Daily Defense SPF 15

Product NDC
68828-131
11-digit product format
688280131
Labeler code
68828
Product ID
68828-131_d9abf19c-07f0-473b-b028-63fc66c832ed
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Jafra Cosmetics International Inc
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-05-30
Marketing end
0000-00-00
Substance
OCTINOXATE; ZINC OXIDE
Active strength
8 g/100mL; g/100mL
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 productproduct68828-131IInactivated by FDA2026-10-15
excluded packagepackage68828-13168828-131-02IInactivated 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 · 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 packagepackage68828-131-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68828-131-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68828-131-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68828-131-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68828-131-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68828-131-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68828-131-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68828-131-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68828-131-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68828-131-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68828-131-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68828-131-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68828-131-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68828-131-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68828-131-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68828-131-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68828-131-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68828-131-02bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68828-131-028dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68828-131-02e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68828-131-029bebd1f3094a…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
68828-131-022020-01-31C16284748780-19d75b9cf-e87f-f424-e053-dadaa90a57ceTime Protector Daily Defense Cream Broad Spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-131-01Daily Defense SPF 15Jafra50 mL in 1 JARCREAM502
68828-131-02Daily Defense SPF 15Jafra1 in 1 CARTONCREAM12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51DAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZDAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51DAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZDAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0DAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
ALLANTOININACTIVE INGREDIENT344S277G0ZDAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
ASCORBYL METHYLSILANOL PECTINATEINACTIVE INGREDIENTM3PF9237YCDAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70DAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
CERAMIDE 3INACTIVE INGREDIENT4370DF050BDAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
CHLORELLA VULGARISINACTIVE INGREDIENTRYQ4R60M02DAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
CHONDRUS CRISPUSINACTIVE INGREDIENTOQS23HUA1XDAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4DAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
DIISOPROPYL ADIPATEINACTIVE INGREDIENTP7E6YFV72XDAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ODAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBDAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4DAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0DAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
LAURETH-7INACTIVE INGREDIENTZ95S6G8201DAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62DAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UDAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZDAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
POLYACRYLAMIDE (1500 MW)INACTIVE INGREDIENT5D6TC4BRWVDAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
SACCHARIDE ISOMERATEINACTIVE INGREDIENTW8K377W98IDAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
TRIDECYL NEOPENTANOATEINACTIVE INGREDIENT3Z8H1DA7J5DAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCDAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
WATERINACTIVE INGREDIENT059QF0KO0RDAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1
WHEAT GERMINACTIVE INGREDIENTYR3G369F5ADAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-131DAILY DEFENSE SPF 15 JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL INC]2Legacy NDC, 2 package rows20181207_82f91405-b392-4bf1-90da-1f09ae072b86.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68828-131-016882801310150 mL in 1 JAR50 mlHistorical
68828-131-02688280131021 in 1 CARTONHistorical