FDA.reportPublic FDA data

Chapstick

Manufacturer
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Effective date
2021-06-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:07

Label at a glance#

ProductChapstick
Active ingredientAVOBENZONE, OCTINOXATE, PETROLATUM
Label structure4 sections

Label contents#

Full prescribing information#

Moisturizer | 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 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, 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 (Classic 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 dioxide, white wax, yellow 5 lake

Inactive Ingredients (Classic 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 (Classic 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

Additional Information

SPL UNCLASSIFIED SECTION

Paraben 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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0573-2028-02

ChapStick®

PUT YOUR LIPS FIRST®

8 HOUR MOISTURE

SPF15

  • 9 Classic Cherry/Skin Protectant
  • 9 Classic Original/Skin Protectant
  • 9 Classic Strawberry/Skin Protectant
  • 9 Moisturizer Original Skin/Sunscreen/Broad Spectrum SPF 15

NET WT 0.15 OZ
(4 g) EACH

72 INDIVIDUAL STICKS

PAA171900 – Front Carton

Chapstick Fishbowl 72 ct
Chapstick Fishbowl 72 ct

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-2028-022023-01-30C16284748780-1f386c649-fbcb-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-2028-02Chapstick1 in 1 PACKAGEKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-2028CHAPSTICK (AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM) KIT [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]1Legacy NDC, 1 package rows20210630_c2428532-e2a6-494f-a674-181a9f34cfb6.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-20280573-2028-02

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
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
PETROLATUM4T6H12BN9UACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CARNAUBA WAXR12CBM0EIZIACT
CETYL ALCOHOL936JST6JCNIACT
ISOCETYL STEARATE3RJ7186O9WIACT
LANOLIN7EV65EAW6HIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
SACCHARINFST467XS7DIACT
.ALPHA.-TOCOPHEROL LINOLEATE, D-G0N132Q0EDIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WHITE WAX7G1J5DA97FIACT
PETROLATUM4T6H12BN9UACTIB
ARACHIDYL PROPIONATEQV5DAH3MSBIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
CARNAUBA WAXR12CBM0EIZIACT
CETYL ALCOHOL936JST6JCNIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LANOLIN7EV65EAW6HIACT
LEMON OILI9GRO824LLIACT
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

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
c2428532-e2a6-494f-a674-181a9f34cfb6c2428532-e2a6-494f-a674-181a9f34cfb62021-06-18WarningsExact identifier
spl id: c2428532-e2a6-494f-a674-181a9f34cfb6
spl set id: c2428532-e2a6-494f-a674-181a9f34cfb6

Reported adverse events (FAERS/openFDA)#

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