VANICREAM Sunscreen BROAD SPECTRUM SPF 30

Product NDC
45334-353
11-digit product format
453340353
Labeler code
45334
Product ID
45334-353_8b21011e-27ed-25d1-e053-2995a90afa60
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Pharmaceutical Specialties, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-04-19
Marketing end
2019-07-31
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
0 g/g; g/g
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45334-353DDiscontinued by firm2026-10-05
excluded packagepackage45334-35345334-353-04DDiscontinued by firm2026-10-05
excluded packagepackage45334-35345334-353-07DDiscontinued 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 · 36 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 packagepackage45334-353-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45334-353-07d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45334-353-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45334-353-07f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45334-353-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45334-353-072ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45334-353-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45334-353-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45334-353-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45334-353-07cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45334-353-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45334-353-07cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45334-353-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45334-353-07302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45334-353-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45334-353-07ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45334-353-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45334-353-070efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage45334-353-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage45334-353-07ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage45334-353-04367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage45334-353-07367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage45334-353-04557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage45334-353-07557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45334-353-04GM - Gram45334-353105686a4-07d0-4ae6-bc0c-31989ec8d25e12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
Titanium DioxideACTIVE MOIETY15FIX9V2JPVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
Zinc OxideACTIVE MOIETYSOI2LOH54ZVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)INACTIVE INGREDIENT035JKJ76MTVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
COCO-GLYCERIDESINACTIVE INGREDIENTISE9I7DNUGVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
DICAPRYLYL CARBONATEINACTIVE INGREDIENT609A3V1SUAVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
HEXANEDIOLINACTIVE INGREDIENTZIA319275IVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
HYDROGENATED POLYBUTENE (1300 MW)INACTIVE INGREDIENT7D1YQ9Y5EZVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9OVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
OCTADECENEINACTIVE INGREDIENTH5ZUQ6V4AKVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
PEG-30 DIPOLYHYDROXYSTEARATEINACTIVE INGREDIENT9713Q0S7FOVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4RVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
SILICA DIMETHYL SILYLATEINACTIVE INGREDIENTEU2PSP0G0WVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
SQUALANEINACTIVE INGREDIENTGW89575KF9VANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
STEARYL DIMETHICONE (400 MPA.S AT 50C)INACTIVE INGREDIENTR327X197HYVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
TRIDECYL SALICYLATEINACTIVE INGREDIENTAZQ08K38Z1VANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08EVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
UBIDECARENONEINACTIVE INGREDIENTEJ27X76M46VANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RVANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]1