FDA.reportPublic FDA data

Eryfotona Ageless

Product NDC
69494-003
11-digit product format
694940003
Labeler code
69494
Product ID
69494-003_98557375-05d8-40ca-90f3-e57029dbf782
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
ISDIN Corp.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-10
Marketing end
2028-11-30
Substance
ZINC OXIDE
Active strength
107 mg/mL
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69494-00369494-003-02DDiscontinued by firm2026-10-27
excluded packagepackage69494-00369494-003-03DDiscontinued by firm2026-10-27

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
Eryfotona Ageless

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE107 mg/mL

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
a58ac2ed-31b7-4a86-83ca-7630b0c9ea6fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69494-003-01Eryfotona Ageless100 mL in 1 BOTTLE, PLASTICLOTION1007
69494-003-01Eryfotona Ageless1 in 1 CARTONLOTION17
69494-003-02Eryfotona Ageless2 mL in 1 BOTTLE, PLASTICLOTION27
69494-003-02Eryfotona Ageless12 in 1 CARTONLOTION127
69494-003-03Eryfotona Ageless2 mL in 1 TUBELOTION27
69494-003-03Eryfotona Ageless1 in 1 PACKETLOTION17
69494-003-04Eryfotona Ageless50 mL in 1 BOTTLE, PLASTICLOTION507
69494-003-04Eryfotona Ageless1 in 1 CARTONLOTION17
69494-003-05Eryfotona Ageless12 in 1 CARTONLOTION127
69494-003-05Eryfotona Ageless4 mL in 1 TUBELOTION47
69494-003-06Eryfotona Ageless1 in 1 PACKETLOTION17
69494-003-06Eryfotona Ageless4 mL in 1 TUBELOTION47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69494-003ERYFOTONA AGELESS (ZINC OXIDE) LOTION [ISDIN CORP.]6Current NDC, Legacy NDC, 12 package rows20240308_a58ac2ed-31b7-4a86-83ca-7630b0c9ea6f.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 227 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC2ee9b3dc-91cd-1af9-e063-6394a90a78e12025-02-24WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC2edc79f8-aac5-15eb-e063-6394a90a97362025-02-23WarningsExact identifier
application number: M020
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AVELLANA 270-COCTINOXATE, ZINC OXIDEBEL STAR S Adc25651b-0e30-c325-e053-2995a90a809e2025-02-21WarningsExact identifier
application number: M020
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AZUCAR BLANCA 110-COCTINOXATE, ZINC OXIDEBEL STAR S Adc129cd6-a173-d2b3-e053-2a95a90aa04e2025-02-21WarningsExact identifier
application number: M020
COOLA Classic Liplux Lip Balm SPF 30 TintedAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCeec6e7c8-17fe-f34b-e053-2995a90a78a02025-02-20WarningsExact identifier
application number: M020
DropsAVOBENZONE OCTISALATE OCTOCRYLENEVacation Inc.1319d6ea-a580-79c5-e063-6394a90a4dca2025-02-20WarningsExact identifier
application number: M020
Vacation SPF 50 Super Spritz Face MistAVOBENZONE, OCTISALATE, OCTOCRYLENEVacation Inc.f67fbe98-93ce-2882-e053-2a95a90ab7132025-02-20WarningsExact identifier
application number: M020
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oilyOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC10edc0c1-9359-4c7a-a56e-bad06fea00562025-02-20WarningsExact identifier
application number: M020
Mineral SPF 30 Brush-On Sun DefenseZINC OXIDEMineral Fusion29733dba-8824-461e-be44-335d6fe50d602025-02-19WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC20cd4d96-2046-3a50-e063-6394a90a12192025-02-18WarningsExact identifier
application number: M020
COOLA Classic Body SPF 30 Pina ColadaAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCedc59de7-c817-1a59-e053-2995a90a34082025-02-17WarningsExact identifier
application number: M020
Liplux SPF 30 Lip BalmCLASSICCOOLA LLCb47b5f3a-43f3-ae7a-e053-2995a90ae16d2025-02-17WarningsExact identifier
application number: M020
COOLA Classic Body SPF 50 Fragrance FreeAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCed207afe-0b10-74c7-e053-2a95a90a9b872025-02-17WarningsExact identifier
application number: M020
Avon Skin-So-Soft Bug Guard plus SPF 30 Sunscreen Gentle Breeze Insect Repellent SunscreenOCTINOXATE, OXYBENZONE, OCTISALATEThe Avon Company2e5d6c93-f091-5388-e063-6394a90ad5602025-02-17WarningsExact identifier
application number: M020
KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc31a98dc7-4b99-d845-e063-6394a90a26702025-02-17WarningsExact identifier
application number: M020
Ultra sheer mineral sunscreen PRO SPF30ZINC OXIDEEden Brands Inc.2ce06566-2eb0-9a00-e063-6394a90a9ba92025-02-14WarningsExact identifier
application number: M020
Cell Fusion C Laser UV Defense Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECMS LAB Inc.2dff0386-e151-089a-e063-6394a90a0f532025-02-14WarningsExact identifier
application number: M020
Cell Fusion C Airy Stick Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECMS LAB Inc.2dffc699-3b56-2c70-e063-6294a90ae2492025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2082aa-5ae3-2c04-e063-6294a90a140b2025-02-14WarningsExact identifier
application number: M020
Coola SPF 30 Mineral Sunscreen Fragrance FreeZINC OXIDECOOLA, LLCedc6048e-0ea0-41c5-e053-2a95a90a96d92025-02-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69494-003-01694940003011 BOTTLE, PLASTIC in 1 CARTON (69494-003-01) / 100 mL in 1 BOTTLE, PLASTIC2019-06-102028-11-30NoNoCurrent
69494-003-026949400030212 BOTTLE, PLASTIC in 1 CARTON (69494-003-02) > 2 mL in 1 BOTTLE, PLASTIC2019-06-100000-00-00NoNoCurrent
69494-003-03694940003032 mL in 1 TUBE2 mlHistorical
69494-003-04694940003041 BOTTLE, PLASTIC in 1 CARTON (69494-003-04) / 50 mL in 1 BOTTLE, PLASTIC2023-05-012027-11-30NoNoHistorical
69494-003-056949400030512 TUBE in 1 CARTON (69494-003-05) / 4 mL in 1 TUBE12 tube2023-12-182028-02-28NoNoHistorical
69494-003-06694940003061 TUBE in 1 PACKET (69494-003-06) / 4 mL in 1 TUBE1 tube2023-12-182028-02-28NoNoHistorical