MediChoice Lip Balm

Product NDC
39892-0900
11-digit product format
398920900
Labeler code
39892
Product ID
39892-0900_99ffca3c-f4c7-1149-e053-2995a90ad7df
Type
HUMAN OTC DRUG
Nonproprietary name
OXYBENZONE, OCTINOXATE
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Owens & Minor Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-12-22
Marketing end
0000-00-00
Substance
OXYBENZONE; OCTINOXATE
Active strength
3 g/100g; g/100g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct39892-0900DDiscontinued by firm2026-10-05
excluded packagepackage39892-090039892-0900-1DDiscontinued by firm2026-10-05

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct39892-0900DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage39892-090039892-0900-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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 INGREDIENT4Y5P7MUD51MEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]4
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YMEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]4
OCTINOXATEACTIVE MOIETY4Y5P7MUD51MEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]4
OXYBENZONEACTIVE MOIETY95OOS7VE0YMEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XMEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZMEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]4
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRMEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]4
CORN OILINACTIVE INGREDIENT8470G57WFMMEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]4
JOJOBA OILINACTIVE INGREDIENT724GKU717MMEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]4
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEMEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]4
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UMEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]4
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92MEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]4
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8MEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]4
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCMEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39892-0900MEDICHOICE LIP BALM SPF 15 (OXYBENZONE, OCTINOXATE) LIPSTICK [OWENS & MINOR INC.]9Legacy NDC20231210_d6744502-eab6-41d7-a424-0533f1dad096.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39892-0900-1398920900014.2 g in 1 DIALPACK (39892-0900-1) 4.2 g2014-12-220000-00-00NoNoCurrent