DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (7 g) Ensulizole (2 g) Octisalate (4.5 g)

Inactive Ingredients

Water Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2018-08-13

Medication Information

Warnings and Precautions

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

1) Occurrence of red spots, swelling, itchiness, and other irritation

2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other irritations

3. Precaution for Storage and Handling

1) Close the lid after use

2) Keep out of reach of infants and children

3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

Indications and Usage

Apply liberally 15 minutes before sun exposure

Dosage and Administration

external use only

Description

octinoxate, octisalate, ensulizole

Section 50565-1

Keep out of reach of children.

Section 51727-6

water, glycerin, dipropylene glycol, etc.

Section 51945-4

Section 55105-1

helps prevent sunburn

Section 55106-9

octinoxate, octisalate, ensulizole

Structured Label Content

Indications and Usage (34067-9)

Apply liberally 15 minutes before sun exposure

Dosage and Administration (34068-7)

external use only

Warnings and Precautions (34071-1)

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

1) Occurrence of red spots, swelling, itchiness, and other irritation

2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other irritations

3. Precaution for Storage and Handling

1) Close the lid after use

2) Keep out of reach of infants and children

3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

water, glycerin, dipropylene glycol, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

helps prevent sunburn

Section 55106-9 (55106-9)

octinoxate, octisalate, ensulizole

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "7", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ENSULIZOLE", "unii": "9YQ9DI1W42", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "4.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Apply liberally 15 minutes before sun exposure", "34068-7": "external use only", "34071-1": "1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms). 1) Occurrence of red spots, swelling, itchiness, and other irritation 2) If the symptoms above occur after the application area is exposed to direct sunlight 2. Do not use on open wounds, eczema, and other irritations 3. Precaution for Storage and Handling 1) Close the lid after use 2) Keep out of reach of infants and children 3) Do not to store in a place with high/low temperature and exposed to direct sunlight 4. Use as avoiding eye areas.", "50565-1": "Keep out of reach of children.", "51727-6": "water, glycerin, dipropylene glycol, etc.", "55105-1": "helps prevent sunburn", "55106-9": "octinoxate, octisalate, ensulizole"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information