Broad Spectrum Spf 15 Spearmint Lip Balm

SPL v3

SPL

SPL Set ID a9029e6d-7443-efe2-e053-2995a90a8125

Route

TOPICAL

Published

Effective Date 2020-02-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Octisalate (0.21 g) Avobenzone (0.09 g) Octocrylene (0.06 g) Octinoxate (0.28 g)

Inactive Ingredients

Sunflower Oil Mono/diglycerides Canola Oil Sunflower Oil Tocopherol Rosemary White Wax Olive Oil Cannabis Sativa Seed Oil Aloe Vera Leaf Soybean Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-02-17

Description

Avobenzone 2.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%

Purpose

Sunscreen

Medication Information

Indications and Usage

Helps prevent sunburn

Purpose

Sunscreen

Dosage and Administration

Apply liberally 15 minutes before exposure

Description

Avobenzone 2.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%

Warnings

For external use only

Directions

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Children under 6 months of age: Ask a doctor

Do Not Use

on damaged or broken skin.

Package Label

Active Ingredients

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Inactive Ingredients:

Sunflower oil*, Beeswax, Olive Oil*, Flavor, Hemp Seed Oil*, Rosemary Extract, Tocopherol, Aloe Extract, Soybean Oil, Sunflower Seed Oil Glycerides. * Organic

When Using This Product

Keep out of eyes. Rinse well with water to remove.

Stop Use and Ask A Doctor If

Rash Occurs

Keep Out of Reach of Children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

Apply liberally 15 minutes before exposure

Purpose

Sunscreen

Warnings

For external use only

Directions

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Children under 6 months of age: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin.

Package Label

Active Ingredients

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Inactive Ingredients: (Inactive ingredients:)

Sunflower oil*, Beeswax, Olive Oil*, Flavor, Hemp Seed Oil*, Rosemary Extract, Tocopherol, Aloe Extract, Soybean Oil, Sunflower Seed Oil Glycerides. * Organic

When Using This Product (When Using this Product)

Keep out of eyes. Rinse well with water to remove.

Stop Use and Ask A Doctor If (Stop Use and ask a doctor if)

Rash Occurs

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Helps prevent sunburn", "34068-7": "Apply liberally 15 minutes before exposure", "Purpose": "Sunscreen", "Warnings": "For external use only", "Directions": "Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months of age: Ask a doctor", "Do not use": "on damaged or broken skin.", "Active Ingredients": "Avobenzone 2.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%", "Inactive ingredients:": "Sunflower oil*, Beeswax, Olive Oil*, Flavor, Hemp Seed Oil*, Rosemary Extract, Tocopherol, Aloe Extract, Soybean Oil, Sunflower Seed Oil Glycerides. * Organic", "When Using this Product": "Keep out of eyes. Rinse well with water to remove.", "Stop Use and ask a doctor if": "Rash Occurs", "Keep out of reach of children": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:25.989624 · Updated: 2026-03-14T23:01:25.991637