FDA.reportPublic FDA data

Chapstick

Manufacturer
Haleon US Holdings LLC
Effective date
2024-05-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:11:51

Label at a glance#

ProductChapstick
Active ingredientAVOBENZONE, OCTINOXATE, PETROLATUM
Label structure6 sections

Label contents#

Full prescribing information#

Moisturizer 2 in 1 Lip Care | Original

SPL UNCLASSIFIED SECTION

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 useon damaged or broken skin

OTC - STOP USE SECTION

Stop use and ask a doctor ifrash occurs

OTC - WHEN USING SECTION

When using this productkeep 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, 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 9 AM to 5 PM EST at 1-877-227-3421

Classic | Original . Cherry . Strawberry

SPL UNCLASSIFIED SECTION

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

White petrolatum 45%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • 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

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed

Other Information

STORAGE AND HANDLING SECTION

store at 20-25°C (68-77°F)

Inactive ingredients (Original)

INACTIVE INGREDIENT SECTION

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, red 6 lake, titanium, white wax, yellow 5 lake

Inactive ingredients (Cherry)

INACTIVE INGREDIENT SECTION

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, menthol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax

Inactive ingredients (Strawberry)

INACTIVE INGREDIENT SECTION

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, lemon oil, light mineral oil, maltol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax

Chapstick total hydration Eucalyptus Mint

SPL UNCLASSIFIED SECTION

Ingredients:

SPL UNCLASSIFIED SECTION

helianthus annuus (sunflower) seed oil, jojoba esters, euphorbia cerifera (candelilla) wax, cocos nucifera (coconut) oil, beeswax, caprylic/capric triglyceride, copernicia cerifera (carnauba) wax,

argania spinosa (argan) kernel oil, flavor, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, mangifera indica (mango) seed butter, butyrospermum parkii (shea) butter, octyldodecanol, persea gratissima (avocado) oil, olea europaea (olive) fruit oil, tocopherol, hydrogenated soybean oil, aloe barbadensis leaf extract, rubus idaeus (raspberry) seed oil, glyceryl stearate

Other information

SPL UNCLASSIFIED SECTION

store at 20-25°C (68-77°F).

Chapstick total hydration Soothing Vanilla

SPL UNCLASSIFIED SECTION

Ingredients:

SPL UNCLASSIFIED SECTION

helianthus annuus (sunflower) seed oil, jojoba esters, euphorbia cerifera (candelilla) wax, cocos nucifera (coconut) oil, beeswax, caprylic/capric triglyceride, copernicia cerifera (carnauba) wax,

argania spinosa (argan) kernel oil, flavor, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, mangifera indica (mango) seed butter, butyrospermum parkii (shea) butter, octyldodecanol, persea gratissima (avocado) oil, olea europaea (olive) fruit oil, tocopherol, hydrogenated soybean oil, aloe barbadensis leaf extract, rubus idaeus (raspberry) seed oil, glyceryl stearate

Other information

SPL UNCLASSIFIED SECTION

store at 20-25°C (68-77°F).

Additional Information

SPL UNCLASSIFIED SECTION

Paraben Free . Cruelty Free

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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

Trademarks owned or licensed by GSK ©2021 GSK or licensor

Patents: www.productspats.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0573-2027-01

ChapStick ®

PUT YOUR LIPS FIRST®

1 EUCALYPTUS MINT

1 SOOTHING VANILLA

  • *100% naturally sourced ingredients
  • Age defying formula with argan oil and avocado butters
  • Contains omegas 6 & 9

2 MOISTURIZER ORIGINAL
SKIN PROTECTANT / SUNSCREEN
BROAD SPECTRUM SPF 15

SPF 15

2 CLASSIC STRAWBERRY
SKIN PROTECTANT

3 CLASSIC CHERRY
SKIN PROTECTANT

Paraben Free

Cruelty Free

3 CLASSIC ORIGINAL
SKIN PROTECTANT

12 INDIVIDUAL STICKS
TOTAL HYDRATION

-2 STICKS
NET WT 0.12 OZ
(3.5g) EACH

MOISTURIZER
-2 STICKS
NET WT 0.15 OZ
(4g) EACH

CLASSIC
-8 STICKS
NET WT 0.15 OZ
(4g) EACH

PAA166168 – Front

PAA166168 Chapstick 12 Individual Sticks
PAA166168 Chapstick 12 Individual Sticks

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-2027-012023-02-04C16284748780-1f386c649-d476-0266-e053-dadaa90a7c1aDrug Facts
0573-2027-012023-01-30C16284748780-1f386c649-d476-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0701-12Chapstick1 in 1 BLISTER PACKSTICK450 mg in 1g3
0573-0701-12Chapstick4 g in 1 CYLINDERSTICK12 g450 mg in 1g3
0573-0705-12Chapstick4 g in 1 CYLINDERSTICK12 g450 mg in 1g3
0573-0705-12Chapstick1 in 1 BLISTER PACKSTICK450 mg in 1g3
0573-0715-12Chapstick4 g in 1 CYLINDERSTICK8 g450 mg in 1g3
0573-0715-12Chapstick1 in 1 BLISTER PACKSTICK450 mg in 1g3
0573-0725-12Chapstick4 g in 1 CYLINDERSTICK8 g423 mg in 1g3
0573-0725-12Chapstick1 in 1 BLISTER PACKSTICK75 mg in 1g3
0573-2027-01Chapstick1 in 1 PACKAGEKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0701CHAPSTICK (AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM) KIT [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC20240502_0e34fc74-772e-48fd-a353-58807ef412c1.zip
0573-0705CHAPSTICK (AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM) KIT [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC20240502_0e34fc74-772e-48fd-a353-58807ef412c1.zip
0573-0715CHAPSTICK (AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM) KIT [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC20240502_0e34fc74-772e-48fd-a353-58807ef412c1.zip
0573-0725CHAPSTICK (AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM) KIT [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC20240502_0e34fc74-772e-48fd-a353-58807ef412c1.zip
0573-2027CHAPSTICK (AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM) KIT [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC, 9 package rows20240502_0e34fc74-772e-48fd-a353-58807ef412c1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0705-12GM - Gram0573-0705f57c711a-4a41-407f-a88f-bdea0a19da2512022-12-07
0573-0701-51GM - Gram0573-07011e39ab2a-7df8-4022-9cb8-f71b01cc969412022-12-07

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-20270573-2027-01
0573-07250573-0725-12
0573-07150573-0715-12
0573-07050573-0705-12
0573-07010573-0701-12

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 61 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CARNAUBA WAXR12CBM0EIZIACT
CETYL ALCOHOL936JST6JCNIACT
.ALPHA.-TOCOPHEROL LINOLEATE, D-G0N132Q0EDIACT
ISOCETYL STEARATE3RJ7186O9WIACT
LANOLIN7EV65EAW6HIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
SACCHARINFST467XS7DIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WHITE WAX7G1J5DA97FIACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
PETROLATUM4T6H12BN9UACTIB
ARACHIDYL PROPIONATEQV5DAH3MSBIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
CARNAUBA WAXR12CBM0EIZIACT
CETYL ALCOHOL936JST6JCNIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LANOLIN7EV65EAW6HIACT
LEMON OIL, COLD PRESSEDI9GRO824LLIACT
LIGHT MINERAL OILN6K5787QVPIACT
MALTOL3A9RD92BS4IACT
OCTYLDODECANOL461N1O614YIACT
PARAFFINI9O0E3H2ZEIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
D&C RED NO. 6481744AI4OIACT
SACCHARINFST467XS7DIACT
WHITE WAX7G1J5DA97FIACT
PETROLATUM4T6H12BN9UACTIB
ARACHIDYL PROPIONATEQV5DAH3MSBIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
CARNAUBA WAXR12CBM0EIZIACT
CETYL ALCOHOL936JST6JCNIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPIACT
LEVOMENTHOLBZ1R15MTK7IACT
OCTYLDODECANOL461N1O614YIACT
PARAFFINI9O0E3H2ZEIACT

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 · 8 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
ndc (package): 0573-0705-12
ndc (package): 0573-0701-12
ndc (package): 0573-2027-01
ndc (package): 0573-0715-12
ndc (product): 0573-2027
ndc11 (package): 00573070112
ndc11 (package): 00573202701
ndc11 (package): 00573072512
ndc11 (package): 00573070512
ndc11 (package): 00573071512
spl id: 17672368-32db-9bca-e063-6394a90a7c62
spl set id: 0e34fc74-772e-48fd-a353-58807ef412c1
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLCd6eb2ea6-27c7-40a6-a1f0-789ea2131de32024-04-11WarningsExact identifier
ndc (package): 0573-0701-12
ndc (package): 0573-0715-12
ndc11 (package): 00573070112
ndc11 (package): 00573071512
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLC040694f0-b5ba-4203-bde9-699fa9b1afef2024-04-11WarningsExact identifier
ndc (package): 0573-0705-12
ndc (package): 0573-0701-12
ndc11 (package): 00573070112
ndc11 (package): 00573070512
Chapstick Holiday Classics KitWHITE PETROLATUMHaleon US Holdings LLC6df216dc-c03d-463a-8029-5e54c1dc3d272024-04-11WarningsExact identifier
ndc (package): 0573-0705-12
ndc (package): 0573-0701-12
ndc (package): 0573-0715-12
ndc11 (package): 00573070112
ndc11 (package): 00573070512
ndc11 (package): 00573071512
Chapstick Moisturizer OriginalAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC9cd13fbb-887f-46a8-9f0b-4450ad3e07b72024-03-22WarningsExact identifier
ndc (package): 0573-0725-12
ndc (product): 0573-0725
ndc11 (package): 00573072512
ChapStick Classic StrawberryWHITE PETROLATUMHaleon US Holdings LLC3a279496-74c5-4ab1-ba69-06ad4a4f67cf2024-03-21WarningsExact identifier
ndc (package): 0573-0715-12
ndc (product): 0573-0715
ndc11 (package): 00573071512
ChapStick Classic CherryWHITE PETROLATUMHaleon US Holdings LLCdb041b1b-084a-4283-b6ba-4d4bcdc220b32024-03-19WarningsExact identifier
ndc (package): 0573-0705-12
ndc (product): 0573-0705
ndc11 (package): 00573070512
ChapStick Classic OriginalWHITE PETROLATUMHaleon US Holdings LLC42fe0f4a-efb7-4e70-a359-db7dc2ac99052024-03-19WarningsExact identifier
ndc (package): 0573-0701-12
ndc (product): 0573-0701
ndc11 (package): 00573070112

Reported adverse events (FAERS/openFDA)#

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