Sunscreen Broad Spectrum SPF 50

Product NDC
68828-165
Requested package NDC
68828-165-02
11-digit product format
688280165
Labeler code
68828
Product ID
68828-165_a8b44f5e-bd67-80d3-e053-2995a90aa542
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
JAFRA COSMETICS INTERNATIONAL
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-02-19
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68828-16568828-165-02IInactivated 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 · 19 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68828-165-022022-01-28Sunscreen SPF 50
68828-165-042022-01-28Sunscreen SPF 50
68828-165-022020-06-22Sunscreen SPF 50
68828-165-042020-06-22Sunscreen SPF 50
68828-165-022020-01-31Sunscreen SPF 50
68828-165-042020-01-31Sunscreen SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-165-01Sunscreen Broad Spectrum SPF 50Jafra125 mL in 1 TUBECREAM1254
68828-165-02Sunscreen Broad Spectrum SPF 50Jafra1 in 1 CARTONCREAM14
68828-165-03Sunscreen Broad Spectrum SPF 50Jafra200 mL in 1 TUBECREAM2004
68828-165-04Sunscreen Broad Spectrum SPF 50Jafra1 in 1 CARTONCREAM14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
HOMOSALATEACTIVE MOIETYV06SV4M95SSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
OCTISALATEACTIVE MOIETY4X49Y0596WSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
ALLANTOININACTIVE INGREDIENT344S277G0ZSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
ALUMINUM STARCH OCTENYLSUCCINATEINACTIVE INGREDIENTI9PJ0O6294SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
ARACHIDYL ALCOHOLINACTIVE INGREDIENT1QR1QRA9BUSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
ARACHIDYL GLUCOSIDEINACTIVE INGREDIENT6JVW35JOOJSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
ARGININEINACTIVE INGREDIENT94ZLA3W45FSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
DOCOSANOLINACTIVE INGREDIENT9G1OE216XYSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
LAUROYL LYSINEINACTIVE INGREDIENT113171Q70BSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFASUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
MICAINACTIVE INGREDIENTV8A1AW0880SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RSUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-165SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]4Legacy NDC, 4 package rows20200623_9bf66460-1835-4135-b4be-016ffdabe9a8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68828-165-02688280165021 TUBE in 1 CARTON (68828-165-02) > 125 mL in 1 TUBE (68828-165-01) 1 tube2013-02-190000-00-00NoNoCurrent