Cafe Au Lait

Product NDC
68828-083
11-digit product format
688280083
Labeler code
68828
Product ID
68828-083_ff2f0eb4-333b-4c4f-8c8f-5e6b00c557df
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate
Dosage form
LOTION
Route
TOPICAL
Labeler
Jafra Cosmetics International Inc
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-05-16
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; OCTINOXATE
Active strength
8 mL/100mL; mL/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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68828-083IInactivated by FDA2026-10-05
excluded packagepackage68828-08368828-083-01IInactivated 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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68828-083-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68828-083-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68828-083-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68828-083-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68828-083-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68828-083-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68828-083-01IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68828-083-01IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68828-083-01IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68828-083-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68828-083-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68828-083-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68828-083-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68828-083-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68828-083-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68828-083-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68828-083-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68828-083-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68828-083-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68828-083-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68828-083-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68828-083-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
68828-083-012020-01-31C16284748780-19d75b9d0-2e4b-f424-e053-dadaa90a57ceAlways Color Stay-On Makeup SPF 10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-083-01Cafe Au LaitAlways Color Stay-On Makeup SPF 101 in 1 BOXLOTION11
68828-083-01Cafe Au LaitAlways Color Stay-On Makeup SPF 1030 mL in 1 BOTTLE, GLASSLOTION301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
ALUMINUM STEARATEINACTIVE INGREDIENTU6XF9NP8HMCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
ISODODECANEINACTIVE INGREDIENTA8289P68Y2CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM0CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0FCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51ECAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
SYNTHETIC WAX (1900 MW)INACTIVE INGREDIENT5M631N9V0SCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08ECAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
TRIMETHYLSILOXYSILICATE (M/Q 0.66)INACTIVE INGREDIENT5041RX63GNCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1
WATERINACTIVE INGREDIENT059QF0KO0RCAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-083CAFE AU LAIT ALWAYS COLOR STAY-ON MAKEUP SPF 10 (TITANIUM DIOXIDE, OCTINOXATE/ETHYLHEXYLMEHTOXYCINNAMATE) LOTION [JAFRA COSMETICS INTERNATIONAL INC]1Legacy NDC, 2 package rows20120524_d91138de-e6b8-469f-96bf-ea73a872cd27.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68828-083-01688280083011 in 1 BOXHistorical