Bs Spf 15 Caribbean Breeze Lip Balm

SPL v3

SPL

SPL Set ID a75a42f6-27d1-e2cc-e053-2a95a90aa6da

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

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 sun 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*, Soybean Oil, Sunflower Seed Oil Glycerides, Rosemary Extract, Vitamin E, Aloe Extract, Canola Oil. * 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 sun 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*, Soybean Oil, Sunflower Seed Oil Glycerides, Rosemary Extract, Vitamin E, Aloe Extract, Canola Oil. * 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 sun 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*, Soybean Oil, Sunflower Seed Oil Glycerides, Rosemary Extract, Vitamin E, Aloe Extract, Canola Oil. * 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: 2026-02-15T12:01:42.553654 · Updated: 2026-03-14T23:01:28.904310