Home NDC 66428-002 TheradermSPF 43
Product NDC 66428-002
11-digit product format 664280002
Labeler code 66428
Product ID 66428-002_a9bbadd5-6e2d-4221-b508-a9719779b3ce
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide, Octinoxate, Octisalate
Dosage form EMULSION
Route TOPICAL
Labeler Therapon Skin Health, LP
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-01-20
Marketing end 0000-00-00
Substance ZINC OXIDE; OCTINOXATE; OCTISALATE
Active strength 8 mL/100mL; mL/100mL; mL/100mL
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 66428-002-02 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 66428-002-02 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 66428-002-02 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 66428-002-02 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 66428-002-02 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 66428-002-02 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 66428-002-02 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 66428-002-02 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 66428-002-02 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 66428-002-02 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 66428-002-02 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 66428-002-02 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 66428-002-02 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 66428-002-02 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 66428-002-02 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 66428-002-02 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 66428-002-02 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 66428-002-02 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 66428-002-02 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 66428-002-02 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 66428-002-02 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 66428-002-02 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66428-002-02 TheradermSPF 43 SPF 43 1 in 1 BOX EMULSION 1 2 66428-002-02 TheradermSPF 43 SPF 43 90 mL in 1 TUBE EMULSION 90 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Octinoxate ACTIVE INGREDIENT 4Y5P7MUD51 THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Octisalate ACTIVE INGREDIENT 4X49Y0596W THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Zinc Oxide ACTIVE INGREDIENT SOI2LOH54Z THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Octinoxate ACTIVE MOIETY 4Y5P7MUD51 THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Octisalate ACTIVE MOIETY 4X49Y0596W THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Zinc Oxide ACTIVE MOIETY SOI2LOH54Z THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 .Alpha.-Tocopherol Acetate INACTIVE INGREDIENT 9E8X80D2L0 THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 2-Hydroxyethyl Acrylate INACTIVE INGREDIENT 25GT92NY0C THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Allantoin INACTIVE INGREDIENT 344S277G0Z THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Ascorbyl Palmitate INACTIVE INGREDIENT QN83US2B0N THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Butylene Glycol INACTIVE INGREDIENT 3XUS85K0RA THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Cetearyl Glucoside INACTIVE INGREDIENT 09FUA47KNA THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Coconut Alcohol INACTIVE INGREDIENT 13F4MW8Y9K THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Cyclomethicone 5 INACTIVE INGREDIENT 0THT5PCI0R THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Dimethicone INACTIVE INGREDIENT 92RU3N3Y1O THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Ethylene Oxide INACTIVE INGREDIENT JJH7GNN18P THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Ethylhexyl Isononanoate INACTIVE INGREDIENT I6KB4GE3K4 THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Glycereth-26 INACTIVE INGREDIENT NNE56F2N14 THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Hyaluronate Sodium INACTIVE INGREDIENT YSE9PPT4TH THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Iodopropynyl Butylcarbamate INACTIVE INGREDIENT 603P14DHEB THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Isopropyl Palmitate INACTIVE INGREDIENT 8CRQ2TH63M THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Octyl Stearate INACTIVE INGREDIENT 772Y4UFC8B THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Oleth-3 Phosphate INACTIVE INGREDIENT 8Q0Z18J1VL THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Panthenol INACTIVE INGREDIENT WV9CM0O67Z THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Phenoxyethanol INACTIVE INGREDIENT HIE492ZZ3T THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Polyester-7 INACTIVE INGREDIENT 0841698D2F THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Polyethylene Glycol 350 INACTIVE INGREDIENT ZBR3T82M2V THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Polyisobutylene (1300 MW) INACTIVE INGREDIENT 241BN7J12Y THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Triethoxycaprylylsilane INACTIVE INGREDIENT LDC331P08E THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Water INACTIVE INGREDIENT 059QF0KO0R THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66428-002 THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP] 2 Legacy NDC, 2 package rows 20120124_d83f0f88-8112-47dc-9bc5-c56f86dec51a.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 66428-002-02 66428000202 1 in 1 BOX Historical