LBEL HYDRA CALME SPF 15 Intensive Moisturizing Facial

Product NDC
43455-0002
11-digit product format
434550002
Labeler code
43455
Product ID
43455-0002_5fa42a37-7be9-4e1f-a4c2-a33d92e085b2
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTISALATE, OXYBENZONE
Dosage form
LOTION
Route
TOPICAL
Labeler
Ventura International, LTD
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-03-25
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
8 mL/100mL; mL/100mL; mL/100mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43455-0002IInactivated by FDA2026-10-15
excluded packagepackage43455-000243455-0002-0IInactivated by FDA2026-10-15
excluded packagepackage43455-000243455-0002-1IInactivated by FDA2026-10-15
excluded packagepackage43455-000243455-0002-2IInactivated by FDA2026-10-15
excluded packagepackage43455-000243455-0002-3IInactivated 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 2 · 110 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 packagepackage43455-0002-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43455-0002-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43455-0002-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43455-0002-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43455-0002-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43455-0002-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43455-0002-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43455-0002-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43455-0002-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43455-0002-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43455-0002-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43455-0002-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43455-0002-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43455-0002-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43455-0002-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43455-0002-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43455-0002-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43455-0002-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43455-0002-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43455-0002-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43455-0002-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43455-0002-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43455-0002-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43455-0002-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43455-0002-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43455-0002-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43455-0002-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43455-0002-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43455-0002-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43455-0002-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43455-0002-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43455-0002-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43455-0002-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43455-0002-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43455-0002-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43455-0002-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43455-0002-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43455-0002-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43455-0002-0ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43455-0002-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43455-0002-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43455-0002-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43455-0002-0367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43455-0002-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43455-0002-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43455-0002-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43455-0002-0557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43455-0002-1557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43455-0002-0LBEL HYDRA CALME SPF 15 Intensive Moisturizing Facial1 mL in 1 POUCHLOTION11
43455-0002-1LBEL HYDRA CALME SPF 15 Intensive Moisturizing Facial3 mL in 1 TUBELOTION31
43455-0002-2LBEL HYDRA CALME SPF 15 Intensive Moisturizing Facial30 mL in 1 JARLOTION301
43455-0002-3LBEL HYDRA CALME SPF 15 Intensive Moisturizing Facial50 mL in 1 TUBELOTION501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51LBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51LBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
OCTISALATEACTIVE MOIETY4X49Y0596WLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RALBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8LBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
C12-20 ALKYL GLUCOSIDEINACTIVE INGREDIENTK67N5Z1RUALBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
C14-22 ALCOHOLSINACTIVE INGREDIENTB1K89384RJLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
C20-22 ALCOHOLSINACTIVE INGREDIENTO4M0347C6ALBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
C20-22 ALKYL PHOSPHATEINACTIVE INGREDIENTL4VKP0Y7RPLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNALBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
CHLORELLA VULGARISINACTIVE INGREDIENTRYQ4R60M02LBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BALBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
ERYTHRITOLINACTIVE INGREDIENTRA96B954X6LBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39LBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4LBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
HOMARINE HYDROCHLORIDEINACTIVE INGREDIENT8866LNG61NLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1ELBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
PEAINACTIVE INGREDIENTW4X7H8GYFMLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
RUBUS CHAMAEMORUS FRUITINACTIVE INGREDIENT74CW8G72Q6LBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
SODIUM ACRYLATEINACTIVE INGREDIENT7C98FKB43HLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)INACTIVE INGREDIENT1DXE3F3OZXLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RLBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEELBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43455-0002LBEL HYDRA CALME SPF 15 INTENSIVE MOISTURIZING FACIAL (OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [VENTURA INTERNATIONAL, LTD]1Legacy NDC, 4 package rows20120404_7c57c221-522e-4874-9f56-31d8ae043f2f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
43455-0002-0434550002001 mL in 1 POUCH1 mlHistorical
43455-0002-1434550002013 mL in 1 TUBE3 mlHistorical
43455-0002-24345500020230 mL in 1 JAR30 mlHistorical
43455-0002-34345500020350 mL in 1 TUBE50 mlHistorical