FDA.reportPublic FDA data

Chapstick Moisturizer Cool Mint

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:10:08

Label at a glance#

ProductChapstick Moisturizer Cool Mint
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, PETROLATUM
Label structure9 sections

Indications and uses

• helps prevent sunburn • helps prevent and temporarily protects chafed, chapped or cracked lips • helps prevent and protect from the drying effects of wind and cold weather

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

Storage and handling

• store at 20-25°C (68-77°F) • protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 4.0%

Octisalate 4.5%

Octocrylene 2.6%

White Petrolatum 36.9%

Purposes

OTC - PURPOSE SECTION

Sunscreens

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • helps prevent and temporarily protects chafed, chapped or cracked lips
  • helps prevent and protect from the drying effects of wind and cold weather

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 damaged or broken skin

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - WHEN USING SECTION

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

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 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, benzyl alcohol, BHT, cetyl alcohol, copernicia cerifera (carnauba) wax, flavor, isocetyl stearate, isopropyl lanolate, lanolin, mineral oil, myristyl alcohol, paraffin, stearyl alcohol, tocopherol, tocopheryl acetate, tocopheryl linoleate/oleate, white beeswax

Questions or comments?

OTC - QUESTIONS SECTION

call weekdays from 9 AM to 6 PM EST at

1-800-245-1040

Additional information

SPL UNCLASSIFIED SECTION

Paraben Free

Dist by: GSK CH, Warren, NJ 07059

For most recent product information,

visit www.chapstick.com

Trademarks owned or licensed by GSK.

©2022 GSK or licensor

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW Formula
BRAND LIP CARE
ChapStick®

SKIN PROTECTANT | SUNSCREEN
SPF 12

MOISTURIZER
2 in 1 Lipcare Cool Mint

8 HOUR MOISTURE
SPF 12

3 STICKS

NET WT 0.15 OZ

(4 g) EACH

000073771

000073771 Chapstick Moisturizer CM 0.15 oz(4 g)
000073771 Chapstick Moisturizer CM 0.15 oz(4 g)

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-1957-01Chapstick Moisturizer Cool Mint4 g in 1 CYLINDERSTICK42
0573-1957-01Chapstick Moisturizer Cool Mint3 in 1 BLISTER PACKSTICK32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-1957CHAPSTICK MOISTURIZER COOL MINT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM) STICK [HALEON US HOLDINGS LLC]2Current NDC, Legacy NDC, 2 package rows20240322_33497c07-ad6e-4c50-bc23-a55725b2eae1.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-19570573-1957-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
PETROLATUM4T6H12BN9UACTIB
ALOE VERA LEAFZY81Z83H0XIACT
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETYL ALCOHOL936JST6JCNIACT
CARNAUBA WAXR12CBM0EIZIACT
ISOCETYL STEARATE3RJ7186O9WIACT
LANOLIN7EV65EAW6HIACT
MINERAL OILT5L8T28FGPIACT
MYRISTYL ALCOHOLV42034O9PUIACT
PARAFFINI9O0E3H2ZEIACT
STEARYL ALCOHOL2KR89I4H1YIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WHITE WAX7G1J5DA97FIACT

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
Chapstick Moisturizer Cool MintAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLC33497c07-ad6e-4c50-bc23-a55725b2eae12024-03-21WarningsExact identifier
ndc (package): 0573-1957-01
ndc (product): 0573-1957
ndc11 (package): 00573195701
spl id: 017ba856-da3d-4306-b156-be341a93fe75
spl set id: 33497c07-ad6e-4c50-bc23-a55725b2eae1

Reported adverse events (FAERS/openFDA)#

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