Home NDC 59958-240 Skinfuse Shield
Product NDC 59958-240
11-digit product format 599580240
Labeler code 59958
Product ID 59958-240_2b5f4348-2831-1191-e063-6394a90ad402
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Owen Biosciences, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-11-17
Substance ZINC OXIDE
Active strength 21 g/100g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded product product excluded package package 59958-240-02 excluded package package 59958-240-01
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Skinfuse Shield
Brand name suffix SPF 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 21 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59958-240-01 Skinfuse ShieldSPF 30 30 g in 1 TUBE CREAM 30 5 59958-240-02 Skinfuse ShieldSPF 30 60 g in 1 BOTTLE, PUMP CREAM 60 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 ZINC CATION ACTIVE MOIETY 13S1S8SF37 SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 ZINC CATION ACTIVE MOIETY 13S1S8SF37 SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 ETHYL MACADAMIATE INACTIVE INGREDIENT ANA2NCS6V1 SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 ETHYL MACADAMIATE INACTIVE INGREDIENT ANA2NCS6V1 SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 JOJOBA OIL INACTIVE INGREDIENT 724GKU717M SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 JOJOBA OIL INACTIVE INGREDIENT 724GKU717M SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 POLYGLYCERYL-3 RICINOLEATE INACTIVE INGREDIENT MZQ63P0N0W SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 POLYGLYCERYL-3 RICINOLEATE INACTIVE INGREDIENT MZQ63P0N0W SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 PROPANEDIOL INACTIVE INGREDIENT 5965N8W85T SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 PROPANEDIOL INACTIVE INGREDIENT 5965N8W85T SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59958-240 SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20250112_b8e4c11a-4b4f-4e36-a75e-0a73913113d5.zip 59958-240 SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20250114_02d46d44-2476-4f96-9c72-783c392317de.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 109 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bella Blue Skin Care Tinted Sunscreen ZINC OXIDE BELLA BLU STUDIOS INC 3f663fe5-fdfe-d793-e063-6394a90a4f0b 2025-12-17 Warnings Exact identifier application number: M020 Tinted Daily Mineral Shield ZINC OXIDE SIGNATURE MED SPA MT LLC 3aadc018-edbb-033b-e063-6394a90afbe7 2025-12-17 Warnings Exact identifier application number: M020 Non-Tinted Daily Mineral Shield ZINC OXIDE SIGNATURE MED SPA MT LLC 3ab0298d-b2d0-591e-e063-6394a90a3177 2025-12-17 Warnings Exact identifier application number: M020 Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY MINDY LLC 3cce3120-748e-a7fd-e063-6394a90a4d51 2025-12-17 Warnings Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE ESTHETICS BY MINDY LLC 3ccea6c0-8c27-6b26-e063-6294a90a0931 2025-12-17 Warnings Exact identifier application number: M020 Non Tinted Mineral Sunscreen 20Percent Zinc Oxide ZINC OXIDE JKH Aesthetics LLC 369c1d16-5980-e1dc-e063-6394a90a3104 2025-12-17 Exact identifier application number: M020 Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY MINDY LLC 3d5a2662-02e3-3a95-e063-6294a90a8120 2025-12-17 Warnings Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE ESTHETICS BY MINDY LLC 3d5ab3f6-10b9-2a21-e063-6294a90a3428 2025-12-17 Warnings Exact identifier application number: M020 Daily Defense Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JKH Aesthetics LLC 369ccb8f-d9b6-1fd2-e063-6394a90ace20 2025-12-17 Exact identifier application number: M020 Royal Screen ZINC OXIDE QUEENIES BEAUTY LLC 364cafdd-fe86-cb23-e063-6394a90afb09 2025-12-17 Exact identifier application number: M020 Royal Screen ZINC OXIDE QUEENIES BEAUTY LLC 364d2231-3db3-0a59-e063-6394a90a6777 2025-12-17 Exact identifier application number: M020 Mattifying Mineral SPF40 Tinted TITANIUM DIOXIDE, ZINC OXIDE ELIZA ARAKELIAN 36d4f6a7-1115-1efa-e063-6294a90a20c4 2025-12-17 Exact identifier application number: M020 Replenish SPF 40 ZINC OXIDE ELIZA ARAKELIAN 36d69eb5-597d-14a0-e063-6394a90a0a49 2025-12-17 Exact identifier application number: M020 Mattifying Mineral SPF 40 Tinted TITANIUM DIOXIDE, ZINC OXIDE ELIZA ARAKELIAN 36d45700-fc41-ef54-e063-6394a90abcc3 2025-12-17 Exact identifier application number: M020 Gentle Mineral SPF 40 Tinted ZINC OXIDE ELIZA ARAKELIAN 36d66cde-1f90-32b5-e063-6294a90acb34 2025-12-17 Exact identifier application number: M020 Replenish SPF 40 ZINC OXIDE ELIZA ARAKELIAN 36d7148b-b1c4-a6a9-e063-6294a90af92f 2025-12-17 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d85902-fbd2-ba74-e063-6294a90acfc3 2025-12-17 Exact identifier application number: M020 DAY DEFENSE TITANIUM DIOXIDE, ZINC OXIDE THE SKIN CARE SOURCE, INC. 36ad1330-a8bf-e8f8-e063-6394a90acb02 2025-12-17 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d9a8f3-7760-57f3-e063-6394a90a1a1e 2025-12-17 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HSC MIAMI, INC 36d7a18b-5a12-84a9-e063-6394a90a7e38 2025-12-17 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59958-240-01 59958024001 30 g in 1 TUBE (59958-240-01) 30 g 2015-11-12 0000-00-00 No No Current 59958-240-02 59958024002 60 g in 1 BOTTLE, PUMP (59958-240-02) 60 g 2015-11-17 0000-00-00 No No Current