ELF SPF 45 Sunscreen UVA/UVB Protection

Product NDC
76354-016
11-digit product format
763540016
Labeler code
76354
Product ID
76354-016_3cfa20d3-3d15-45d6-b446-d434c0f60674
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE
Dosage form
POWDER
Route
TOPICAL
Labeler
J. A. Cosmetics U.S. INC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-10-22
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
23 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 productproduct76354-016DDiscontinued by firm2026-10-05
excluded packagepackage76354-01676354-016-01DDiscontinued 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 packagepackage76354-016-01DDiscontinued 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 packagepackage76354-016-01DDiscontinued 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 packagepackage76354-016-01DDiscontinued 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 packagepackage76354-016-01DDiscontinued 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 packagepackage76354-016-01DDiscontinued 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 packagepackage76354-016-01DDiscontinued 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 packagepackage76354-016-01DDiscontinued 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 packagepackage76354-016-01DDiscontinued 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 packagepackage76354-016-01DDiscontinued 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 packagepackage76354-016-01DDiscontinued 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 packagepackage76354-016-01DDiscontinued 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 packagepackage76354-016-01DDiscontinued 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 packagepackage76354-016-01IInactivated 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
76354-016-012019-12-24C16284748780-197449f38-bf39-f6ea-e053-dbdaa90aa703Drug Fact
76354-016-012019-11-13C16284748780-197449f38-bf39-f6ea-e053-dbdaa90aa703Drug Fact

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2
BISMUTH OXYCHLORIDEINACTIVE INGREDIENT4ZR792I587ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2
GRAPE SEED OILINACTIVE INGREDIENT930MLC8XGGELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2
MAGNESIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT0R822556M5ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2
MICAINACTIVE INGREDIENTV8A1AW0880ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2
SODIUM DEHYDROACETATEINACTIVE INGREDIENT8W46YN971GELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCELF SPF 45 SUNSCREEN UVA/UVB PROTECTION (TITANIUM DIOXIDE) POWDER [J. A. COSMETICS U.S. INC]2