Home NDC 67938-1094 Eight Hour Cream Sun Defense for Face SPF 50 Sunscreen
Product NDC 67938-1094
11-digit product format 679381094
Labeler code 67938
Product ID 67938-1094_3b8062cc-06a4-496e-8aa5-8fe2a940014d
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Elizabeth Arden, Inc
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2010-12-14
Marketing end 0000-00-00
Substance ZINC OXIDE; OCTINOXATE; OCTISALATE
Active strength 6 g/53g; g/53g; g/53g
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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 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 67938-1094-1 Eight Hour Cream Sun Defense for Face SPF 50 Sunscreen 1 in 1 BOX LOTION 1 3 67938-1094-2 Eight Hour Cream Sun Defense for Face SPF 50 Sunscreen 53 g in 1 TUBE LOTION 53 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 OCTISALATE ACTIVE MOIETY 4X49Y0596W EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 ALKYL (C12-15) BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 ARACHIDYL ALCOHOL INACTIVE INGREDIENT 1QR1QRA9BU EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 ARACHIDYL GLUCOSIDE INACTIVE INGREDIENT 6JVW35JOOJ EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 CAPRYLYL GLYCOL INACTIVE INGREDIENT 00YIU5438U EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 DOCOSANOL INACTIVE INGREDIENT 9G1OE216XY EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 ISODECYL NEOPENTANOATE INACTIVE INGREDIENT W60VYE24XC EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 NEOPENTYL GLYCOL DIHEPTANOATE INACTIVE INGREDIENT 5LKW3C543X EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 SORBIC ACID INACTIVE INGREDIENT X045WJ989B EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 TRIETHOXYCAPRYLYLSILANE INACTIVE INGREDIENT LDC331P08E EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 WATER INACTIVE INGREDIENT 059QF0KO0R EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67938-1094 EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN (ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC] 3 Legacy NDC, 2 package rows 20110720_d6f9e599-8516-48ac-a7ab-31c847b235be.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 67938-1094-1 67938109401 1 in 1 BOX Historical 67938-1094-2 67938109402 53 g in 1 TUBE 53 g Historical