Home NDC 68828-165-04 Sunscreen Broad Spectrum SPF 50
Product NDC 68828-165
Requested package NDC 68828-165-04
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
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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…2020-06-10 20:45 UTC · source 2020-06-10 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68828-165-01 Sunscreen Broad Spectrum SPF 50Jafra 125 mL in 1 TUBE CREAM 125 4 68828-165-02 Sunscreen Broad Spectrum SPF 50Jafra 1 in 1 CARTON CREAM 1 4 68828-165-03 Sunscreen Broad Spectrum SPF 50Jafra 200 mL in 1 TUBE CREAM 200 4 68828-165-04 Sunscreen Broad Spectrum SPF 50Jafra 1 in 1 CARTON CREAM 1 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 ALUMINUM STARCH OCTENYLSUCCINATE INACTIVE INGREDIENT I9PJ0O6294 SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 ARACHIDYL ALCOHOL INACTIVE INGREDIENT 1QR1QRA9BU SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 ARACHIDYL GLUCOSIDE INACTIVE INGREDIENT 6JVW35JOOJ SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 ARGININE INACTIVE INGREDIENT 94ZLA3W45F SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) INACTIVE INGREDIENT 59TL3WG5CO SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 CHLORPHENESIN INACTIVE INGREDIENT I670DAL4SZ SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 CYCLOMETHICONE 5 INACTIVE INGREDIENT 0THT5PCI0R SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 DOCOSANOL INACTIVE INGREDIENT 9G1OE216XY SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 ETHYLHEXYLGLYCERIN INACTIVE INGREDIENT 147D247K3P SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 LAUROYL LYSINE INACTIVE INGREDIENT 113171Q70B SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 LEVOMENOL INACTIVE INGREDIENT 24WE03BX2T SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 MICA INACTIVE INGREDIENT V8A1AW0880 SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 PANTHENOL INACTIVE INGREDIENT WV9CM0O67Z SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SUNSCREEN 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 NDC Dashboard title SPL version Validation Dashboard ZIP 68828-165 SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL] 4 Legacy NDC, 4 package rows 20200623_9bf66460-1835-4135-b4be-016ffdabe9a8.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68828-165-04 68828016504 1 TUBE in 1 CARTON (68828-165-04) > 200 mL in 1 TUBE (68828-165-03) 1 tube 2013-02-19 0000-00-00 No No Current