Spf 15 Mineral Lip Balm

SPL v30

SPL

SPL Set ID 44d2759a-d95d-7525-e054-00144ff88e88

Route

TOPICAL

Published

Effective Date 2020-02-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (0.34 g)

Inactive Ingredients

Canola Oil Sunflower Oil Tocopherol White Wax Olive Oil Aloe Vera Leaf Soybean Oil

Identifiers & Packaging

Pill Appearance

Color: white

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*, Tocopherol, Aloe Extract, Canola Oil, Soybean 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*, Tocopherol, Aloe Extract, Canola Oil, Soybean 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

[{"name": "CANOLA OIL", "unii": "331KBJ17RK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "0.34", "strengthDenominator": "4.25", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SUNFLOWER OIL", "unii": "3W1JG795YI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE WAX", "unii": "7G1J5DA97F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OLIVE OIL", "unii": "6UYK2W1W1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SOYBEAN OIL", "unii": "241ATL177A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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*, Tocopherol, Aloe Extract, Canola Oil, Soybean 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: 2026-02-15T12:01:25.981576 · Updated: 2026-03-14T23:01:25.991637