Hand Care Day care Broad Spectrum SPF 15

Product NDC
68828-118
11-digit product format
688280118
Labeler code
68828
Product ID
68828-118_7989a19d-8a58-4fae-a0f7-6a2152a2266c
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octinoxate, Octisalate, Oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Jafra Cosmetics International Inc
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-10-26
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
3 g/100mL; g/100mL; g/100mL; g/100mL
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 productproduct68828-118IInactivated by FDA2026-10-05
excluded packagepackage68828-11868828-118-02IInactivated 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 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 packagepackage68828-118-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68828-118-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68828-118-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68828-118-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68828-118-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68828-118-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68828-118-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68828-118-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68828-118-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68828-118-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68828-118-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68828-118-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68828-118-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68828-118-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68828-118-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68828-118-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68828-118-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68828-118-02bd6a592717d7…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
68828-118-022022-01-28C16284748780-1d6a99b39-6a6f-a426-e053-dadaa90af4c2Day Care Broad Spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-118-01Hand Care Day care Broad Spectrum SPF 15Jafra75 mL in 1 PACKAGELOTION755
68828-118-02Hand Care Day care Broad Spectrum SPF 15Jafra1 in 1 BOXLOTION15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51HAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
OCTISALATEACTIVE INGREDIENT4X49Y0596WHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
AVOBENZONEACTIVE MOIETYG63QQF2NOXHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
OCTINOXATEACTIVE MOIETY4Y5P7MUD51HAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
OCTISALATEACTIVE MOIETY4X49Y0596WHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
OXYBENZONEACTIVE MOIETY95OOS7VE0YHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0HAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70HAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
CHONDRUS CRISPUSINACTIVE INGREDIENTOQS23HUA1XHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
LAURETH-7INACTIVE INGREDIENTZ95S6G8201HAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
LONICERA CAPRIFOLIUM FLOWERINACTIVE INGREDIENT5N1WD9784UHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
MUNG BEANINACTIVE INGREDIENT1LIB31N73GHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
PEG-4 LAURATEINACTIVE INGREDIENTAYF4VM3N1ZHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3THAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
POLYACRYLAMIDE (1500 MW)INACTIVE INGREDIENT5D6TC4BRWVHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4HAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3
WATERINACTIVE INGREDIENT059QF0KO0RHAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-118HAND CARE DAY CARE BROAD SPECTRUM SPF 15 JAFRA (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]5Legacy NDC, 2 package rows20190525_8d459718-20a0-494e-ba2d-b533c95bbd49.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68828-118-016882801180175 mL in 1 PACKAGE75 mlHistorical
68828-118-02688280118021 PACKAGE in 1 BOX (68828-118-02) > 75 mL in 1 PACKAGE (68828-118-01) 1 package2012-10-260000-00-00NoNoCurrent