Oil Control

Product NDC
68828-105
11-digit product format
688280105
Labeler code
68828
Product ID
68828-105_c74edc6d-1551-49ee-8287-d12c9b0d8107
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
JAFRA COSMETICS INTERNATIONAL
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-06-05
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
5 g/80mL; g/80mL; g/80mL
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 productproduct68828-105DDiscontinued by firm2026-10-21
excluded packagepackage68828-10568828-105-01DDiscontinued by firm2026-10-21

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 · 24 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 packagepackage68828-105-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68828-105-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68828-105-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68828-105-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68828-105-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68828-105-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68828-105-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68828-105-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68828-105-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68828-105-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68828-105-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68828-105-01557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51OIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51OIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OCTISALATEACTIVE MOIETY4X49Y0596WOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0OIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
ALTHAEA OFFICINALIS ROOTINACTIVE INGREDIENTTRW2FUF47HOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839XOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
CUCUMBERINACTIVE INGREDIENTYY7C30VXJTOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0ROIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
DI-PPG-3 MYRISTYL ETHER ADIPATEINACTIVE INGREDIENTT32481VTXWOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4OIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
HAMAMELIS VIRGINIANA TOPINACTIVE INGREDIENTUDA30A2JJYOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
HYDROGENATED PALM GLYCERIDESINACTIVE INGREDIENTYCZ8EM144QOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
ISOPROPYL ISOSTEARATEINACTIVE INGREDIENTC67IXB9Y7TOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
LAURETH-12INACTIVE INGREDIENTOAH19558U1OIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
MATRICARIA RECUTITA LEAFINACTIVE INGREDIENT6I9LN466F0OIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
MUNG BEANINACTIVE INGREDIENT1LIB31N73GOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
PEG-4 LAURATEINACTIVE INGREDIENTAYF4VM3N1ZOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UTOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
TRIHYDROXYSTEARININACTIVE INGREDIENT06YD7896S3OIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0ROIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
WITHANIA SOMNIFERA FLOWERINACTIVE INGREDIENT2HZ95R7082OIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZOIL CONTROL TESTERS SPF 15 (OCTINOXATE, OCTISALATE, OCTOCRYLENE) LOTION [JAFRA COSMETICS INTERNATIONAL]1