Home NDC 59886-322 UltrasolSunscreen
Product NDC 59886-322
11-digit product format 598860322
Labeler code 59886
Product ID 59886-322_dc7380b8-5a08-450d-91fd-c863d62f69f6
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octinoxate, Octisalate, Oxybenzone
Dosage form LOTION
Route TOPICAL
Labeler Fischer Pharmaceuticals Ltd
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2010-03-01
Marketing end 0000-00-00
Substance AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength 2 g/100g; g/100g; g/100g; g/100g
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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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 59886-322-55 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.
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 59886-322-55 UltrasolSunscreenSunscreen Lotion SPF45 250 g in 1 BOTTLE, PLASTIC LOTION 250 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Avobenzone ACTIVE INGREDIENT G63QQF2NOX ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Octinoxate ACTIVE INGREDIENT 4Y5P7MUD51 ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Octisalate ACTIVE INGREDIENT 4X49Y0596W ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Oxybenzone ACTIVE INGREDIENT 95OOS7VE0Y ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Avobenzone ACTIVE MOIETY G63QQF2NOX ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Octinoxate ACTIVE MOIETY 4Y5P7MUD51 ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Octisalate ACTIVE MOIETY 4X49Y0596W ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Oxybenzone ACTIVE MOIETY 95OOS7VE0Y ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 ALPHA-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Butylparaben INACTIVE INGREDIENT 3QPI1U3FV8 ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Chlorphenesin INACTIVE INGREDIENT I670DAL4SZ ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Ethylparaben INACTIVE INGREDIENT 14255EXE39 ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Isopropyl Myristate INACTIVE INGREDIENT 0RE8K4LNJS ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Phenoxyethanol INACTIVE INGREDIENT HIE492ZZ3T ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Stearic Acid INACTIVE INGREDIENT 4ELV7Z65AP ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Stearyl Alcohol INACTIVE INGREDIENT 2KR89I4H1Y ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Water INACTIVE INGREDIENT 059QF0KO0R ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59886-322 ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 3 Legacy NDC, 1 package rows 20100301_035383ed-9ebb-4a75-9c3f-cde9ebe8fd4e.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 59886-322-55 59886032255 250 g in 1 BOTTLE, PLASTIC 250 g Historical