Lip Balm Spf15 Unflavored

Lip Balm Spf15 Unflavored
SPL v3
SPL
SPL Set ID 3131632d-735c-6688-e063-6294a90a0239
Route
TOPICAL
Published
Effective Date 2025-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Octocrylene (3 g) Octisalate (5 g) Homosalate
Inactive Ingredients
Olea Europaea (olive) Fruit Oil Butyrospermum Parkii (shea) Butter Synthetic Wax (1800 Mw) Bht Beeswax Phenoxyethanol Polyisobutylene (1000 Mw) Ceresin Mineral Oil Ethylhexyl Palmitate Cocos Nucifera (coconut) Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-25
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses

Helps prevent sunburn

Section 51727-6

Mineral oil, beeswax, ethylhexyl palmitate,

ozokerite, cocos nucifera (coconut) oil, olea europaea (olive) fruit oil,

polyisobutene, butyrospermum parkii (shea) butter, synthetic wax,

phenoxyethanol, BHT

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 Unflavored (NDC 72449-301-01)

Active Ingredients

Octocrylene 3%

Homosalate 5%

Avobenzone 2%

Octisalate 3%

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

When Using This Product

keep out of eyes. Rinse with water to remove.

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

Section 51727-6 (51727-6)

Mineral oil, beeswax, ethylhexyl palmitate,

ozokerite, cocos nucifera (coconut) oil, olea europaea (olive) fruit oil,

polyisobutene, butyrospermum parkii (shea) butter, synthetic wax,

phenoxyethanol, BHT

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 Unflavored (NDC 72449-301-01)

Active Ingredients

Octocrylene 3%

Homosalate 5%

Avobenzone 2%

Octisalate 3%

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

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:47.645694 · Updated: 2026-03-14T23:08:06.304944