82723-001 - DailyMed Details

82723-001

SPL v4

SPL

SPL Set ID de66edea-b435-a9df-e053-2995a90a4205

Route

topical

Published

Effective Date 2022-05-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

octocrylene (3 g) avobenzone (5 g) octisalate (8 g) homosalate

Inactive Ingredients

eucalyptus globulus leaf sunflower oil alcohol cyclomethicone 6 melaleuca alternifolia leaf ethylhexyl palmitate alpha-tocopherol hyaluronic acid peppermint cyclomethicone 5 niacinamide ascorbic acid

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2022-05-07

Purpose

Sunscreen

Description

Homosalate 8.0% Octisalate 5.0% Octocrylene 3.0% Avobenzone 3.0%

Medication Information

Warnings

For External Use Only.

Do not use on damaged or broken skin.

Keep out of reach of children.

Keep out of eyes. Rinse with water to remove.

Stop use and ask a physician if rash occurs.

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

Uses

Helps prevent sunburn. If used as directed with other sun protection measures, decrease the risk of skin cancer and early skin aging caused by sun.

Purpose

Sunscreen

Directions

•Apply to face 15 minutes before sun exposure.

Reapply every 2 hours.

Other Information

Children under 6 months ask a physician.

Inactive Ingredients

Vitamin E, Vitamin C, Hyaluronic Acid, Niacinamide, Peppermint Extract, Eucalyptus Extract, Sunflower Seed Oil, Tea Tree Extract, Alcohol, Cyclohexasiloxane, Cyclopentasiloxane, Ethylhexyl Palmitate

Description

Homosalate 8.0% Octisalate 5.0% Octocrylene 3.0% Avobenzone 3.0%

Section 50567-7

For External Use Only.

Do not use on damaged or broken skin.

Keep out of reach of children.

Keep out of eyes. Rinse with water to remove.

Stop use and ask a physician if rash occurs.

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

Stop Use

Stop use and ask a physician if rash occurs.

Do Not Use

Do not use on damaged or broken skin.

Package Label

Active Ingredients

Homosalate 8.0%

Octisalate 5.0%

Octocrylene 3.0%

Avobenzone 3.0%

Keep Out of Reach of Children.

Keep out of reach of children.

Structured Label Content

Warnings

For External Use Only.

Do not use on damaged or broken skin.

Keep out of reach of children.

Keep out of eyes. Rinse with water to remove.

Stop use and ask a physician if rash occurs.

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

Uses

Helps prevent sunburn. If used as directed with other sun protection measures, decrease the risk of skin cancer and early skin aging caused by sun.

Purpose

Sunscreen

Directions

•Apply to face 15 minutes before sun exposure.

Reapply every 2 hours.

Other Information

Children under 6 months ask a physician.

Inactive Ingredients

Vitamin E, Vitamin C, Hyaluronic Acid, Niacinamide, Peppermint Extract, Eucalyptus Extract, Sunflower Seed Oil, Tea Tree Extract, Alcohol, Cyclohexasiloxane, Cyclopentasiloxane, Ethylhexyl Palmitate

Section 50567-7 (50567-7)

For External Use Only.

Do not use on damaged or broken skin.

Keep out of reach of children.

Keep out of eyes. Rinse with water to remove.

Stop use and ask a physician if rash occurs.

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

Stop Use (Stop use)

Stop use and ask a physician if rash occurs.

Do Not Use (Do not use)

Do not use on damaged or broken skin.

Package Label

Active Ingredients

Homosalate 8.0%

Octisalate 5.0%

Octocrylene 3.0%

Avobenzone 3.0%

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

Keep out of reach of children.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn. If used as directed with other sun protection measures, decrease the risk of skin cancer and early skin aging caused by sun.", "50567-7": "For External Use Only. Do not use on damaged or broken skin. Keep out of reach of children. Keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center immediately.", "Purpose": "Sunscreen", "Stop use": "Stop use and ask a physician if rash occurs.", "Warnings": "For External Use Only. Do not use on damaged or broken skin. Keep out of reach of children. Keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center immediately.", "Directions": "•Apply to face 15 minutes before sun exposure. Reapply every 2 hours.", "Do not use": "Do not use on damaged or broken skin.", "Other Information": "Children under 6 months ask a physician.", "Active Ingredients": "Homosalate 8.0% Octisalate 5.0% Octocrylene 3.0% Avobenzone 3.0%", "Inactive Ingredients": "Vitamin E, Vitamin C, Hyaluronic Acid, Niacinamide, Peppermint Extract, Eucalyptus Extract, Sunflower Seed Oil, Tea Tree Extract, Alcohol, Cyclohexasiloxane, Cyclopentasiloxane, Ethylhexyl Palmitate", "Keep out of reach of children.": "Keep out of reach of children."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:17.141521 · Updated: 2026-03-14T23:06:51.816479