FDA.reportPublic FDA data

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
DatasetScopePackage NDC
excluded productproduct
excluded productproduct
excluded packagepackage59958-240-02
excluded packagepackage59958-240-01

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
IngredientStrength
ZINC OXIDE21 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b8e4c11a-4b4f-4e36-a75e-0a73913113d5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
59958-240-012021-07-14ba0f9c33-32f1-a910-e053-dadaa90a0b85Skinfuse Shield 30g
59958-240-022021-07-14ba0f9c33-1437-a910-e053-dadaa90a0b85Skinfuse Shield 60g
59958-240-012021-01-29ba0f9c33-32f1-a910-e053-dadaa90a0b85Skinfuse Shield 30g
59958-240-022021-01-29ba0f9c33-1437-a910-e053-dadaa90a0b85Skinfuse Shield 60g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59958-240-01Skinfuse ShieldSPF 3030 g in 1 TUBECREAM305
59958-240-02Skinfuse ShieldSPF 3060 g in 1 BOTTLE, PUMPCREAM605

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
ETHYL MACADAMIATEINACTIVE INGREDIENTANA2NCS6V1SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
ETHYL MACADAMIATEINACTIVE INGREDIENTANA2NCS6V1SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MSKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MSKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
POLYGLYCERYL-3 RICINOLEATEINACTIVE INGREDIENTMZQ63P0N0WSKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
POLYGLYCERYL-3 RICINOLEATEINACTIVE INGREDIENTMZQ63P0N0WSKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TSKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TSKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59958-240SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]5Current NDC, Legacy NDC, 1 package rows20250112_b8e4c11a-4b4f-4e36-a75e-0a73913113d5.zip
59958-240SKINFUSE SHIELD SPF 30 (ZINC OXIDE) CREAM [OWEN BIOSCIENCES, INC.]5Current NDC, Legacy NDC, 1 package rows20250114_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 145 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEASHLEY SAMAI38f457fa-0e95-7298-e063-6394a90adda82025-12-09Exact identifier
application number: M020
Non-Tinted Mineral SunscreenZINC OXIDEOLGA KLIMOV INC387b41a4-057f-88af-e063-6394a90adbbe2025-12-09Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDEOLGA KLIMOV INC387b8ae6-c48b-905c-e063-6394a90a31fb2025-12-09Exact identifier
application number: M020
Tinted Primer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECECILIA EDWARDS36ea709b-3536-5052-e063-6394a90a48f92025-12-09Exact identifier
application number: M020
Age Defying Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDEMARK SCHWARTZ CLINICAL SKINCARE, INC.3b028159-f240-2cf2-e063-6294a90a32b52025-12-09WarningsExact identifier
application number: M020
Ultimate Mineral ProtectionZINC OXIDEMARK SCHWARTZ CLINICAL SKINCARE, INC.3b02bf69-b648-56e1-e063-6294a90aeef32025-12-09WarningsExact identifier
application number: M020
G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREENZINC OXIDE, TITANIUM DIOXIDELABORATOIRES DERMO-COSMETIK INC.01dcfd14-7a1d-98fa-e063-6294a90a03362025-12-09WarningsExact identifier
application number: M020
Tinted Primer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECECILIA EDWARDS3aff2074-1514-b5c5-e063-6394a90a75722025-12-09Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER3729d270-64ac-4d2e-e063-6294a90aeb2c2025-12-09Exact identifier
application number: M020
Non Tinted Replenishing Daily ProtectionZINC OXIDELUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER372a41f6-40f6-4971-e063-6394a90a83e02025-12-09Exact identifier
application number: M020
Stay Shady Non-Tinted Mineral SunscreenZINC OXIDEAMOIE ALAYVILLA3b277237-3a2e-1fb0-e063-6294a90adf202025-12-09WarningsExact identifier
application number: M020
Stay Shady Non-Tinted Mineral SunscreenZINC OXIDEAMOIE ALAYVILLA3b27225f-4589-d915-e063-6294a90a72252025-12-09WarningsExact identifier
application number: M020
Replenishing Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEBeauty Journey Studio LLC3738a0c3-5c07-e49b-e063-6394a90a38e92025-12-09Exact identifier
application number: M020
Replenishing Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEBeauty Journey Studio LLC37385fc6-1cde-8aa6-e063-6294a90a60172025-12-09Exact identifier
application number: M020
Replenishing Tinted SunscreenZINC OXIDEBeauty Journey Studio LLC3738e5e0-f6d9-0568-e063-6294a90a67b62025-12-09Exact identifier
application number: M020
JAYSUING Matte Sun StickTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.456b44da-02f3-93a0-e063-6294a90a8d062025-12-08WarningsExact identifier
application number: M020
JAYSUING Matte Sun StickTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.456c2974-d499-7841-e063-6294a90a98eb2025-12-08WarningsExact identifier
application number: M020
JAYSUING Ginseng Moist Sun SerumTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.456cfa70-f524-f5cb-e063-6394a90ae7dc2025-12-08WarningsExact identifier
application number: M020
Face and Body SunscreenNON-NANO ZINC OXIDE 25%Guangzhou Shengyanghui Industrial Trading Co., Ltd3ee96538-06e8-75b1-e063-6394a90a52852025-12-08WarningsExact identifier
application number: M020
Safe Sea SPF sport 65HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD0ed3242b-ac35-4d98-a777-1e44bb32a4672025-12-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59958-240-015995802400130 g in 1 TUBE (59958-240-01) 30 g2015-11-120000-00-00NoNoCurrent
59958-240-025995802400260 g in 1 BOTTLE, PUMP (59958-240-02) 60 g2015-11-170000-00-00NoNoCurrent