Home NDC 45334-355-04 VANICREAM Sunscreen BROAD SPECTRUM SPF 35
Product NDC 45334-355
Requested package NDC 45334-355-04
11-digit product format 453340355
Labeler code 45334
Product ID 45334-355_c1226d9a-a52b-79c2-e053-2995a90af018
Type HUMAN OTC DRUG
Nonproprietary name octinoxate and zinc oxide
Dosage form CREAM
Route TOPICAL
Labeler Pharmaceutical Specialties, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-04-18
Marketing end 2022-09-30
Substance OCTINOXATE; 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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 C20-40 ALCOHOLS (MP 79C) INACTIVE INGREDIENT SBX8KS13SG VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) INACTIVE INGREDIENT 035JKJ76MT VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 CYCLOMETHICONE 4 INACTIVE INGREDIENT CZ227117JE VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 CYCLOMETHICONE 5 INACTIVE INGREDIENT 0THT5PCI0R VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 CYCLOMETHICONE 6 INACTIVE INGREDIENT XHK3U310BA VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 DIMETHICONOL GUM INACTIVE INGREDIENT 4MJ9GU3T1P VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 MAGNESIUM CHLORIDE INACTIVE INGREDIENT 02F3473H9O VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 PEG-30 DIPOLYHYDROXYSTEARATE INACTIVE INGREDIENT 9713Q0S7FO VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED INACTIVE INGREDIENT 2PDG9JR76G VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 TRIDECYL NEOPENTANOATE INACTIVE INGREDIENT 3Z8H1DA7J5 VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 TRIETHOXYCAPRYLYLSILANE INACTIVE INGREDIENT LDC331P08E VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 UBIDECARENONE INACTIVE INGREDIENT EJ27X76M46 VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 45334-355-04 45334035504 1 TUBE in 1 CARTON (45334-355-04) > 113 g in 1 TUBE 1 tube 2013-04-18 2022-09-30 No No Current