Home NDC 68634-0031 age renewal firming and hydrating moisturizer
Product NDC 68634-0031
11-digit product format 686340031
Labeler code 68634
Product ID 68634-0031_3d6d5909-5da6-4436-a39a-e7a3a2a3986e
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Octisalate, Oxybenzone, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler AMCOL Health and Beauty Solutions, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2009-12-22
Marketing end 0000-00-00
Substance OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE
Active strength 0 g/g; g/g; g/g; g/g
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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-2 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 68634-0031-1 age renewal firming and hydrating moisturizer 51 g in 1 BOTTLE, GLASS CREAM 51 1 68634-0031-2 age renewal firming and hydrating moisturizer 1 in 1 CARTON CREAM 1 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Octinoxate ACTIVE INGREDIENT 4Y5P7MUD51 AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER (OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.] 1 Octisalate ACTIVE INGREDIENT 4X49Y0596W AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER (OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.] 1 Oxybenzone ACTIVE INGREDIENT 95OOS7VE0Y AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER (OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.] 1 Zinc Oxide ACTIVE INGREDIENT SOI2LOH54Z AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER (OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.] 1 Octinoxate ACTIVE MOIETY 4Y5P7MUD51 AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER (OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.] 1 Octisalate ACTIVE MOIETY 4X49Y0596W AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER (OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.] 1 Oxybenzone ACTIVE MOIETY 95OOS7VE0Y AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER (OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.] 1 Zinc Oxide ACTIVE MOIETY SOI2LOH54Z AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER (OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68634-0031 AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER (OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE) CREAM [AMCOL HEALTH AND BEAUTY SOLUTIONS, INC.] 1 Legacy NDC, 2 package rows 20100216_7c1c1c4b-c91f-4c03-9026-feffa00ece33.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 68634-0031-1 68634003101 51 g in 1 BOTTLE, GLASS 51 g Historical 68634-0031-2 68634003102 1 in 1 CARTON Historical