Lip Balm Spf15 Honey Roasted Peanut Flavored

SPL v1

SPL

SPL Set ID 30cc1b72-437b-68ef-e063-6294a90a263f

Route

TOPICAL

Published

Effective Date 2025-03-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Octisalate (0.3 g) Oxybenzone (0.2 g)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-03-20

Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses

Helps prevent sunburn

Section 50565-1

If swallowed, get medical help or

contact a Poison Control Center right away

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

Directions

▪ 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

Drug Facts

Drug Facts

Package Label Pdp

Lip Balm SPF15 Honey Roasted Peanut flavored (NDC 72449-409-01)

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

Sun Protection Measures

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

Stop Use and Ask A Doctor

if rash occurs

Structured Label Content

Uses

Helps prevent sunburn

Section 50565-1 (50565-1)

If swallowed, get medical help or

contact a Poison Control Center right away

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

Directions

▪ 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

Drug Facts

Drug Facts

Package Label Pdp (Package Label PDP)

Lip Balm SPF15 Honey Roasted Peanut flavored (NDC 72449-409-01)

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

Sun Protection Measures

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

Stop Use and Ask A Doctor (Stop Use and Ask a Doctor)

if rash occurs

Advanced Ingredient Data

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

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn", "50565-1": "If swallowed, get medical help or contact a Poison Control Center right away", "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", "Directions": "▪ 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", "Drug Facts": "Drug Facts", "Package Label PDP": "Lip Balm SPF15 Honey Roasted Peanut flavored (NDC 72449-409-01)", "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", "Sun Protection Measures": "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", "Stop Use and Ask a Doctor": "if rash occurs"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:44.842761 · Updated: 2026-03-14T23:08:02.764471