Hand Complex Broad Spectrum SPF 15

Product NDC
68828-124
11-digit product format
688280124
Labeler code
68828
Product ID
68828-124_6b90dac3-ff48-4567-bde0-8d3e066f93a5
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octinoxate, Octisalate, Oxybenzone
Dosage form
JELLY
Route
TOPICAL
Labeler
JAFRA COSMETICS INTERNATIONAL
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-02-13
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
3 g/75mL; g/75mL; g/75mL; g/75mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct68828-124IInactivated by FDA2026-10-15
excluded packagepackage68828-12468828-124-02IInactivated by FDA2026-10-15

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 · 36 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 packagepackage68828-124-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68828-124-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68828-124-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68828-124-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68828-124-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68828-124-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68828-124-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68828-124-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68828-124-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68828-124-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68828-124-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68828-124-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68828-124-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68828-124-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68828-124-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68828-124-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68828-124-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68828-124-02bd6a592717d7…303034d00443…

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
68828-124-022022-01-28C16284748780-1d6a99b39-ebdd-a426-e053-dadaa90af4c2Hand Complex Broad Spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-124-01Hand Complex Broad Spectrum SPF 15Jafra75 mL in 1 TUBEJELLY754
68828-124-02Hand Complex Broad Spectrum SPF 15Jafra1 in 1 CARTONJELLY14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51HAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
OCTISALATEACTIVE INGREDIENT4X49Y0596WHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
AVOBENZONEACTIVE MOIETYG63QQF2NOXHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51HAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
OCTISALATEACTIVE MOIETY4X49Y0596WHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0HAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70HAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
HELIANTHUS ANNUUS SPROUTINACTIVE INGREDIENT4P26HG1S5WHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
LAURETH-7INACTIVE INGREDIENTZ95S6G8201HAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
PEG-4 LAURATEINACTIVE INGREDIENTAYF4VM3N1ZHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
POLYACRYLAMIDE (10000 MW)INACTIVE INGREDIENTE2KR9C9V2IHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
ROYAL JELLYINACTIVE INGREDIENTL497I37F0CHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2
WATERINACTIVE INGREDIENT059QF0KO0RHAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-124HAND COMPLEX BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) JELLY [JAFRA COSMETICS INTERNATIONAL]4Legacy NDC, 2 package rows20190420_aa7a30f0-4be0-40b0-8096-5ecb7bb39186.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68828-124-016882801240175 mL in 1 TUBE75 mlHistorical
68828-124-02688280124021 TUBE in 1 CARTON (68828-124-02) > 75 mL in 1 TUBE (68828-124-01) 1 tube2013-02-130000-00-00NoNoCurrent