EAU THERMALE Avene Hydrance Optimale Hydrating BROAD SPECTRUM SPF 25

Product NDC
67015-0033
11-digit product format
670150033
Labeler code
67015
Product ID
67015-0033_a8b180b8-5460-a7da-e053-2995a90a2259
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Pierre Fabre Dermo-Cosmetique USA, Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-07-16
Marketing end
2022-04-30
Substance
OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE
Active strength
75 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct67015-0033DDiscontinued by firm2026-08-11
excluded packagepackage67015-003367015-0033-0DDiscontinued by firm2026-08-11

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 · 24 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 packagepackage67015-0033-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67015-0033-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67015-0033-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67015-0033-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67015-0033-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67015-0033-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67015-0033-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67015-0033-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67015-0033-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67015-0033-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67015-0033-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67015-0033-0557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51EAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMEAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPEAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51EAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMEAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPEAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
.BETA.-SITOSTEROLINACTIVE INGREDIENTS347WMO6M4EAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933EAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMEAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KEAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZEAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZEAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KEAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309EAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4EAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)INACTIVE INGREDIENT86FQE96TZ4EAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UEAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TEAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UTEAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
SOYBEANINACTIVE INGREDIENTL7HT8F1ZODEAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
SQUALANEINACTIVE INGREDIENTGW89575KF9EAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YEAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
WATERINACTIVE INGREDIENT059QF0KO0REAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEEAU THERMALE AVENE HYDRANCE OPTIMALE HYDRATING BROAD SPECTRUM SPF 25 (TITANIUM DIOXIDE) CREAM [PIERRE FABRE DERMO COSMETIQUE]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67015-0033-0670150033001 TUBE in 1 CARTON (67015-0033-0) > 40 mL in 1 TUBE1 tube2018-07-162022-04-30NoNoCurrent