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 176 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UV SOLUTIONS MATTIFYING BROAD SPECTRUM SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENECLINIQUE LABORATORIES LLC4198cfc0-a696-e279-e063-6294a90ac2392025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby RoseZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e9d9419-a7e1-bc42-e063-6394a90af5112025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Shimmer Cream SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e8af968-77d5-1dcd-e063-6394a90a66992025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Peachy ShellZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e9e95c3-4ac8-5962-e063-6294a90a0c022025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 TerracottaZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e9dd230-b087-cda7-e063-6394a90ae0842025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0e9b0642-53ed-ec94-e063-6394a90aec3d2025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Cream SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d977158-8b5d-66ac-e063-6294a90a4d5c2025-10-20WarningsExact identifier
application number: M020
ATTITUDE Oceanly Phyto-Sun Kit SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0eae4b71-60be-9715-e063-6294a90af4632025-10-20WarningsExact identifier
application number: M020
Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum SunscreenZINC OXIDEAttitude DBA 9055-7588 Qubec Inc.9ed70230-980c-474c-9f72-a6be0f3551242025-10-20WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE OCTISALATE OCTOCRYLENEEdgewell Personal Care Brands LLC419b8043-7921-ca77-e063-6394a90a99ba2025-10-20WarningsExact identifier
application number: M020
Illuminizing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC419c8718-6b9e-3df7-e063-6294a90a1e3b2025-10-20WarningsExact identifier
application number: M020
Sonni SunDay SerumZINC OXIDESonni419d4ada-fe9b-b774-e063-6394a90a3d092025-10-20WarningsExact identifier
application number: M020
Lip Clear Lysine Plus ColdstickOCTINOXATE AND OXYBENZONEQuantum, Inc.66f84e56-4a5d-4b71-8bd3-79961e7bf4fe2025-10-20WarningsExact identifier
application number: M020
Super Lysine Plus Strawberry Lip TreatmentOCTINOXATE AND OXYBENZONEQuantum, Inc.2cafc97f-4cd3-4755-b394-3802c28d4ed52025-10-20WarningsExact identifier
application number: M020
Super Lysine Plus Tangerine Lip TreatmentOCTINOXATE AND OXYBENZONEQuantum, Inc.8a00194e-9e28-4257-82e5-59bc44f7897d2025-10-20WarningsExact identifier
application number: M020
Super Lysine Plus ColdstickOCTINOXATE AND OXYBENZONEQuantum, Inc.c9318a8c-ba3b-4068-84df-110c9005ee1d2025-10-20WarningsExact identifier
application number: M020
Terez Honor Hydro SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEWYCREAM INC418d054b-436f-6aa3-e063-6294a90a0f562025-10-19WarningsExact identifier
application number: M020
Danahan Moisture Daily Sunscreen Broad Spectrum SPF 50ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECosmocos Co., Ltd41129799-85ed-2de2-e063-6394a90ab40c2025-10-17WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCc5a67314-e5b2-4dd6-94e9-39c2f286c3462025-10-17WarningsExact identifier
application number: M020
LION POSE GHOST-BUSTER BROAD SPECTRUM SPF 42 SUNSCREENZINC OXIDELion Pose Inc.0310407b-fb74-aa8b-e063-6294a90ad8412025-10-17WarningsExact 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