FDA.reportPublic FDA data

Skinfuse Shield

Manufacturer
Owen Biosciences, Inc.
Effective date
2025-01-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:52:14

Label at a glance#

ProductSkinfuse Shield SPF 30
Active ingredientZINC OXIDE
Label structure6 sections

Dosage and administration

Evenly apply to skin before exposure to sun as needed.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 21%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Warnings

WARNINGS SECTION

For external use only.

Avoid Contact with eyes.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Evenly apply to skin before exposure to sun as needed.

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59958-240-022021-07-14C16284748780-1ba0f9c33-1437-a910-e053-dadaa90a0b85Skinfuse Shield 60g
59958-240-022021-01-29C16284748780-1ba0f9c33-1437-a910-e053-dadaa90a0b85Skinfuse Shield 60g

DailyMed Package Descriptions#

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

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
ZINC CATIONACTIVE MOIETY13S1S8SF371
ETHYL MACADAMIATEINACTIVE INGREDIENTANA2NCS6V11
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
POLYGLYCERYL-3 RICINOLEATEINACTIVE INGREDIENTMZQ63P0N0W1
PROPANEDIOLINACTIVE INGREDIENT5965N8W85T1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59958-24059958-240-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
JOJOBA OIL724GKU717MIACT
ZINC OXIDESOI2LOH54ZACTIM
ETHYL MACADAMIATEANA2NCS6V1IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Skinfuse Shield SPF 30ZINC OXIDEOwen Biosciences, Inc.02d46d44-2476-4f96-9c72-783c392317de2025-01-13Exact identifier
ndc (product): 59958-240
Skinfuse Shield SPF 30ZINC OXIDEOwen Biosciences, Inc.b8e4c11a-4b4f-4e36-a75e-0a73913113d52025-01-10WarningsExact identifier
ndc (package): 59958-240-02
ndc (product): 59958-240
ndc11 (package): 59958024002
spl id: 2b5f4348-2831-1191-e063-6394a90ad402
spl set id: b8e4c11a-4b4f-4e36-a75e-0a73913113d5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.