Bs Spf 15 Peppermint Lip Balm

SPL v4

SPL

SPL Set ID 25dcf827-3d06-cad3-e063-6394a90a737d

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

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-11-01

Description

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

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Helps prevent sunburn

Dosage and Administration

Apply liberally 15 minutes before sun exposure

Description

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

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Rash Occurs

Section 50567-7

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

Section 50570-1

on damaged or broken skin.

Section 51727-6

Sunflower Oil*, Beeswax, Olive Oil*, Flavor, Hemp Seed Oil*, Soybean Oil, Sunflower Seed Oil Glycerides, Rosemary Extract, Vitamin E, Aloe Extract, Canola Oil. * Organic

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Section 60562-6

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

Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Rash Occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

on damaged or broken skin.

Section 51727-6 (51727-6)

Sunflower Oil*, Beeswax, Olive Oil*, Flavor, Hemp Seed Oil*, Soybean Oil, Sunflower Seed Oil Glycerides, Rosemary Extract, Vitamin E, Aloe Extract, Canola Oil. * Organic

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Section 60562-6 (60562-6)

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

Advanced Ingredient Data

[{"name": "CANOLA OIL", "unii": "331KBJ17RK", "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": "WHITE WAX", "unii": "7G1J5DA97F", "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"}, {"name": "SOYBEAN OIL", "unii": "241ATL177A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUNFLOWER OIL MONO/DIGLYCERIDES", "unii": "HS7EB0C1ZH", "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", "34071-1": "For external use only", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Rash Occurs", "50567-7": "Keep out of eyes. Rinse well with water to remove.", "50570-1": "on damaged or broken skin.", "51727-6": "Sunflower Oil*, Beeswax, Olive Oil*, Flavor, Hemp Seed Oil*, Soybean Oil, Sunflower Seed Oil Glycerides, Rosemary Extract, Vitamin E, Aloe Extract, Canola Oil. * Organic", "55105-1": "Sunscreen", "55106-9": "Avobenzone 2.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%", "60562-6": "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:12.625074 · Updated: 2026-03-06T01:20:45.603958