Lifecell

Product NDC
58443-0193
11-digit product format
584430193
Labeler code
58443
Product ID
58443-0193_9c59abdb-fde1-4b87-e053-2a95a90a43f4
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate and Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Prime Enterprises Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-08-01
Marketing end
0000-00-00
Substance
ZINC OXIDE; OCTINOXATE
Active strength
29 mg/mL; mg/mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58443-0193DDiscontinued by firm2026-10-05
excluded packagepackage58443-019358443-0193-3DDiscontinued by firm2026-10-05

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 packagepackage58443-0193-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58443-0193-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58443-0193-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58443-0193-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58443-0193-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58443-0193-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58443-0193-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58443-0193-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58443-0193-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58443-0193-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58443-0193-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58443-0193-3557ba5c1ecfa…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 INGREDIENT4Y5P7MUD51LIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZLIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51LIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZLIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9LIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XLIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0LIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
BENTONITEINACTIVE INGREDIENTA3N5ZCN45CLIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RLIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
CETYL DIMETHICONE 45INACTIVE INGREDIENTIK315POC44LIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)INACTIVE INGREDIENTV2W71V8T0XLIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41LIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RLIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BALIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWLIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0LIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
HEXYL LAURATEINACTIVE INGREDIENT4CG9F9W01QLIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7LIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYLIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
ISOCETYL STEARATEINACTIVE INGREDIENT3RJ7186O9WLIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
MELANIN SYNTHETIC (TYROSINE, PEROXIDE)INACTIVE INGREDIENTO0CV1RMR44LIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
OCTYL STEARATEINACTIVE INGREDIENT772Y4UFC8BLIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S7LIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08ELIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLIFECELL BROAD SPECTRUM SPF 30 BB CREAM (OCTINOXATE AND ZINC OXIDE) CREAM [PRIME ENTERPRISES INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0193-35844301930350 mL in 1 TUBE (58443-0193-3) 50 ml2013-08-010000-00-00NoNoCurrent