Home NDC 59886-320 UltrasolSunscreen
Product NDC 59886-320
11-digit product format 598860320
Labeler code 59886
Product ID 59886-320_91453fc8-b945-4cdc-a3fd-5540b8158873
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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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 59886-320-55 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59886-320-55 UltrasolSunscreenSunscreen Lotion SPF 34 250 g in 1 BOTTLE, PLASTIC LOTION 250 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Avobenzone ACTIVE INGREDIENT G63QQF2NOX ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Octinoxate ACTIVE INGREDIENT 4Y5P7MUD51 ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Octisalate ACTIVE INGREDIENT 4X49Y0596W ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Oxybenzone ACTIVE INGREDIENT 95OOS7VE0Y ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Avobenzone ACTIVE MOIETY G63QQF2NOX ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Octinoxate ACTIVE MOIETY 4Y5P7MUD51 ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Octisalate ACTIVE MOIETY 4X49Y0596W ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Oxybenzone ACTIVE MOIETY 95OOS7VE0Y ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 ALPHA-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Butylparaben INACTIVE INGREDIENT 3QPI1U3FV8 ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Chlorphenesin INACTIVE INGREDIENT I670DAL4SZ ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Ethylparaben INACTIVE INGREDIENT 14255EXE39 ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Isopropyl Myristate INACTIVE INGREDIENT 0RE8K4LNJS ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Phenoxyethanol INACTIVE INGREDIENT HIE492ZZ3T ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Stearic Acid INACTIVE INGREDIENT 4ELV7Z65AP ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Stearyl Alcohol INACTIVE INGREDIENT 2KR89I4H1Y ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Water INACTIVE INGREDIENT 059QF0KO0R ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59886-320 ULTRASOLSUNSCREEN SUNSCREEN LOTION SPF 34 (AVOBENZONE , OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD] 2 Legacy NDC, 1 package rows 20100301_876d12b1-51b7-409e-b43f-89583bf60709.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 59886-320-55 59886032055 250 g in 1 BOTTLE, PLASTIC 250 g Historical