FDA.reportPublic FDA data

Eryfotona Ageless

Manufacturer
ISDIN Corp. | Laboratoris Feltor
Effective date
2026-02-23
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-09-03 03:04:03

Label at a glance#

ProductEryfotona Ageless
Active ingredientZinc Oxide
Label structure10 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ) decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. During sun exposure, reapply: after 40 minutes of swimming or sweating. immediately after towel drying. at least every 2 hours. Sun Protection Measures: Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures includ...

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 10.7%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Warning

WARNINGS SECTION

  • For external use only.

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • During sun exposure, reapply:
    • after 40 minutes of swimming or sweating.
    • immediately after towel drying.
    • at least every 2 hours.
  • Sun Protection Measures: Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.- 2 p.m.
    • wear long- sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months: ask a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Diethylhexyl Carbonate, Dibutyl Adipate, Cyclopentasiloxane, Dicaprylyl Carbonate, Alcohol Denat., Cyclohexasiloxane, Butylene Glycol, Silica, PEG-30 Dipolyhydroxystearate, Nylon-12, Glycerin, PEG-10 Dimethicone, Dimethicone, Sodium Chloride, Phenoxyethanol, Iron Oxides, Disteardimonium Hectorite, Triethoxycaprylylsilane, Panthenol, Tocopheryl Acetate, Glyceryl Stearate, Propanediol, Fragrance, Bisabolol, Disodium EDTA, Ethylhexylglycerin, PEG-8, Hydroxypropyl Cyclodextrin, Tocopherol, Lecithin, Plankton Extract, Ascorbyl Palmitate, Sodium Benzoate, Ascorbic Acid, Citric Acid, Palmitoyl Tripeptide-38, Pentapeptide-34 Trifluoroacetate.

Questions or comments?

OTC - QUESTIONS SECTION

Call (862) 242-8129
Monday – Friday
(9 a.m. to 5 p.m. EST)
or visit www.isdin.com

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ISDIN

Eryfotona®
Ageless
Ultralight Emulsion

BROAD SPECTRUM SPF 50

Designed for
Photoaging Defense

100% MINERAL TINTED SUNSCREEN
WITH DNA REPAIRSOMES®

Water resistant
(40 minutes)

3.4 FL OZ (100 mL)

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138429420156852GTIN-13: 8429420156852
EAN-13: 8429420156852
GTIN storage (14 digits): 08429420156852		eryfotona-01.jpg

DailyMed Product Concepts#

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69494-00369494-003-01, 69494-003-02, 69494-003-04, 69494-003-05, 69494-003-06, 69494-003-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
SOYBEAN LECITHIN1DI56QDM62IACT
Disteardimonium HectoriteX687XDK09LIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
Dibutyl AdipateF4K100DXP3IACT
Butylene Glycol3XUS85K0RAIACT
Sodium Chloride451W47IQ8XIACT
PanthenolWV9CM0O67ZIACT
Water059QF0KO0RIACT
Nylon-12446U8J075BIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GlycerinPDC6A3C0OXIACT
Dimethicone92RU3N3Y1OIACT
LEVOMENOL24WE03BX2TIACT
.ALPHA.-Tocopherol Acetate9E8X80D2L0IACT
Ethylhexylglycerin147D247K3PIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
Propanediol5965N8W85TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
TocopherolR0ZB2556P8IACT
Ascorbyl PalmitateQN83US2B0NIACT
Alcohol3K9958V90MIACT
Denatonium Benzoate4YK5Z54AT2IACT
Pentapeptide-34BFO8NU77YFIACT
CYCLOMETHICONE 50THT5PCI0RIACT
Diethylhexyl CarbonateYCD50O0Z6LIACT
Ascorbic AcidPQ6CK8PD0RIACT
Ferric Oxide Red1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
Ferric Oxide YellowEX438O2MRTIACT
CYCLOMETHICONE 6XHK3U310BAIACT
Dicaprylyl Carbonate609A3V1SUAIACT
PhenoxyethanolHIE492ZZ3TIACT
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW)9713Q0S7FOIACT
TriethoxycaprylylsilaneLDC331P08EIACT
PALMITOYL TRIPEPTIDE-38T7A529FB8OIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
HYDROXYPROPYL BETADEX1I96OHX6EKIACT
Pentapeptide-34 TrifluoroacetateSQS1FA1FGWIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72026-02-23full-release2026-06-01 01:46:59

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eryfotona AgelessZINC OXIDEISDIN Corp.a58ac2ed-31b7-4a86-83ca-7630b0c9ea6f2026-02-23WarningsExact identifier
ndc (package): 69494-003-04
ndc (package): 69494-003-06
ndc (package): 69494-003-03
ndc (package): 69494-003-02
ndc (package): 69494-003-05
ndc (package): 69494-003-01
ndc (product): 69494-003
ndc11 (package): 69494000302
ndc11 (package): 69494000304
ndc11 (package): 69494000301
ndc11 (package): 69494000305
ndc11 (package): 69494000306
ndc11 (package): 69494000303
spl id: 98557375-05d8-40ca-90f3-e57029dbf782
spl set id: a58ac2ed-31b7-4a86-83ca-7630b0c9ea6f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.