Sodium Hydroxide, Quaternium-18 Bentonite, Phenoxyethanol, Hydroxyacetophenone, Rosa Damascena Flower Water, Glycerin, C20-40 Alcohols, Alumina, Stearic Acid, Behenyl Behenate, Copernicia Cerifera (Carnauba) Wax, Glycol Distearate, Triethoxycaprylylsilane, Tocopheryl Acetate, Aluminum Hydroxide, Montan Acid Wax, Cucumis Sativus (Cucumber) Fruit Extract, Sodium Hyaluronate, Chondrus Crispus Extract, Potassium Sorbate, Sodium Benzoate, Iron Oxides (CI 77491, 77492, 77499).

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a poison control right away.

Section 51727-6

Water (Aqua), Isohexadecane, Butylene Glycol, Isononyl Isononanoate, Phenyl Trimethicone, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Ethylhexyl Stearate, PEG-10 Dimethicone, Sodium Hydroxide, Quaternium-18 Bentonite, Phenoxyethanol, Hydroxyacetophenone, Rosa Damascena Flower Water, Glycerin, C20-40 Alcohols, Alumina, Stearic Acid, Behenyl Behenate, Copernicia Cerifera (Carnauba) Wax, Glycol Distearate, Triethoxycaprylylsilane, Tocopheryl Acetate, Aluminum Hydroxide, Montan Acid Wax, Cucumis Sativus (Cucumber) Fruit Extract, Sodium Hyaluronate, Chondrus Crispus Extract, Potassium Sorbate, Sodium Benzoate, Iron Oxides (CI 77491, 77492, 77499).

Section 51945-4

Section 55105-1

helps prevent sunburn

Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure

Children under 6 months of age: Ask a doctor

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Warnings and Precautions (34071-1)

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a poison control right away.

Section 51727-6 (51727-6)

Water (Aqua), Isohexadecane, Butylene Glycol, Isononyl Isononanoate, Phenyl Trimethicone, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Ethylhexyl Stearate, PEG-10 Dimethicone, Sodium Hydroxide, Quaternium-18 Bentonite, Phenoxyethanol, Hydroxyacetophenone, Rosa Damascena Flower Water, Glycerin, C20-40 Alcohols, Alumina, Stearic Acid, Behenyl Behenate, Copernicia Cerifera (Carnauba) Wax, Glycol Distearate, Triethoxycaprylylsilane, Tocopheryl Acetate, Aluminum Hydroxide, Montan Acid Wax, Cucumis Sativus (Cucumber) Fruit Extract, Sodium Hyaluronate, Chondrus Crispus Extract, Potassium Sorbate, Sodium Benzoate, Iron Oxides (CI 77491, 77492, 77499).

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

helps prevent sunburn

Advanced Ingredient Data

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"TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "26.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "21.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "21.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "26.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "21.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "26.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "21.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "26.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "26.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "21.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "21.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "26.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "21.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "26.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Helps prevent sunburn", "34068-7": "Apply liberally 15 minutes before sun exposure Children under 6 months of age: Ask a doctor Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating", "34071-1": "Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. 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", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a poison control right away.", "51727-6": "Water (Aqua), Isohexadecane, Butylene Glycol, Isononyl Isononanoate, Phenyl Trimethicone, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Ethylhexyl Stearate, PEG-10 Dimethicone, Sodium Hydroxide, Quaternium-18 Bentonite, Phenoxyethanol, Hydroxyacetophenone, Rosa Damascena Flower Water, Glycerin, C20-40 Alcohols, Alumina, Stearic Acid, Behenyl Behenate, Copernicia Cerifera (Carnauba) Wax, Glycol Distearate, Triethoxycaprylylsilane, Tocopheryl Acetate, Aluminum Hydroxide, Montan Acid Wax, Cucumis Sativus (Cucumber) Fruit Extract, Sodium Hyaluronate, Chondrus Crispus Extract, Potassium Sorbate, Sodium Benzoate, Iron Oxides (CI 77491, 77492, 77499).", "55105-1": "helps prevent sunburn"}