Home NDC 76214-019 ALOE SUN
Product NDC 76214-019
11-digit product format 762140019
Labeler code 76214
Product ID 76214-019_cb4b69e6-01fe-4955-a69c-16ff4169822c
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE
Dosage form SPRAY
Route CUTANEOUS
Labeler SKINFOOD CO., LTD.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2011-03-01
Marketing end 0000-00-00
Substance OCTINOXATE; ENSULIZOLE
Active strength 7 mL/100mL; mL/100mL
NDC exclude flag E
Listing certified through 2018-12-31
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 Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 76214-019-01 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 76214-019-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 76214-019-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 76214-019-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 76214-019-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 76214-019-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 76214-019-01 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 76214-019-01 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 76214-019-01 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 76214-019-01 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 76214-019-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 76214-019-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 76214-019-01 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 76214-019-01 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 76214-019-01 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 76214-019-01 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 76214-019-01 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 76214-019-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 76214-019-01 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 76214-019-01 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 76214-019-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 76214-019-01 E Excluded after deficient or non-compliant submission was not corrected 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 76214-019-01 ALOE SUNSPF28 PA PLUS PLUS 100 mL in 1 BOTTLE SPRAY 100 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ENSULIZOLE ACTIVE INGREDIENT 9YQ9DI1W42 ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 ENSULIZOLE ACTIVE MOIETY 9YQ9DI1W42 ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 ALKYL (C12-15) BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 BEMOTRIZINOL INACTIVE INGREDIENT PWZ1720CBH ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 C12-20 ALKYL GLUCOSIDE INACTIVE INGREDIENT K67N5Z1RUA ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 C14-22 ALCOHOLS INACTIVE INGREDIENT B1K89384RJ ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 CETEARYL OLIVATE INACTIVE INGREDIENT 58B69Q84JO ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 ENZACAMENE INACTIVE INGREDIENT 8I3XWY40L9 ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 METHYLCHLOROISOTHIAZOLINONE INACTIVE INGREDIENT DEL7T5QRPN ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 SORBITAN OLIVATE INACTIVE INGREDIENT MDL271E3GR ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76214-019 ALOE SUN SPF28 PA PLUS PLUS (OCTINOXATE) SPRAY [SKINFOOD CO., LTD.] 1 Legacy NDC, 1 package rows 20110908_a1f76361-23fa-4ef8-96d6-eaf3a6b6540c.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 76214-019-01 76214001901 100 mL in 1 BOTTLE 100 ml Historical