Lip Balm Spf15 Peppermint Flavored

SPL v1

SPL

SPL Set ID 30de9860-03ef-188c-e063-6294a90a314b

Route

TOPICAL

Published

Effective Date 2025-03-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Oxybenzone (0.2 g) Octisalate (0.3 g)

Inactive Ingredients

Beeswax Cetyl Esters Wax Euphorbia Cerifera (candelilla) Wax Petrolatum Cocos Nucifera (coconut) Oil

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-03-21

Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Dosage and Administration

▪ Apply liberally 15 minutes before sun exposure

▪ Reapply at least every 2 hours

▪ Use a water resistant sunscreen if swimming or sweating

▪Children under 6 months of age: Ask a doctor

Description

Drug Facts

Uses

Helps prevent sunburn

Section 42229-5

Spending time in the sun increases your risk

of skin cancer and early skin aging. To decrease this risk, regularly use a

sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun

protection measures including:

▪Limit time in the sun, especially from 10am to 2 pm

▪ Wear long sleeved shirts, pants, hats, and sunglasses

Section 50567-7

keep out of eyes. Rinse with water to remove.

Warnings

For external use only

Do not Use on Damaged or Broken Skin

Drug Facts

Drug Facts

Package Label Pdp

Lip Balm SPF15 Peppermint flavored (NDC 72449-411-01)

Active Ingredients

Oxybenzone 4.7%

Octisalate 7.3%

Inactive Ingredients

Cocos Nucifera (Coconut Oil), Beeswax, Cetyl Esters Wax,

Petrolatum, Cerifera (Candelilla Wax), Flavor.

Questions Or Comments?

Call weekdays from 9AM to 5PM EST

at 631-231-2300

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children

If swallowed, get medical help or

contact a Poison Control Center right away

Structured Label Content

Uses

Helps prevent sunburn

Dosage and Administration (34068-7)

▪ Apply liberally 15 minutes before sun exposure

▪ Reapply at least every 2 hours

▪ Use a water resistant sunscreen if swimming or sweating

▪Children under 6 months of age: Ask a doctor

Section 42229-5 (42229-5)

Spending time in the sun increases your risk

of skin cancer and early skin aging. To decrease this risk, regularly use a

sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun

protection measures including:

▪Limit time in the sun, especially from 10am to 2 pm

▪ Wear long sleeved shirts, pants, hats, and sunglasses

Section 50567-7 (50567-7)

keep out of eyes. Rinse with water to remove.

Purpose

Sunscreen

Warnings

For external use only

Do not Use on Damaged or Broken Skin

Drug Facts

Drug Facts

Package Label Pdp (Package Label PDP)

Lip Balm SPF15 Peppermint flavored (NDC 72449-411-01)

Active Ingredients

Oxybenzone 4.7%

Octisalate 7.3%

Inactive Ingredients

Cocos Nucifera (Coconut Oil), Beeswax, Cetyl Esters Wax,

Petrolatum, Cerifera (Candelilla Wax), Flavor.

Questions Or Comments? (Questions or Comments?)

Call weekdays from 9AM to 5PM EST

at 631-231-2300

Stop Use and Ask A Doctor (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

Advanced Ingredient Data

[{"name": "BEESWAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYL ESTERS WAX", "unii": "D072FFP9GU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OXYBENZONE", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "4.2", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "EUPHORBIA CERIFERA (CANDELILLA) WAX", "unii": "WL0328HX19", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "0.3", "strengthDenominator": "4.2", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "COCOS NUCIFERA (COCONUT) OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn", "34068-7": "▪ Apply liberally 15 minutes before sun exposure ▪ Reapply at least every 2 hours ▪ Use a water resistant sunscreen if swimming or sweating ▪Children under 6 months of age: Ask a doctor", "42229-5": "Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ▪Limit time in the sun, especially from 10am to 2 pm ▪ Wear long sleeved shirts, pants, hats, and sunglasses", "50567-7": "keep out of eyes. Rinse with water to remove.", "Purpose": "Sunscreen", "Warnings": "For external use only Do not Use on Damaged or Broken Skin", "Drug Facts": "Drug Facts", "Package Label PDP": "Lip Balm SPF15 Peppermint flavored (NDC 72449-411-01)", "Active Ingredients": "Oxybenzone 4.7% Octisalate 7.3%", "Inactive Ingredients": "Cocos Nucifera (Coconut Oil), Beeswax, Cetyl Esters Wax, Petrolatum, Cerifera (Candelilla Wax), Flavor.", "Questions or Comments?": "Call weekdays from 9AM to 5PM EST at 631-231-2300", "Stop Use and Ask a Doctor": "if rash occurs", "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: 2026-02-15T12:05:46.010156 · Updated: 2026-03-14T23:08:02.764471