FDA.reportPublic FDA data

Maybelline New York Baby Lips Peppermint Moisturizing Lip Balm SPF 20 Sunscreen

Product NDC
49967-453
Requested package NDC
49967-453-01
11-digit product format
499670453
Labeler code
49967
Product ID
49967-453_93dd505c-3d2c-4a0b-bc86-4dc087316ad3
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate and Octisalate
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-03-01
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE
Active strength
75 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49967-45349967-453-01DDiscontinued by firm2026-10-15

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51MAYBELLINE NEW YORK BABY LIPS PEPPERMINT MOISTURIZING LIP BALM SPF 20 SUNSCREEN (OCTINOXATE AND OCTISALATE) LIPSTICK [L'OREAL USA PRODUCTS INC]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WMAYBELLINE NEW YORK BABY LIPS PEPPERMINT MOISTURIZING LIP BALM SPF 20 SUNSCREEN (OCTINOXATE AND OCTISALATE) LIPSTICK [L'OREAL USA PRODUCTS INC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51MAYBELLINE NEW YORK BABY LIPS PEPPERMINT MOISTURIZING LIP BALM SPF 20 SUNSCREEN (OCTINOXATE AND OCTISALATE) LIPSTICK [L'OREAL USA PRODUCTS INC]1
OCTISALATEACTIVE MOIETY4X49Y0596WMAYBELLINE NEW YORK BABY LIPS PEPPERMINT MOISTURIZING LIP BALM SPF 20 SUNSCREEN (OCTINOXATE AND OCTISALATE) LIPSTICK [L'OREAL USA PRODUCTS INC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-453-01499670453011 TUBE in 1 BLISTER PACK (49967-453-01) > 4.4 g in 1 TUBE1 tube2012-03-010000-00-00NoNoCurrent