BO SPF15

Product NDC
59735-100
11-digit product format
597350100
Labeler code
59735
Product ID
59735-100_74ebb324-403e-4cfe-8f15-e16e7512c936
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octinoxate
Dosage form
LOTION
Route
TOPICAL
Labeler
Mana Products
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-09-27
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTINOXATE
Active strength
3 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59735-100IInactivated by FDA2026-10-20
excluded packagepackage59735-10059735-100-01IInactivated by FDA2026-10-20

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 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59735-100-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59735-100-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59735-100-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59735-100-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59735-100-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59735-100-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59735-100-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59735-100-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59735-100-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59735-100-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59735-100-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59735-100-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage59735-100-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage59735-100-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage59735-100-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage59735-100-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59735-100-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59735-100-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage59735-100-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59735-100-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59735-100-019bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59735-100-012020-01-31C16284748780-19d75b9d0-2ab5-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-100-01BO SPF1575 g in 1 TUBELOTION751

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
OctinoxateACTIVE INGREDIENT4Y5P7MUD51BO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51BO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
(C10-C30)ALKYL METHACRYLATE ESTERINACTIVE INGREDIENTXH2FQZ38D8BO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERINACTIVE INGREDIENTW59H9296ZGBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RABO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27EBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
CETETH-20INACTIVE INGREDIENTI835H2IHHXBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
COCO-GLYCERIDESINACTIVE INGREDIENTISE9I7DNUGBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OILINACTIVE INGREDIENT0QW9S92J3KBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
DIETHYLHEXYL SYRINGYLIDENEMALONATEINACTIVE INGREDIENT3V5U97P248BO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
DISODIUM EDTA-COPPERINACTIVE INGREDIENT6V475AX06UBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785IBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4NBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
NYMPHAEA ALBA FLOWERINACTIVE INGREDIENT40KQ7Q535OBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
O-CYMEN-5-OLINACTIVE INGREDIENTH41B6Q1I9LBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
OCTYLDODECYL NEOPENTANOATEINACTIVE INGREDIENTX8725R883TBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
OLEA EUROPAEA FLOWERINACTIVE INGREDIENT498M34P1VZBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
PEG-75 STEARATEINACTIVE INGREDIENTOT38R0N74HBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
SODIUM OLEATEINACTIVE INGREDIENT399SL044HNBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
SODIUM PALMITOYL PROLINEINACTIVE INGREDIENT64L053FRFOBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E08BO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1
WATERINACTIVE INGREDIENT059QF0KO0RBO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59735-100BO SPF15 (AVOBENZONE, OCTINOXATE) LOTION [MANA PRODUCTS]1Legacy NDC, 1 package rows20130929_791a5de5-62d6-4ac6-a816-0c3b18de75f1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
59735-100-015973501000175 g in 1 TUBE75 gHistorical