FDA.reportPublic FDA data

Oathology Inzincable Sunscreen SPF 50

Product NDC
85562-594
11-digit product format
855620594
Labeler code
85562
Product ID
85562-594_335d1200-13b2-9949-e063-6294a90a5182
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTOCRYLENE, ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
SKINOATH LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-04
Substance
HOMOSALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
100; 100; 50 mg/mL; mg/mL; mg/mL
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

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
Oathology Inzincable Sunscreen SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE100 mg/mL
OCTOCRYLENE100 mg/mL
ZINC OXIDE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
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
d245dfca-9e32-4e71-9df8-58fff84ef6a9Available 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
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

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 120 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC387d5194-bc12-68c1-e063-6394a90ab1522025-12-15Exact identifier
application number: M020
Tinted Mineral Sun ProtectantTITANIUM DIOXIDE, ZINC OXIDEPANDA PAMPERING LLC387c23c2-a9f0-f484-e063-6394a90a41042025-12-15Exact identifier
application number: M020
Tinted Mineral Sun ProtectantTITANIUM DIOXIDE, ZINC OXIDEPANDA PAMPERING LLC387be96f-8cda-ce02-e063-6394a90abea52025-12-15Exact identifier
application number: M020
Serum Lightly TintedZINC OXIDEPANDA PAMPERING LLC387c593b-c65b-62b5-e063-6294a90ac4c22025-12-15Exact identifier
application number: M020
Serum Lightly TintedZINC OXIDEPANDA PAMPERING LLC387c9167-638c-1e30-e063-6394a90a93742025-12-15Exact identifier
application number: M020
REJUVN8TITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37ede476-43b6-a7c8-e063-6294a90a3e8f2025-12-15Exact identifier
application number: M020
REJUVN8TITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37efa5e1-e88e-d251-e063-6394a90a93712025-12-15Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd330bf-92e4-3664-e063-6294a90a04752025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd37dd1-fd43-7af4-e063-6394a90ae3a02025-12-15WarningsExact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd3dcab-e9fb-0ef5-e063-6394a90acef12025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd40a6a-d52e-ab87-e063-6294a90a966e2025-12-15WarningsExact identifier
application number: M020
20 Zinc Oxide Non-Tinted Mineral SunscreenZINC OXIDEAGELESS SKINCARE INC3766e6c0-8976-509d-e063-6394a90af00f2025-12-15Exact identifier
application number: M020
20 Zinc Oxide Tinted Mineral SunscreenZINC OXIDEAGELESS SKINCARE INC3766b00f-ceda-a6f9-e063-6294a90aff5d2025-12-15Exact identifier
application number: M020
Mattifying Skin PrimerTITANIUM DIOXIDE, ZINC OXIDESKIN MAVEN37662032-2842-1982-e063-6294a90a49a02025-12-15Exact identifier
application number: M020
Moisturizing Face and Body SPFZINC OXIDESKIN MAVEN376645ee-7ea8-e738-e063-6394a90a119b2025-12-15Exact identifier
application number: M020
Mermaid Glow And Go Non Tinted Mineral SunscreenZINC OXIDEMermaid Glow LLC3985a298-fe0b-c296-e063-6294a90ab6c02025-12-15Exact identifier
application number: M020
Mermaid Glow And Go Non Tinted Mineral SunscreenZINC OXIDEMermaid Glow LLC39856675-c110-a7a7-e063-6294a90ac6af2025-12-15Exact identifier
application number: M020
Bio H Plus Daily Defense And RevitalizeZINC OXIDEBIOHEALTH PLUS LLC3764f723-cc7a-2128-e063-6294a90ac8942025-12-15Exact identifier
application number: M020
Extreme Protection Non TintedZINC OXIDEBIOHEALTH PLUS LLC37656077-5185-817a-e063-6394a90adf5a2025-12-15Exact identifier
application number: M020
Deluxe Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDEBIOHEALTH PLUS LLC37657895-5fec-82d0-e063-6294a90acf672025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85562-594-00855620594001 BOTTLE in 1 BOX (85562-594-00) / 100 mL in 1 BOTTLE1 bottle2025-03-04NoNoCurrent