FDA.reportPublic FDA data

Chapstick Active 2in1

Manufacturer
Haleon US Holdings LLC
Effective date
2024-04-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:10:58

Label at a glance#

ProductChapstick Active 2in1 Variety Pack
Active ingredientZINC OXIDE
Label structure12 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

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 measures...

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 ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 (Unscented)

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, argania spinosa kernel oil, astrocaryum murumuru seed butter, beeswax,

bisabolol, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, carthamus tinctorius

(safflower) seed oil, cocos nucifera (coconut) oil, copernicia cerifera (carnauba) wax, euphorbia

cerifera (candelilla) wax, helianthus annuus (sunflower) seed oil, jojoba esters, mangifera indica

(mango) seed butter, polyhydroxystearic acid, tocopherol, tocopheryl acetate

Inactive ingredients (Fresh Mint)

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, argania spinosa kernel oil, astrocaryum murumuru seed butter, beeswax,

bisabolol, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cocos nucifera (coconut) oil, copernicia cerifera (carnauba) wax, euphorbia cerifera

(candelilla) wax, helianthus annuus (sunflower) seed oil, jojoba esters, mangifera indica (mango) seed

butter, natural flavors, polyhydroxystearic acid, tocopherol, tocopheryl acetate, yellow 6 lake

Inactive ingredients (Wild Berry)

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, argania spinosa kernel oil, astrocaryum murumuru seed butter, beeswax,

bisabolol, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, carthamus tinctorius

(safflower) seed oil, cocos nucifera (coconut) oil, copernicia cerifera (carnauba) wax, euphorbia

cerifera (candelilla) wax, helianthus annuus (sunflower) seed oil, jojoba esters, mangifera indica

(mango) seed butter, natural flavors, polyhydroxystearic acid, ricinus communis (castor) seed oil,

tocopherol, tocopheryl acetate

Questions or comments?

OTC - QUESTIONS SECTION

call weekdays from 8 AM to 6 PM 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

For US Patent or Application status see www.productpats.com

200219

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ChapStick ®

NEW

BRAND LIP CARE

SUNSCREEN

BROAD SPECTRUM SPF 25

ACTIVE2in1

mineral based SPF 25lock in moisture

VARIETY PACK

REEF FRIENDLY

FREE FROM

parabens

phthalates

preservatives

ALL WEATHER

3 STICKS
NET WT 0.18 OZ
(5 g) EACH

200219

Chapstick Active 2 in 1 Variety Pack 3 sticks 0.18 oz (5 g) each
Chapstick Active 2 in 1 Variety Pack 3 sticks 0.18 oz (5 g) each

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0800-01Chapstick Active 2in1Variety Pack5 g in 1 TUBESTICK5 g500 mg in 1g2
0573-0801-01Chapstick Active 2in1Variety Pack5 g in 1 TUBESTICK5 g500 mg in 1g2
0573-0802-01Chapstick Active 2in1Variety Pack5 g in 1 TUBESTICK5 g500 mg in 1g2
0573-0803-01Chapstick Active 2in1Variety Pack1 in 1 PACKAGEKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0800CHAPSTICK ACTIVE 2IN1 VARIETY PACK (ZINC OXIDE) KIT [HALEON US HOLDINGS LLC]2Unmatched20240413_d1998a9e-d61f-4b4c-91b0-5e66754bcc4a.zip
0573-0801CHAPSTICK ACTIVE 2IN1 VARIETY PACK (ZINC OXIDE) KIT [HALEON US HOLDINGS LLC]2Unmatched20240413_d1998a9e-d61f-4b4c-91b0-5e66754bcc4a.zip
0573-0802CHAPSTICK ACTIVE 2IN1 VARIETY PACK (ZINC OXIDE) KIT [HALEON US HOLDINGS LLC]2Unmatched20240413_d1998a9e-d61f-4b4c-91b0-5e66754bcc4a.zip
0573-0803CHAPSTICK ACTIVE 2IN1 VARIETY PACK (ZINC OXIDE) KIT [HALEON US HOLDINGS LLC]2Current NDC, 4 package rows20240413_d1998a9e-d61f-4b4c-91b0-5e66754bcc4a.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-08030573-0803-01
0573-08000573-0800-01
0573-08010573-0801-01
0573-08020573-0802-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 55 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARGAN OIL4V59G5UW9XIACT
ASTROCARYUM MURUMURU SEED BUTTER12V64UPU6RIACT
YELLOW WAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SAFFLOWER OIL65UEH262ISIACT
COCONUT OILQ9L0O73W7LIACT
CARNAUBA WAXR12CBM0EIZIACT
CANDELILLA WAXWL0328HX19IACT
SUNFLOWER OIL3W1JG795YIIACT
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 57-61)12GIN16K1GIACT
HYDROGENATED JOJOBA OIL, RANDOMIZEDQ47ST02F58IACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARGAN OIL4V59G5UW9XIACT
ASTROCARYUM MURUMURU SEED BUTTER12V64UPU6RIACT
YELLOW WAX2ZA36H0S2VIACT
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCIACT
SHEA BUTTERK49155WL9YIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SAFFLOWER OIL65UEH262ISIACT
COCONUT OILQ9L0O73W7LIACT
CARNAUBA WAXR12CBM0EIZIACT
CANDELILLA WAXWL0328HX19IACT
SUNFLOWER OIL3W1JG795YIIACT
HYDROGENATED JOJOBA OIL, RANDOMIZEDQ47ST02F58IACT
MANGIFERA INDICA SEEDEDO6T18WTCIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARGAN OIL4V59G5UW9XIACT
ASTROCARYUM MURUMURU SEED BUTTER12V64UPU6RIACT
YELLOW WAX2ZA36H0S2VIACT

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 Active 2in1 Variety PackZINC OXIDEHaleon US Holdings LLCd1998a9e-d61f-4b4c-91b0-5e66754bcc4a2024-04-11WarningsExact identifier
ndc (package): 0573-0803-01
ndc (package): 0573-0801-01
ndc (package): 0573-0800-01
ndc (package): 0573-0802-01
ndc (product): 0573-0803
ndc11 (package): 00573080201
ndc11 (package): 00573080001
ndc11 (package): 00573080101
ndc11 (package): 00573080301
spl id: 15d4b0bb-6437-712a-e063-6394a90a4f64
spl set id: d1998a9e-d61f-4b4c-91b0-5e66754bcc4a

Reported adverse events (FAERS/openFDA)#

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