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
4
Source
full-release
Hydrated at
2026-06-01 00:10:11

Label at a glance#

ProductChapstick Moisturizer Cool Mint
Active ingredientAVOBENZONE, OCTINOXATE, PETROLATUM
Label structure9 sections

Indications and uses

• helps prevent sunburn • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun • 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 • 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...

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%

Octinoxate 7.5%

White petrolatum 41.4%

Purposes

OTC - PURPOSE SECTION

Sunscreens

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • 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

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
  • 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:
    • limited time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

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, artificial flavor, carnauba wax, cetyl alcohol, isocetyl stearate, isopropyl lanolate, lanolin, medium-chain triglycerides, mineral oil, paraffin, saccharin, tocopheryl linoleate/oleate, vitamin E acetate, white wax

Questions or comments?

OTC - QUESTIONS SECTION

call weekdays from 9 AM to 5 PM EST at 1-877-227-3421

Additional information

SPL UNCLASSIFIED SECTION

Marketed by: Pfizer

Madison, NJ 07940 USA

©2018 Pfizer Inc.

For most recent product information, visit www.chapstick.com

Paraben Free

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW
Improved
Formula

BRAND LIP CARE
ChapStick®

SKIN PROTECTANT | SUNSCREEN
BROAD SPECTRUM SPF 15

MOISTURIZER
2 in 1 Lipcare

8 HOUR MOISTURE
SPF 15

Cool Mint

NET WT
0.15 OZ (4 g)

Principal Display Panel - 4 g Cylinder Blister Pack
Principal Display Panel - 4 g Cylinder Blister Pack

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0768-122024-03-21C16284748780-1d6a99b39-6594-a426-e053-dadaa90af4c2Drug Facts
0573-0768-392024-03-21C16284748780-1d6a99b39-6594-a426-e053-dadaa90af4c2Drug Facts
0573-0768-402024-03-21C16284748780-1d6a99b39-6594-a426-e053-dadaa90af4c2Drug Facts
0573-0768-512024-03-21C16284748780-1d6a99b39-6594-a426-e053-dadaa90af4c2Drug Facts
0573-0768-122022-01-28C16284748780-1d6a99b39-6594-a426-e053-dadaa90af4c2Drug Facts
0573-0768-392022-01-28C16284748780-1d6a99b39-6594-a426-e053-dadaa90af4c2Drug Facts
0573-0768-402022-01-28C16284748780-1d6a99b39-6594-a426-e053-dadaa90af4c2Drug Facts
0573-0768-512022-01-28C16284748780-1d6a99b39-6594-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0768-12Chapstick Moisturizer Cool Mint4 g in 1 CYLINDERSTICK44
0573-0768-12Chapstick Moisturizer Cool Mint1 in 1 BLISTER PACKSTICK14
0573-0768-39Chapstick Moisturizer Cool Mint4 g in 1 CYLINDERSTICK44
0573-0768-39Chapstick Moisturizer Cool Mint3 in 1 BLISTER PACKSTICK34
0573-0768-40Chapstick Moisturizer Cool Mint3 in 1 BLISTER PACKSTICK34
0573-0768-40Chapstick Moisturizer Cool Mint4 g in 1 CYLINDERSTICK44
0573-0768-51Chapstick Moisturizer Cool Mint4 g in 1 CYLINDERSTICK44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0768CHAPSTICK MOISTURIZER COOL MINT (AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM) STICK [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 7 package rows20240322_c1120c7a-1fa8-45a4-8bcf-35d9cc9f2c74.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-07680573-0768-12, 0573-0768-39, 0573-0768-40, 0573-0768-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
PETROLATUM4T6H12BN9UACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CARNAUBA WAXR12CBM0EIZIACT
CETYL ALCOHOL936JST6JCNIACT
.ALPHA.-TOCOPHEROL LINOLEATE, D-G0N132Q0EDIACT
ISOCETYL STEARATE3RJ7186O9WIACT
LANOLIN7EV65EAW6HIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
SACCHARINFST467XS7DIACT
.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, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLCc1120c7a-1fa8-45a4-8bcf-35d9cc9f2c742024-03-21WarningsExact identifier
ndc (package): 0573-0768-12
ndc (package): 0573-0768-40
ndc (package): 0573-0768-51
ndc (package): 0573-0768-39
ndc (product): 0573-0768
ndc11 (package): 00573076851
ndc11 (package): 00573076812
ndc11 (package): 00573076839
ndc11 (package): 00573076840
spl id: 4687328b-9343-4115-9a4b-21df2f93419d
spl set id: c1120c7a-1fa8-45a4-8bcf-35d9cc9f2c74

Reported adverse events (FAERS/openFDA)#

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