SKIN DEFENSE MAKEUP

Product NDC
68828-147
11-digit product format
688280147
Labeler code
68828
Product ID
68828-147_9f38acf2-5ebc-4c2a-83b6-2813563edcc3
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE OCTISALATE OXYBENZONE
Dosage form
LOTION
Route
TOPICAL
Labeler
JAFRA COSMETICS INTERNATIONAL
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-04-24
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
6 g/100mL; g/100mL; g/100mL
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68828-147IInactivated by FDA2026-10-05
excluded packagepackage68828-14768828-147-10IInactivated by FDA2026-10-05
excluded packagepackage68828-14768828-147-11IInactivated by FDA2026-10-05

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 2 · 66 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 packagepackage68828-147-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68828-147-11d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68828-147-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68828-147-11f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68828-147-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68828-147-112ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68828-147-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68828-147-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68828-147-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68828-147-11cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68828-147-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68828-147-11cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68828-147-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68828-147-11302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68828-147-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68828-147-11ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68828-147-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68828-147-110efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68828-147-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68828-147-11ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68828-147-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68828-147-11367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68828-147-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68828-147-11557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68828-147-108af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68828-147-118af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68828-147-10834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68828-147-11834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68828-147-101332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68828-147-111332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68828-147-10fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68828-147-11fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68828-147-1086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68828-147-1186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68828-147-10bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68828-147-11bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68828-147-108dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68828-147-118dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68828-147-10e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68828-147-11e2bbac7714bc…27bdfed8d636…

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
68828-147-102020-01-31C16284748780-19d75b9d0-b398-f424-e053-dadaa90a57ceSKIN DEFENSE MAKEUP SPF-15
68828-147-112020-01-31C16284748780-19d75b9d0-b398-f424-e053-dadaa90a57ceSKIN DEFENSE MAKEUP SPF-15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-147-10SKIN DEFENSE MAKEUPSPF-1510 in 1 BOXLOTION102
68828-147-11SKIN DEFENSE MAKEUPSPF-151 in 1 BOXLOTION12
68828-147-17SKIN DEFENSE MAKEUPSPF-158 mL in 1 TUBELOTION82
68828-147-67SKIN DEFENSE MAKEUPSPF-1530 mL in 1 BOTTLELOTION302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
OCTISALATEACTIVE INGREDIENT4X49Y0596WSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
OCTISALATEACTIVE MOIETY4X49Y0596WSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
BIOSACCHARIDE GUM-1INACTIVE INGREDIENTBB4PU4V09HSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RASKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
CHONDRUS CRISPUSINACTIVE INGREDIENTOQS23HUA1XSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
DI-PPG-3 MYRISTYL ETHER ADIPATEINACTIVE INGREDIENTT32481VTXWSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7SKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
HYDROGENATED PALM GLYCERIDESINACTIVE INGREDIENTYCZ8EM144QSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)INACTIVE INGREDIENTJ2S07SB0YLSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
IPOMOEA MAURITIANA TUBERINACTIVE INGREDIENTK67Y2SGX79SKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
ISOPROPYL ISOSTEARATEINACTIVE INGREDIENTC67IXB9Y7TSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62SKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
MACROCYSTIS PYRIFERAINACTIVE INGREDIENTK31S3OG5C4SKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
METHYL METHACRYLATEINACTIVE INGREDIENT196OC77688SKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
OATINACTIVE INGREDIENTZ6J799EAJKSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
PEG-4 LAURATEINACTIVE INGREDIENTAYF4VM3N1ZSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
POLIDRONIUM CHLORIDEINACTIVE INGREDIENT6716Z5YR3GSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UTSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A2SKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
TAGETES ERECTA FLOWERINACTIVE INGREDIENTUH5X33P33ESKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
TREHALOSEINACTIVE INGREDIENTB8WCK70T7ISKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
UREAINACTIVE INGREDIENT8W8T17847WSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
WATERINACTIVE INGREDIENT059QF0KO0RSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZSKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-147SKIN DEFENSE MAKEUP SPF-15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]2Legacy NDC, 4 package rows20120524_9b4dfd5a-afdc-4fd6-8eff-bdc7cfdf65dd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68828-147-106882801471010 in 1 BOXHistorical
68828-147-11688280147111 in 1 BOXHistorical
68828-147-17688280147178 mL in 1 TUBE8 mlHistorical
68828-147-676882801476730 mL in 1 BOTTLE30 mlHistorical