ELF TINTED MOISTURIZER

Product NDC
76354-112
11-digit product format
763540112
Labeler code
76354
Product ID
76354-112_2bdf899a-05d5-4c24-b7ce-03c8971179de
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OXYBENZONE, OCTISALATE
Dosage form
CREAM
Route
TOPICAL
Labeler
J. A. Cosmetics U.S. INC
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-08-26
Marketing end
0000-00-00
Substance
OCTINOXATE; OXYBENZONE; OCTISALATE
Active strength
8 g/100mL; 1/100mL; g/100mL
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 productproduct76354-112DDiscontinued by firm2026-10-05
excluded packagepackage76354-11276354-112-51DDiscontinued 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 packagepackage76354-112-51DDiscontinued 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 packagepackage76354-112-51DDiscontinued 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 packagepackage76354-112-51DDiscontinued 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 packagepackage76354-112-51DDiscontinued 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 packagepackage76354-112-51DDiscontinued 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 packagepackage76354-112-51DDiscontinued 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 packagepackage76354-112-51DDiscontinued 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 packagepackage76354-112-51DDiscontinued 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 packagepackage76354-112-51DDiscontinued 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 packagepackage76354-112-51DDiscontinued 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 packagepackage76354-112-51DDiscontinued 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 packagepackage76354-112-51DDiscontinued 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 packagepackage76354-112-51IInactivated 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
76354-112-512019-12-26C16284748780-19855e2a2-4a88-60a7-e053-dbdaa90a05bdf793c4c5-2270-483b-818d-c16b7ebfe836
76354-112-512019-11-27C16284748780-19855e2a2-4a88-60a7-e053-dbdaa90a05bdf793c4c5-2270-483b-818d-c16b7ebfe836

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51ELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
OCTISALATEACTIVE INGREDIENT4X49Y0596WELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51ELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
OCTISALATEACTIVE MOIETY4X49Y0596WELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70ELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
CUCUMBERINACTIVE INGREDIENTYY7C30VXJTELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
LAURETH-7INACTIVE INGREDIENTZ95S6G8201ELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
MAGNESIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT0R822556M5ELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
POLYACRYLAMIDE (10000 MW)INACTIVE INGREDIENTE2KR9C9V2IELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
STEARETH-2INACTIVE INGREDIENTV56DFE46J5ELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
STEARETH-21INACTIVE INGREDIENT53J3F32P58ELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
WATERINACTIVE INGREDIENT059QF0KO0RELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEELF TINTED MOISTURIZER SPF-20 (OCTINOXATE, OXYBENZONE, OCTISALATE) CREAM [J. A. COSMETICS U.S. INC]2