SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM

Product NDC
49817-0079
11-digit product format
498170079
Labeler code
49817
Product ID
49817-0079_f9a91687-d200-4c2d-b8f5-cc9af21b7fbc
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Guerlain
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-04-10
Marketing end
0000-00-00
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
75 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct49817-0079DDiscontinued by firm2026-10-15
excluded packagepackage49817-007949817-0079-1DDiscontinued by firm2026-10-15

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 · 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 packagepackage49817-0079-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49817-0079-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49817-0079-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49817-0079-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49817-0079-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49817-0079-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49817-0079-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49817-0079-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49817-0079-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49817-0079-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49817-0079-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49817-0079-1557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
.ALPHA.-HEXYLCINNAMALDEHYDEINACTIVE INGREDIENT7X6O37OK2ISUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
.BETA.-CITRONELLOL, (R)-INACTIVE INGREDIENTP01OUT964KSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERINACTIVE INGREDIENTW59H9296ZGSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
BENZYL SALICYLATEINACTIVE INGREDIENTWAO5MNK9TUSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RASUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
BUTYLPHENYL METHYLPROPIONALINACTIVE INGREDIENTT7540GJV69SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
DICAPRYLYL ETHERINACTIVE INGREDIENT77JZM5516ZSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
ETHYLHEXYL ISONONANOATEINACTIVE INGREDIENTI6KB4GE3K4SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
GERANIOLINACTIVE INGREDIENTL837108USYSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785ISUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88ESUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
PEG-60 HYDROGENATED CASTOR OILINACTIVE INGREDIENT02NG325BQGSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4RSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
POLYGLYCERYL-10 STEARATEINACTIVE INGREDIENT90TF85HH91SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
RUSCUS ACULEATUS ROOTINACTIVE INGREDIENTZW12V95I1QSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
SQUALANEINACTIVE INGREDIENTGW89575KF9SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
VIOLA TRICOLORINACTIVE INGREDIENT9Q24RAI43VSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
WATERINACTIVE INGREDIENT059QF0KO0RSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4
XYLOSEINACTIVE INGREDIENTA1TA934AKOSUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM (OCTINOXATE, TITANIUM DIOXIDE) CREAM [GUERLAIN]4