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 firm2026-10-12
excluded packagepackage69494-00369494-003-03DDiscontinued by firm2026-10-12

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 12 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Juice Body Mist Sunscreen SPF30 - Cotton Candy Skies PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC568083ff-0da9-7f14-e063-6394a90a43012026-07-13WarningsExact identifier
application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Vanilla Breeze PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC3cc62c97-70c5-17f7-e063-6394a90abe252026-07-13WarningsExact identifier
application number: M020
Norwex Lip Glaze Broad Spectrum SPF 30 RoseZINC OXIDENorwex Usa, Inc.565feded-8e25-e628-e063-6294a90aee482026-07-11WarningsExact identifier
application number: M020
PoutScreen Lip Treatment Lemon MeringueAVOBENZONE, OCTINOXATE, OCTOCRYLENENAKED SUNDAYS PTY LTD563e3ab9-4ee2-279c-e063-6294a90a7cf12026-07-10WarningsExact identifier
application number: M020
INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - ROSY BROWNZINC OXIDECOSMAX USA, CORPORATION5643a73d-757c-702d-e063-6294a90a2c122026-07-10WarningsExact identifier
application number: M020
INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - LATTEZINC OXIDECOSMAX USA, CORPORATION5643d655-e335-5643-e063-6394a90a483a2026-07-10WarningsExact identifier
application number: M020
MUSELY DAYCREAM SPF40ZINC OXIDECOSMAX USA, CORPORATION56443156-3edb-a643-e063-6394a90adf9f2026-07-10WarningsExact identifier
application number: M020
Hello Sun Silky Glow Broad Spectrum SPF40ZINC OXIDECosmax USA, Corporation56445f2d-8e5a-34eb-e063-6294a90ae26e2026-07-10WarningsExact identifier
application number: M020
Hello Kitty Fun Broad Spectrum SPF 40ZINC OXIDECosmax USA Corporation5644854e-18d6-617d-e063-6294a90ab3e72026-07-10WarningsExact identifier
application number: M020
VERSED DAILY SUNSCREEN SPF 50HOMOSALATE, OCTISALATE, AVOBENZONECOSMAX USA, CORP5644ca1e-9032-d3fb-e063-6394a90a961e2026-07-10WarningsExact identifier
application number: M020
Hello Kitty Sunny Days Broad Spectrum SPF 40ZINC OXIDECosmax USA Corporation5644855d-f864-e07b-e063-6394a90a51482026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40ZINC OXIDECOSMAX USA, CORP5644d49f-08b9-e806-e063-6294a90a80f92026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT NEUTRALZINC OXIDECOSMAX USA, CORP564682e5-1051-9936-e063-6394a90abe1d2026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT WRMZINC OXIDECOSMAX USA, CORP5646e069-5461-12c5-e063-6294a90abacb2026-07-10WarningsExact identifier
application number: M020
Protect Sport SunscreenBROAD SPECTRUM SPF 30Opal Day Spa564704f2-b26a-d737-e063-6294a90aa6ff2026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM NEUTRALZINC OXIDECOSMAX USA, CORP5647162a-610e-2789-e063-6294a90a75492026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM OLIVEZINC OXIDECOSMAX USA, CORP56472adb-572d-5a52-e063-6294a90a3cc32026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM COOLZINC OXIDECOSMAX USA, CORP56474782-beff-8437-e063-6294a90a83222026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM PEACHZINC OXIDECOSMAX USA, CORP564749f3-e820-9003-e063-6294a90a02652026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 TAN NEUTRALZINC OXIDECOSMAX USA, CORP56477f58-3878-81fa-e063-6294a90a87b72026-07-10WarningsExact 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