LIP BALM

Product NDC
76354-110
11-digit product format
763540110
Labeler code
76354
Product ID
76354-110_27bf3917-40f1-45a5-83f9-d398c36439ce
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OXYBENZONE
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
J. A. Cosmetics U.S. INC
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-06-10
Marketing end
0000-00-00
Substance
OCTINOXATE; OXYBENZONE
Active strength
8 g/100g; g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct76354-110DDiscontinued by firm2026-10-15
excluded packagepackage76354-11076354-110-51DDiscontinued 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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76354-110-51DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76354-110-51DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76354-110-51DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76354-110-51DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76354-110-51DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76354-110-51DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76354-110-51DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76354-110-51DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76354-110-51DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76354-110-51DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76354-110-51DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76354-110-51DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage76354-110-51IInactivated by FDA110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76354-110-512019-12-24C16284748780-19855e2a2-5049-60a7-e053-dbdaa90a05bda0f6861c-33c8-4eed-897b-2747f2df8cb9
76354-110-512019-11-27C16284748780-19855e2a2-5049-60a7-e053-dbdaa90a05bda0f6861c-33c8-4eed-897b-2747f2df8cb9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51LIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YLIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51LIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YLIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0LIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
ADIPIC ACIDINACTIVE INGREDIENT76A0JE0FKJLIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8LIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
CERESININACTIVE INGREDIENTQ1LS2UJO3ALIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KLIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
D&C RED NO. 6 BARIUM LAKEINACTIVE INGREDIENTK4XZD9W99KLIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39LIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7LIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GLIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7ULIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
MICAINACTIVE INGREDIENTV8A1AW0880LIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYLIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPLIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZELIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHLIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TLIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
POLYBUTENE (1400 MW)INACTIVE INGREDIENT1NA5AO9GH7LIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S7LIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YLIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) LIPSTICK [J. A. COSMETICS U.S. INC]1