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 125 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Daily Restore ZINC OXIDE TYRLIN ENTERPRISES, INC. 35cead50-86a7-2cf2-e063-6294a90a5f99 2025-12-15 Exact identifier application number: M020 Daily Defense Facial Sunscreen Plus Primer TITANIUM DIOXIDE, ZINC OXIDE LAURA CATHERINE, LLC 36e81e8e-0ba7-93e6-e063-6294a90a4e62 2025-12-15 Exact identifier application number: M020 Sacred Aura ZINC OXIDE IRIA SKIN OASIS LLC 36eaaa54-e288-6590-e063-6394a90a403d 2025-12-15 Exact identifier application number: M020 Daily Defense Facial Sunscreen Plus Primer TITANIUM DIOXIDE, ZINC OXIDE LAURA CATHERINE, LLC 36e84147-5dcd-517a-e063-6394a90a54ee 2025-12-15 Exact identifier application number: M020 Sacred Glow ZINC OXIDE IRIA SKIN OASIS LLC 36ead65c-a46c-7395-e063-6394a90a9e04 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Non Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e91877-c4c4-7fa3-e063-6294a90a1326 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e880af-debc-657f-e063-6394a90ab6ff 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e8b631-03e7-c1de-e063-6294a90aa530 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Non Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e957cf-cfa5-b122-e063-6294a90a78ce 2025-12-15 Exact identifier application number: M020 Skin Shield Plus ZINC OXIDE LAURA CATHERINE, LLC 36e9c2f3-ea89-0de3-e063-6394a90a9fb6 2025-12-15 Exact identifier application number: M020 Skin Shield Plus ZINC OXIDE LAURA CATHERINE, LLC 36e9958b-cc5c-f7ff-e063-6394a90ac80d 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer Matte TITANIUM DIOXIDE, ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d8e8ba-a3dd-257d-e063-6294a90a30d6 2025-12-15 Exact identifier application number: M020 Tinted Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE LAURA CATHERINE, LLC 36e9e8d7-3fcf-1e94-e063-6394a90a8dc6 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer CPlusE Glow ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d968df-5168-61bf-e063-6294a90a94b7 2025-12-15 Exact identifier application number: M020 Advanced Sun Protection TITANIUM DIOXIDE, ZINC OXIDE HELLO BEAUTIFUL SKIN STUDIO 36d45b48-e08d-ef40-e063-6394a90a635c 2025-12-15 Exact identifier application number: M020 Advanced Sun Protection TITANIUM DIOXIDE, ZINC OXIDE HELLO BEAUTIFUL SKIN STUDIO 36d439fb-b9cf-2774-e063-6294a90ae885 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer CPlusE Glow ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d9b48d-e3db-6ae2-e063-6294a90abbf5 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer Matte TITANIUM DIOXIDE, ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d9d83b-7da7-a006-e063-6394a90a9d84 2025-12-15 Exact identifier application number: M020 Advanced Sun Protection TITANIUM DIOXIDE, ZINC OXIDE HELLO BEAUTIFUL SKIN & ACNE 36d3ebc0-1de6-1998-e063-6294a90a02e6 2025-12-15 Exact identifier application number: M020 Sun Safe Lip Balm TITANIUM DIOXIDE, ZINC OXIDE REVIVE IN SOLANO 36c4f0c9-5789-ca58-e063-6394a90a2323 2025-12-15 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