FDA.reportPublic FDA data

Chapstick Moisturizer Cool Mint

Product NDC
0573-0768
11-digit product format
005730768
Labeler code
0573
Product ID
0573-0768_4687328b-9343-4115-9a4b-21df2f93419d
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, octinoxate, and white petrolatum
Dosage form
STICK
Route
TOPICAL
Labeler
Haleon US Holdings LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-28
Substance
AVOBENZONE; OCTINOXATE; PETROLATUM
Active strength
30; 75; 414 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 20 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0573-0768-511332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0573-0768-121332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0573-0768-401332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0573-0768-391332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-0768-39fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-0768-51fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-0768-40fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-0768-12fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-0768-3986f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-0768-5186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-0768-4086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-0768-1286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0573-0768-39bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0573-0768-51bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0573-0768-40bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0573-0768-12bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Chapstick Moisturizer Cool Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
OCTINOXATE75 mg/g
PETROLATUM414 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c1120c7a-1fa8-45a4-8bcf-35d9cc9f2c74Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0573-0768-122024-03-21Drug Facts
0573-0768-392024-03-21Drug Facts
0573-0768-402024-03-21Drug Facts
0573-0768-512024-03-21Drug Facts
0573-0768-122022-01-28Drug Facts
0573-0768-392022-01-28Drug Facts
0573-0768-402022-01-28Drug Facts
0573-0768-512022-01-28Drug 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

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 61 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChapStick Classic SpearmintPETROLATUMHaleon US Holdings LLCd39786e8-bcd8-479d-8990-142a21788a472024-04-12WarningsExact identifier
application number: M016
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLCd6eb2ea6-27c7-40a6-a1f0-789ea2131de32024-04-11WarningsExact identifier
application number: M016
Chapstick Active 2in1 Variety PackZINC OXIDEHaleon US Holdings LLCd1998a9e-d61f-4b4c-91b0-5e66754bcc4a2024-04-11WarningsExact identifier
application number: M016
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLC040694f0-b5ba-4203-bde9-699fa9b1afef2024-04-11WarningsExact identifier
application number: M016
Chapstick Holiday Classics KitWHITE PETROLATUMHaleon US Holdings LLC6df216dc-c03d-463a-8029-5e54c1dc3d272024-04-11WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated SPF15 Triple Force FormulaOCTINOXATE, OXYBENZONE, WHITE PETROLATUMCarma Laboratories, Inc.3eb0f8ff-89e7-4410-8573-3349e49465482024-04-02WarningsExact identifier
application number: M016
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
application number: M016
ChapStick Supreme Classic CherryWHITE PETROLATUMHaleon US Holdings LLC84d8cc38-83e3-49be-b180-d01820525b602024-03-22WarningsExact identifier
application number: M016
Chapstick Moisturizer OriginalAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC9cd13fbb-887f-46a8-9f0b-4450ad3e07b72024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Peachy KeenZINC OXIDEHaleon US Holdings LLCef206fe7-2659-41dc-b117-380af704999b2024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Pretty in PinkZINC OXIDEHaleon US Holdings LLCe686ce23-57bc-4026-be62-d46d90ded4422024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Very BerryZINC OXIDEHaleon US Holdings LLC59023150-65ef-4427-9045-0e64b100cbab2024-03-22WarningsExact identifier
application number: M016
Chapstick Moisturizer Cool MintAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLC33497c07-ad6e-4c50-bc23-a55725b2eae12024-03-21WarningsExact identifier
application number: M016
Chapstick Moisturizer OriginalAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCde250ae9-6e4a-46ca-bcc9-5bb07dbb70c52024-03-21WarningsExact identifier
application number: M016
ChapStick Classic StrawberryWHITE PETROLATUMHaleon US Holdings LLC3a279496-74c5-4ab1-ba69-06ad4a4f67cf2024-03-21WarningsExact identifier
application number: M016
Chapstick Moisturizer Cool MintAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLCc1120c7a-1fa8-45a4-8bcf-35d9cc9f2c742024-03-21WarningsExact identifier
application number: M016
ndc (product): 0573-0768
terrasil Diabetics Ulcer and Sore Relief KitALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions523b6598-8039-4116-b0f8-ba31d7d6ea9d2024-03-20WarningsExact identifier
application number: M016
ChapStick Classic CherryWHITE PETROLATUMHaleon US Holdings LLCdb041b1b-084a-4283-b6ba-4d4bcdc220b32024-03-19WarningsExact identifier
application number: M016
ChapStick Classic OriginalWHITE PETROLATUMHaleon US Holdings LLC42fe0f4a-efb7-4e70-a359-db7dc2ac99052024-03-19WarningsExact identifier
application number: M016
ChapStick Classic SpearmintWHITE PETROLATUMHaleon US Holdings LLC74354d8e-c265-4a27-9715-1a4c157ad8902024-03-19WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0768-12005730768121 CYLINDER in 1 BLISTER PACK (0573-0768-12) / 4 g in 1 CYLINDER1 cylinder2018-06-280000-00-00NoNoCurrent
0573-0768-39005730768393 CYLINDER in 1 BLISTER PACK (0573-0768-39) / 4 g in 1 CYLINDER3 cylinder2018-06-280000-00-00NoNoCurrent
0573-0768-40005730768403 CYLINDER in 1 BLISTER PACK (0573-0768-40) / 4 g in 1 CYLINDER3 cylinder2018-06-280000-00-00NoNoCurrent
0573-0768-51005730768514 g in 1 CYLINDER (0573-0768-51) 4 g2018-06-280000-00-00NoNoCurrent