bs spf 15 beeswax lip balm

SPL v5

SPL

SPL Set ID 2dcc2f9b-4a8c-b281-e063-6294a90ad9d6

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 soybean oil white wax sunflower oil tocopherol rosemary olive oil cannabis sativa seed oil aloe vera leaf

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph drug active Since 2020-02-17

Purpose

Sunscreen

Description

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

Medication Information

Warnings

For external use only

Indications and Usage

Helps prevent sunburn

Purpose

Sunscreen

Dosage and Administration

Apply liberally 15 mintues before sun exposure

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

Description

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

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, Hemp Seed Oil*, Rosemary Extract, Aloe Extract, Soybean Oil, Canola 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

Warnings

For external use only

Indications and Usage (34067-9)

Helps prevent sunburn

Purpose

Sunscreen

Dosage and Administration (34068-7)

Apply liberally 15 mintues before sun exposure

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, Hemp Seed Oil*, Rosemary Extract, Aloe Extract, Soybean Oil, Canola 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

[{"name": "SUNFLOWER OIL MONO/DIGLYCERIDES", "unii": "HS7EB0C1ZH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CANOLA OIL", "unii": "331KBJ17RK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SOYBEAN OIL", "unii": "241ATL177A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE WAX", "unii": "7G1J5DA97F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUNFLOWER OIL", "unii": "3W1JG795YI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ROSEMARY", "unii": "IJ67X351P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OLIVE OIL", "unii": "6UYK2W1W1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CANNABIS SATIVA SEED OIL", "unii": "69VJ1LPN1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "0.21", "strengthDenominator": "4.25", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "0.09", "strengthDenominator": "4.25", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "0.06", "strengthDenominator": "4.25", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "0.28", "strengthDenominator": "4.25", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Helps prevent sunburn", "34068-7": "Apply liberally 15 mintues 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, Hemp Seed Oil*, Rosemary Extract, Aloe Extract, Soybean Oil, Canola 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: 2026-02-15T12:05:31.513011 · Updated: 2026-03-14T23:07:26.290118