FDA.reportPublic FDA data

MEDICATED LIP BALM

Manufacturer
Xtreme Tools International, Inc
Effective date
2024-12-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:43:55

Label at a glance#

ProductMEDICATED LIP BALM
Active ingredientDIMETHICONE, OXYBENZONE, PADIMATE O
Label structure13 sections

Indications and uses

Temporarily protects and relieve chapped or cracked lips Helps prevent sunburn

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 years of age: Ask a doctor

Storage and handling

protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 2.0%

Oxybenzone 2.5%

2-Ethylhexyl Dimethyl PABA 6.6%

Purpose

OTC - PURPOSE SECTION

Dimethicone 2.0% - Lip protectant

Oxybenzone 2.5%- Sunscreen

2-Ethylhexyl Dimethyl PABA 6.6%- Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects and relieve chapped or cracked lips
  • Helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

OTC - DO NOT USE SECTION

Do not use on broken or damaged skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 years of age: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Prunus Arnygdalus Dulcis (Sweet Almond) Oil, Anthemis Nobilis Flower Extract, Hydrogenated Vegetable Oil, Beeswax, Shea Butter Ethyl Esters, Cocos Nucifera (Coconut) Oil, Argania Spinosa (Argan) Nut Oil, Tocopheryl Acetate, Organic flavors.

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-305-622-7474 Monday through Friday 9:00 AM to 5:00 PM

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5 gram in Jar ; NDC 74553-004-01

LIPBALMLIPBALM

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74553-00474553-004-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALMOND OIL66YXD4DKO9IACT
CHAMAEMELUM NOBILE FLOWERO2T154T6OGIACT
YELLOW WAX2ZA36H0S2VIACT
DIMETHICONE92RU3N3Y1OACTIB
COCONUT OILQ9L0O73W7LIACT
ARGAN OIL4V59G5UW9XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SHEA BUTTER ETHYL ESTERSV2CI786FPGIACT
OXYBENZONE95OOS7VE0YACTIB
PADIMATE OZ11006CMUZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
340ce4a9-9388-47c9-ac3e-236b320ba326b139e34b-4fe8-41d9-e053-2a95a90aaa5a2025-03-12WarningsExact identifier
spl set id: b139e34b-4fe8-41d9-e053-2a95a90aaa5a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.