ANNA LOTAN Rejuvenating Day Broad Spectrum SPF 34

Product NDC
76446-004
11-digit product format
764460004
Labeler code
76446
Product ID
76446-004_61941da9-5d7e-3786-e053-2a91aa0a709a
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Anna Lotan Ltd
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-06-19
Marketing end
0000-00-00
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
8 mg/100mL; mg/100mL
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct76446-004DDiscontinued by firm2026-10-05
excluded packagepackage76446-00476446-004-75DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76446-004-75d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76446-004-75f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76446-004-752ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76446-004-75a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76446-004-75cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76446-004-75cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76446-004-75302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76446-004-75ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76446-004-750efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76446-004-75ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76446-004-75367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76446-004-75557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51ANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
OCTINOXATEACTIVE MOIETY4Y5P7MUD51ANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
.BETA.-SITOSTEROLINACTIVE INGREDIENTS347WMO6M4ANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
ANHYDROXYLITOLINACTIVE INGREDIENT8XWR7NN42FANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
ARACHIDYL ALCOHOLINACTIVE INGREDIENT1QR1QRA9BUANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
ARACHIDYL GLUCOSIDEINACTIVE INGREDIENT6JVW35JOOJANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
BETAINEINACTIVE INGREDIENT3SCV180C9WANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
BETASIZOFIRANINACTIVE INGREDIENT2X51AD1X3TANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNAANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
CETEARYL ISONONANOATEINACTIVE INGREDIENTP5O01U99NIANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
CETYL PHOSPHATEINACTIVE INGREDIENTVT07D6X67OANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
DIPALMITOYL HYDROXYPROLINEINACTIVE INGREDIENTE6AHA53N1HANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
DOCOSANOLINACTIVE INGREDIENT9G1OE216XYANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
SQUALANEINACTIVE INGREDIENTGW89575KF9ANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
SQUALENEINACTIVE INGREDIENT7QWM220FJHANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8ANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
WATERINACTIVE INGREDIENT059QF0KO0RANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3
XYLITYLGLUCOSIDEINACTIVE INGREDIENTO0IEZ166FBANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ANNA LOTAN LTD]3