FDA.reportPublic FDA data

ELF Lip Balm SPF 15 Color

Product NDC
76354-013
11-digit product format
763540013
Labeler code
76354
Product ID
76354-013_85c9673e-8c23-4d5e-a317-5bdf16dc579c
Type
HUMAN OTC DRUG
Nonproprietary name
OXYBENZONE
Dosage form
CREAM
Route
TOPICAL
Labeler
J. A. Cosmetics U.S. INC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-10-08
Marketing end
0000-00-00
Substance
OXYBENZONE; OCTINOXATE
Active strength
5 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 productproduct76354-013DDiscontinued by firm2026-08-11
excluded packagepackage76354-01376354-013-01DDiscontinued by firm2026-08-11

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 packagepackage76354-013-01DDiscontinued 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 packagepackage76354-013-01DDiscontinued 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 packagepackage76354-013-01DDiscontinued 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 packagepackage76354-013-01DDiscontinued 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 packagepackage76354-013-01DDiscontinued 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 packagepackage76354-013-01DDiscontinued 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 packagepackage76354-013-01DDiscontinued 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 packagepackage76354-013-01DDiscontinued 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 packagepackage76354-013-01DDiscontinued 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 packagepackage76354-013-01DDiscontinued 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 packagepackage76354-013-01DDiscontinued 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 packagepackage76354-013-01DDiscontinued 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 packagepackage76354-013-01IInactivated by FDA110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76354-013-012019-12-24C16284748780-197449f38-c55d-f6ea-e053-dbdaa90aa703Drug Fact
76354-013-012019-11-13C16284748780-197449f38-c55d-f6ea-e053-dbdaa90aa703Drug Fact

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51ELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51ELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1ELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
CERESININACTIVE INGREDIENTQ1LS2UJO3AELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
D&C RED NO. 6INACTIVE INGREDIENT481744AI4OELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8ELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2
POLYISOBUTYLENE (1100000 MW)INACTIVE INGREDIENTFLT10CH37XELF LIP BALM SPF 15 COLOR (OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC]2