FDA.reportPublic FDA data

Chapstick Moisturizer Original

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:10:13

Label at a glance#

ProductChapstick Moisturizer Original
Active ingredientAVOBENZONE, OCTINOXATE, PETROLATUM
Label structure8 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 the 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 42.3%

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:
    • Limit 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 the product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, carnauba wax, cetyl alcohol, fragrance, isocetyl stearate, isopropyl lanolate, lanolin, mineral oil, paraffin, saccharin, tocopheryl linoleate/oleate, vitamin E acetate, white wax

Questions or comments?

OTC - QUESTIONS SECTION

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

Additional information

SPL UNCLASSIFIED SECTION

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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

Trademarks are owned by or licensed to the

GSK group of companies.

©2023 GSK or licensor.

Paraben Free

Moisturizer Original

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

Original

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
0573-0725-122023-03-22C16284748780-1d6a99b39-7f52-a426-e053-dadaa90af4c2Drug Facts
0573-0725-302023-03-22C16284748780-1d6a99b39-7f52-a426-e053-dadaa90af4c2Drug Facts
0573-0725-402023-03-22C16284748780-1d6a99b39-7f52-a426-e053-dadaa90af4c2Drug Facts
0573-0725-512023-03-22C16284748780-1d6a99b39-7f52-a426-e053-dadaa90af4c2Drug Facts
0573-0725-122022-01-28C16284748780-1d6a99b39-7f52-a426-e053-dadaa90af4c2Drug Facts
0573-0725-302022-01-28C16284748780-1d6a99b39-7f52-a426-e053-dadaa90af4c2Drug Facts
0573-0725-402022-01-28C16284748780-1d6a99b39-7f52-a426-e053-dadaa90af4c2Drug Facts
0573-0725-512022-01-28C16284748780-1d6a99b39-7f52-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0725-12Chapstick Moisturizer Original1 in 1 BLISTER PACKSTICK15
0573-0725-12Chapstick Moisturizer Original4 g in 1 CYLINDERSTICK45
0573-0725-14Chapstick Moisturizer Original2 in 1 BLISTER PACKSTICK25
0573-0725-14Chapstick Moisturizer Original4 g in 1 CYLINDERSTICK45
0573-0725-30Chapstick Moisturizer Original4 g in 1 CYLINDERSTICK45
0573-0725-30Chapstick Moisturizer Original3 in 1 BLISTER PACKSTICK35
0573-0725-40Chapstick Moisturizer Original4 g in 1 CYLINDERSTICK45
0573-0725-40Chapstick Moisturizer Original3 in 1 BLISTER PACKSTICK35
0573-0725-51Chapstick Moisturizer Original4 g in 1 CYLINDERSTICK45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0725CHAPSTICK MOISTURIZER ORIGINAL (AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM) STICK [HALEON US HOLDINGS LLC]5Current NDC, Legacy NDC, 9 package rows20240324_9cd13fbb-887f-46a8-9f0b-4450ad3e07b7.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-07250573-0725-12, 0573-0725-30, 0573-0725-40, 0573-0725-51, 0573-0725-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChapstickAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC0e34fc74-772e-48fd-a353-58807ef412c12024-05-01WarningsExact identifier
ndc (package): 0573-0725-12
ndc11 (package): 00573072512
Chapstick Moisturizer OriginalAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC9cd13fbb-887f-46a8-9f0b-4450ad3e07b72024-03-22WarningsExact identifier
ndc (package): 0573-0725-14
ndc (package): 0573-0725-12
ndc (package): 0573-0725-40
ndc (package): 0573-0725-30
ndc (package): 0573-0725-51
ndc (product): 0573-0725
ndc11 (package): 00573072551
ndc11 (package): 00573072540
ndc11 (package): 00573072530
ndc11 (package): 00573072512
ndc11 (package): 00573072514
spl id: 779fb329-9bd6-44ed-ae2d-305caa1e765b
spl set id: 9cd13fbb-887f-46a8-9f0b-4450ad3e07b7

Reported adverse events (FAERS/openFDA)#

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