ELF BB

Product NDC
76354-101
11-digit product format
763540101
Labeler code
76354
Product ID
76354-101_475770fe-c7e3-4cba-bfa4-adfe3e67cf7d
Type
HUMAN OTC DRUG
Nonproprietary name
OXYBENZONE, OCTISALATE, AND OCTINOXATE
Dosage form
CREAM
Route
TOPICAL
Labeler
J. A. Cosmetics U.S. INC
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-10-10
Marketing end
0000-00-00
Substance
OXYBENZONE; OCTISALATE; OCTINOXATE
Active strength
4 g/100g; 1/100g; 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 productproduct76354-101DDiscontinued by firm2026-10-05
excluded packagepackage76354-10176354-101-51DDiscontinued 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 · 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 packagepackage76354-101-51DDiscontinued 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 packagepackage76354-101-51DDiscontinued 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 packagepackage76354-101-51DDiscontinued 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 packagepackage76354-101-51DDiscontinued 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 packagepackage76354-101-51DDiscontinued 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 packagepackage76354-101-51DDiscontinued 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 packagepackage76354-101-51DDiscontinued 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 packagepackage76354-101-51DDiscontinued 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 packagepackage76354-101-51DDiscontinued 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 packagepackage76354-101-51DDiscontinued 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 packagepackage76354-101-51DDiscontinued 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 packagepackage76354-101-51DDiscontinued 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 packagepackage76354-101-51IInactivated 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
76354-101-512019-12-18C16284748780-19855e2a2-3b6a-60a7-e053-dbdaa90a05bd2450ab67-6898-4231-816a-0e6bf532fcf3
76354-101-512019-11-27C16284748780-19855e2a2-3b6a-60a7-e053-dbdaa90a05bd2450ab67-6898-4231-816a-0e6bf532fcf3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51ELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
OCTISALATEACTIVE INGREDIENT4X49Y0596WELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
OCTINOXATEACTIVE MOIETY4Y5P7MUD51ELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
OCTISALATEACTIVE MOIETY4X49Y0596WELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
OXYBENZONEACTIVE MOIETY95OOS7VE0YELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
.ALPHA.-BISABOLOL, (+/-)-INACTIVE INGREDIENT36HQN158VCELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)INACTIVE INGREDIENTV2W71V8T0XELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
CUCUMBERINACTIVE INGREDIENTYY7C30VXJTELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BAELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)INACTIVE INGREDIENTAG75W62QYUELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
JOJOBA OILINACTIVE INGREDIENT724GKU717MELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
MICAINACTIVE INGREDIENTV8A1AW0880ELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
POLY(METHYL METHACRYLATE; 450000 MW)INACTIVE INGREDIENTZ47NNT4J11ELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
QUATERNIUM-18 HECTORITEINACTIVE INGREDIENTIIS3YBV1XXELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
SILICONINACTIVE INGREDIENTZ4152N8IUIELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
SORBITAN OLIVATEINACTIVE INGREDIENTMDL271E3GRELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08EELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
WATERINACTIVE INGREDIENT059QF0KO0RELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVELF BB SPF-20 (OXYBENZONE, OCTISALATE, AND OCTINOXATE) CREAM [J. A. COSMETICS U.S. INC]3