Sunscreen Stick

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (3 g) Zinc Cation (1 g) Octisalate

Inactive Ingredients

Petrolatum Mineral Oil Cocoa Butter Isopropyl Isostearate Hydrogenated Castor Oil Microcrystalline Wax Decyl Olivate 1.alpha.,24s-dihydroxyvitamin D2

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2014-05-08

Medication Information

Purpose

Sunscreen

Description

Octinoxate 3%, Octisalate 3%, Zinc Oxide 1%

Use

• Helps prevent sunburn. • If used as directed with other sun protection

measures (see Directions), decreases the risk of skin cancer and early skin aging

caused by the sun.

Lebel

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.

Directions

• Apply liberally 15 minutes before sun exposure. • Reapply:

• after 80 minutes of swimming or sweating, immediately after towel drying, • at least

every 2 hours. • Sun Protection Measures. Spending time in the sun increases your

risk of skin cancer and early skin aging. To decrease the risk, regularly use a

sunscreen with a broad spectrum SPF of 15 or higher and other sun protection

measures including: • Limit time in sun, especially from 10 a.m. - 2 p.m. • Wear

long-sleeve shirts, pants, hats, and sunglasses. • Children under six months of age:

Ask a doctor.

Active Ingredient

Octinoxate 3%, Octisalate 3%, Zinc Oxide 1%

Inactive Ingredients

Petrolatum, Ozokerite, Mineral Oil, Cocoa Butter, Beeswax,

Isopropyl Isostearate, Hydrogenated Castor Oil, Microcrystalline Wax, Olivate,

Fragrance, Vitamin E.

Keep Out of Reach of Children

Keep out of reach of children. If product is swallowed, get

medical help or contact a Poison Control Center right away.

Structured Label Content

Use

• Helps prevent sunburn. • If used as directed with other sun protection

measures (see Directions), decreases the risk of skin cancer and early skin aging

caused by the sun.

Lebel (lebel)

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.

Directions

• Apply liberally 15 minutes before sun exposure. • Reapply:

• after 80 minutes of swimming or sweating, immediately after towel drying, • at least

every 2 hours. • Sun Protection Measures. Spending time in the sun increases your

risk of skin cancer and early skin aging. To decrease the risk, regularly use a

sunscreen with a broad spectrum SPF of 15 or higher and other sun protection

measures including: • Limit time in sun, especially from 10 a.m. - 2 p.m. • Wear

long-sleeve shirts, pants, hats, and sunglasses. • Children under six months of age:

Ask a doctor.

Active Ingredient

Octinoxate 3%, Octisalate 3%, Zinc Oxide 1%

Inactive Ingredients (Inactive ingredients)

Petrolatum, Ozokerite, Mineral Oil, Cocoa Butter, Beeswax,

Isopropyl Isostearate, Hydrogenated Castor Oil, Microcrystalline Wax, Olivate,

Fragrance, Vitamin E.

Keep Out of Reach of Children (keep out of reach of children)

Keep out of reach of children. If product is swallowed, get

medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ZINC CATION", "unii": "13S1S8SF37", "classCode": "ACTIM", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "Petrolatum", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Mineral oil", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Cocoa butter", "unii": "512OYT1CRR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Isopropyl isostearate", "unii": "C67IXB9Y7T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Hydrogenated castor oil", "unii": "ZF94AP8MEY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Microcrystalline wax", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DECYL OLIVATE", "unii": "AQH29B0B3H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "1.ALPHA.,24S-DIHYDROXYVITAMIN D2", "unii": "2900I92Z36", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "• Helps prevent sunburn. • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.", "Purpose": "Sunscreen", "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.", "Directions": "• Apply liberally 15 minutes before sun exposure. • Reapply: • after 80 minutes of swimming or sweating, immediately after towel drying, • at least every 2 hours. • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeve shirts, pants, hats, and sunglasses. • Children under six months of age: Ask a doctor.", "Active Ingredient": "Octinoxate 3%, Octisalate 3%, Zinc Oxide 1%", "Inactive ingredients": "Petrolatum, Ozokerite, Mineral Oil, Cocoa Butter, Beeswax, Isopropyl Isostearate, Hydrogenated Castor Oil, Microcrystalline Wax, Olivate, Fragrance, Vitamin E.", "keep out of reach of children": "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information