FDA.reportPublic FDA data

Oathology Inzincable Sunscreen SPF 50

Manufacturer
SKINOATH LLC | Pure Source, LLC
Effective date
2025-04-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:32

Label at a glance#

ProductOathology Inzincable Sunscreen SPF 50
Active ingredientHOMOSALATE, OCTOCRYLENE, ZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn. higher SPF gives more sunburn protection If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection me...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10.00 %
Octocrylene 10.00 %
Zinc Oxide 5.00 %

Purposes

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings:

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information:

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Acetic Acid, Acetyl Hexapeptide-8, Allantoin, Aloe Barbadensis Leaf Juice, Azelaic Acid, Butyloctyl Salicylate, Caprylyl Glycol, Caprylyl Methicone, Citric Acid, Citrullus Lanatus (Watermelon) Fruit Extract, Cyclopentasiloxane, Glycerin, Glyceryl Laurate, Glyceryl Stearate SE, Glyceryl Undecylenate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Niacinamide, PEG-10 Dimethicone, Pentylene Glycol, Phenoxyethanol, Polysorbate 20, Polysorbate 60, Polyhydroxystearic Acid, Potassium Sorbate, Sodium Polyacrylate, Sorbitan Isostearate, Sorbitan Sesquioleate, Tocopheryl Acetate, Tribehenin PEG-20 Esters, Water (Aqua), Zingiber Officinale (Ginger) Root Oil.

Questions?

OTC - QUESTIONS SECTION

(513) 650-OATH

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelFront labelFront labelBack labelBack label

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
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85562-594-00Oathology Inzincable Sunscreen SPF 50100 mL in 1 BOTTLELOTION1001
85562-594-00Oathology Inzincable Sunscreen SPF 501 in 1 BOXLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85562-594OATHOLOGY INZINCABLE SUNSCREEN SPF 50 (HOMOSALATE, OCTOCRYLENE, ZINC OXIDE) LOTION [SKINOATH LLC]1Current NDC, 2 package rows20250424_d245dfca-9e32-4e71-9df8-58fff84ef6a9.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85562-59485562-594-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETIC ACIDQ40Q9N063PIACT
ACETYL HEXAPEPTIDE-8 AMIDEL4EL31FWILIACT
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
AZELAIC ACIDF2VW3D43YTIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATERMELON231473QB6RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL LAURATEY98611C087IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
ISOHEXADECANE918X1OUF1EIACT
NIACINAMIDE25X51I8RD4IACT
PENTYLENE GLYCOL50C1307PZGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
POLYSORBATE 60CAL22UVI4MIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIBEHENIN PEG-20 ESTERS84K9EH29Y9IACT
WATER059QF0KO0RIACT
GINGER OILSAS9Z1SVUKIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oathology Inzincable Sunscreen SPF 50HOMOSALATE, OCTOCRYLENE, ZINC OXIDESKINOATH LLCd245dfca-9e32-4e71-9df8-58fff84ef6a92025-04-22WarningsExact identifier
ndc (package): 85562-594-00
ndc (product): 85562-594
ndc11 (package): 85562059400
spl id: 335d1200-13b2-9949-e063-6294a90a5182
spl set id: d245dfca-9e32-4e71-9df8-58fff84ef6a9

Reported adverse events (FAERS/openFDA)#

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