Home NDC 69594-005 Outback 2 in 1 Protection
Product NDC 69594-005
11-digit product format 695940005
Labeler code 69594
Product ID 69594-005_f7473b9a-663a-4b24-b603-69f765faa818
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE,AVOBENZONE and ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Ultra Mix (Aust) Pty Ltd
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-02-16
Marketing end 0000-00-00
Substance OCTINOXATE; AVOBENZONE; ZINC OXIDE
Active strength 75 mg/mL; mg/mL; mg/mL
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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 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 69594-005-01 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69594-005-01 Outback 2 in 1 Protection 75 mL in 1 TUBE CREAM 75 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX OUTBACK 2 IN 1 PROTECTION (OCTINOXATE,AVOBENZONE AND ZINC OXIDE) CREAM [ULTRA MIX (AUST) PTY LTD ] 1 OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 OUTBACK 2 IN 1 PROTECTION (OCTINOXATE,AVOBENZONE AND ZINC OXIDE) CREAM [ULTRA MIX (AUST) PTY LTD ] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z OUTBACK 2 IN 1 PROTECTION (OCTINOXATE,AVOBENZONE AND ZINC OXIDE) CREAM [ULTRA MIX (AUST) PTY LTD ] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX OUTBACK 2 IN 1 PROTECTION (OCTINOXATE,AVOBENZONE AND ZINC OXIDE) CREAM [ULTRA MIX (AUST) PTY LTD ] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 OUTBACK 2 IN 1 PROTECTION (OCTINOXATE,AVOBENZONE AND ZINC OXIDE) CREAM [ULTRA MIX (AUST) PTY LTD ] 1 ZINC CATION ACTIVE MOIETY 13S1S8SF37 OUTBACK 2 IN 1 PROTECTION (OCTINOXATE,AVOBENZONE AND ZINC OXIDE) CREAM [ULTRA MIX (AUST) PTY LTD ] 1 CITRONELLA OIL INACTIVE INGREDIENT QYO8Q067D0 OUTBACK 2 IN 1 PROTECTION (OCTINOXATE,AVOBENZONE AND ZINC OXIDE) CREAM [ULTRA MIX (AUST) PTY LTD ] 1 EUCALYPTUS POLYBRACTEA LEAF OIL INACTIVE INGREDIENT J1XGA6WROO OUTBACK 2 IN 1 PROTECTION (OCTINOXATE,AVOBENZONE AND ZINC OXIDE) CREAM [ULTRA MIX (AUST) PTY LTD ] 1 LEPTOSPERMUM PETERSONII LEAF OIL INACTIVE INGREDIENT N37UWG52T3 OUTBACK 2 IN 1 PROTECTION (OCTINOXATE,AVOBENZONE AND ZINC OXIDE) CREAM [ULTRA MIX (AUST) PTY LTD ] 1 TEA TREE OIL INACTIVE INGREDIENT VIF565UC2G OUTBACK 2 IN 1 PROTECTION (OCTINOXATE,AVOBENZONE AND ZINC OXIDE) CREAM [ULTRA MIX (AUST) PTY LTD ] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69594-005 OUTBACK 2 IN 1 PROTECTION (OCTINOXATE,AVOBENZONE AND ZINC OXIDE) CREAM [ULTRA MIX (AUST) PTY LTD ] 1 Legacy NDC, 1 package rows 20150217_95adf725-b16a-4617-bbe3-105b82de3961.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 69594-005-01 69594000501 75 mL in 1 TUBE 75 ml Historical