Home NDC 58443-0182 LifeCell
Product NDC 58443-0182
11-digit product format 584430182
Labeler code 58443
Product ID 58443-0182_9c59abdb-fdcf-4b87-e053-2a95a90a43f4
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate and Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-01-16
Marketing end 0000-00-00
Substance OCTINOXATE; ZINC OXIDE
Active strength 29 mg/mL; mg/mL
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58443-0182-3 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58443-0182-3 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58443-0182-3 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58443-0182-3 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58443-0182-3 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58443-0182-3 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58443-0182-3 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58443-0182-3 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58443-0182-3 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 58443-0182-3 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58443-0182-3 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58443-0182-3 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 ZINC CATION ACTIVE MOIETY 13S1S8SF37 LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 ALMOND OIL INACTIVE INGREDIENT 66YXD4DKO9 LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 BENTONITE INACTIVE INGREDIENT A3N5ZCN45C LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 CARAMEL INACTIVE INGREDIENT T9D99G2B1R LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 CETYL DIMETHICONE 150 INACTIVE INGREDIENT 5L694Y0T22 LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) INACTIVE INGREDIENT V2W71V8T0X LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 CHOLECALCIFEROL INACTIVE INGREDIENT 1C6V77QF41 LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 CYCLOMETHICONE INACTIVE INGREDIENT NMQ347994Z LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 CYCLOMETHICONE 6 INACTIVE INGREDIENT XHK3U310BA LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 DMDM HYDANTOIN INACTIVE INGREDIENT BYR0546TOW LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 GREEN TEA LEAF INACTIVE INGREDIENT W2ZU1RY8B0 LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 HEXYL LAURATE INACTIVE INGREDIENT 4CG9F9W01Q LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 HIGH DENSITY POLYETHYLENE INACTIVE INGREDIENT UG00KM4WR7 LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 ISOCETYL STEARATE INACTIVE INGREDIENT 3RJ7186O9W LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 MELAMINE INACTIVE INGREDIENT N3GP2YSD88 LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTYL STEARATE INACTIVE INGREDIENT 772Y4UFC8B LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 POLYGLYCERYL-4 ISOSTEARATE INACTIVE INGREDIENT 820DPX33S7 LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 TRIETHOXYCAPRYLYLSILANE INACTIVE INGREDIENT LDC331P08E LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R LIFECELL BB CREAM HYDRATING ANTI-OXIDANT BEAUTY BALM BROAD SPECTRUM SPF 30 LIGHT (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58443-0182-3 58443018203 30 mL in 1 BOTTLE (58443-0182-3) 30 ml 2014-01-16 0000-00-00 No No Current