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 firm2026-11-13
excluded packagepackage69494-00369494-003-03DDiscontinued by firm2026-11-13

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 340 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REPAIRWEAR LASER FOCUS LINE SMOOTHING BROAD SPECTRUM SPF 15 -VERY DRY TO DRY COMBINATIONOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC4c40047b-01d6-4221-a044-9f884519bdd52023-10-05WarningsExact identifier
application number: M020
CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO OILYAVOBENZONE AND OCTISALATECLINIQUE LABORATORIES LLC9c9a0fa4-b440-4d7f-805e-d997e120024d2023-10-05WarningsExact identifier
application number: M020
EVEN BETTER GLOW LIGHT REFLECTING MAKEUP BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLC756cb656-2f79-4e7f-b4b3-18d6e89309212023-10-05WarningsExact identifier
application number: M020
bareMinerals ORIGINAL Liquid Mineral Foundation Broad Spectrum SPF 20 Sunscreen FAIR 01TITANIUM DIOXIDEOrveon Global US, LLCf083af9e-e235-5f03-e053-2a95a90a53252023-10-04WarningsExact identifier
application number: M020
Fair Foundation SPF 15ZINC OXIDE, TITANIUM DIOXIDEOrveon Global US, LLC491a5768-1aad-458e-b4d6-72ea085d1d9f2023-10-04WarningsExact identifier
application number: M020
BAREMINERALS SPF 20 CORRECTING CONCEALER Dark 2TITANIUM DIOXIDEOrveon Global US LLC6845acee-5a3f-4c8d-9386-8823b30373f32023-10-04WarningsExact identifier
application number: M020
bareMinerals Complexion Rescue Broad Spectrum SPF 30 Opal 01TITANIUM DIOXIDEOrveon Global US, LLC798934af-f011-4a95-bdb6-b577154713c42023-10-04WarningsExact identifier
application number: M020
bareMinerals Complexion Rescue Brightening Concealer SPF 25 Deep MahoganyTITANIUM DIOXIDEOrveon Global US LLCf03b4fa3-4da9-5e44-e053-2a95a90af3442023-10-04WarningsExact identifier
application number: M020
bareMinerals Complexion Rescue Tinted Hydrating Broad Spectrum SPF 30 Cashew 3.5TITANIUM DIOXIDEOrveon Global US LLC2de76f3c-b438-47ca-84e5-e871e9d995a42023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Fair IvoryTITANIUM DIOXIDEOrveon Global US LLC15c92bce-75f4-40e3-ae28-9bcbc241c8e92023-10-04WarningsExact identifier
application number: M020
bareMinerals Complexion Rescue Defense Radiant Protective Veil Broad Spectrum SPF 30 Soft RadianceTITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC0c2db44d-8604-4883-ab01-f14bc441e4e42023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Beige 12TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC3c35fd13-1a4b-4acf-ada4-16ee2e52dd942023-10-04WarningsExact identifier
application number: M020
bareMinerals Prime Time BB Primer-Cream Broad Spectrum SPF 30 MediumTITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC3cc5b952-4619-4395-97c0-5b68efa9af6d2023-10-04WarningsExact identifier
application number: M020
bareMinerals Skinlongevity Vital Power Moisturizer Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC29c25bc3-902a-41af-996a-8c7e8a4bf5742023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Light 03TITANIUM DIOXIDEOrveon Global US LLCb2909888-5a98-4894-a895-230aa53f64d92023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Tan 19TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCa5888955-f381-4209-9589-bd2e79a84f592023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Light 08TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCad15bdee-67e6-4281-8144-e84b7c478a342023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Tan 18TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCaa4d7945-6cc9-4f20-b588-a5588e57d30a2023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Tan 20TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC2f8b6c57-dcae-408e-898d-d5630deeb0902023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Neutral Dark 24ZINC OXIDEOrveon Global US LLCbeaf1ff7-4942-4ba5-ba25-3287cc409e932023-10-04WarningsExact 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