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#

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 36 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
White Mint SPF 15 Broad Spectrum Lip BalmWHITE MINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc50ff8c38-94f1-f589-e063-6294a90a5ba82026-05-04WarningsExact identifier
application number: M020
Surface Sun SPF 50 MineralZINC OXIDESurface Products Corpcabaf7e1-b940-4d6e-b21b-d99c3a4047a72026-05-04WarningsExact identifier
application number: M020
SPF 50 Dry Touch Continuous No fragranceHOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Surface Products Corp503d6b48-3516-4264-9fe8-71a9939669fe2026-05-04WarningsExact identifier
application number: M020
Surface SPF 50 3oz Tinted mineral sunscreen with Water ResistanceZINC OXIDESurface Products Corp02b770cf-7351-444b-b2c8-ad112e9bea3e2026-05-04WarningsExact identifier
application number: M020
SPF 30 Dry Touch Continuous No fragranceHOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Surface Products Corpd13c9e6e-a5da-4691-8792-9d6025e166d72026-05-04WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUMTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC0206c676-c24d-470e-adb2-7cb3173f37272026-05-04WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - TANTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC5c5aad09-9f93-4634-8db1-c67570b38b2b2026-05-04WarningsExact identifier
application number: M020
OBGE PORE-ZERO Oil CONTROL SUN StickHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAdapt Inc.67209e46-1b7a-42df-b31f-fcb3cefbd7e12026-05-03WarningsExact identifier
application number: M020
EquateOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEWALMART INC2617e5bc-27a2-f187-e063-6394a90a69802026-05-03WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Rice Tinted Mineral Sun CreamZINC OXIDETHANK YOU FARMER CO., LTD20a44597-3d44-f0ea-e063-6294a90a903d2026-05-03WarningsExact identifier
application number: M020
Ultra Violette Sheen Screen Hydrating Lip Balm Last Bite Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEGrace and Fire USA Inc.4df3e90e-98a0-edbf-e063-6394a90ae3c92026-05-01WarningsExact identifier
application number: M020
Ultra Violette Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum SPF 50AVOBENZONE, OCTINOXATE, OCTOCRYLENEGrace and Fire USA Inc.4df6d28b-64ce-59b3-e063-6394a90a63602026-05-01WarningsExact identifier
application number: M020
EXTREME PROTECT SPF 30OCTINOXATE, ZINC OXIDESCIENCE OF SKINCARE LLCecc4d304-e7e2-45b6-b9b2-2c64d36308602026-05-01WarningsExact identifier
application number: M020
Blue Lizard Sport SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories4955fa1c-789d-4f42-af75-70223310644a2026-05-01WarningsExact identifier
application number: M020
Blue Lizard Kids SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesba4ae906-48c0-8384-e053-2995a90afb912026-05-01WarningsExact identifier
application number: M020
Sun Shield Mineral UV Barrier Protect Broad Spectrum SPF 40 SunscreenZINC OXIDEObagi Cosmeceuticals LLC54a3f855-48de-4ae0-b1f0-e957398530652026-05-01WarningsExact identifier
application number: M020
MEDICUBE PDRN HYDRATING UV SERUMHOMOSALATE, OCTOCRYLENE, OCTISALATE, ENSULIZOLEAPR US INC50a73981-985a-0a70-e063-6394a90a89cf2026-04-30WarningsExact identifier
application number: M020
Sky and Sol Body SunscreenNON- NANO ZINC OXIDEDelta Ecommerce LLC2ddaa628-0e81-c8a7-e063-6394a90a84f42026-04-30WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6831832a-e52e-43ea-899f-f5d44bea5a942026-04-30WarningsExact identifier
application number: M020
Carmex 10 count variety pack Lip BalmOCTINOXATE, OXYBENZONE, CAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.9c5168d5-31ed-4ce1-b16a-5f51f7e44ed22026-04-30WarningsExact 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