FDA.reportPublic FDA data

Eryfotona

Manufacturer
ISDIN Corp. | Laboratoris Feltor
Effective date
2026-06-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
weekly-update
Hydrated at
2026-07-17 21:41:50

Label at a glance#

ProductEryfotona Ageless Tinted Lightweight Emulsion Sunscreen
Active ingredientTitanium Dioxide
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

shake well before use apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating children under 6 months of age: Ask a doctor Sun Protection Measures. Spending time in the sun increases your 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 ...

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

Titanium Dioxide 16.1%

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

Warnings

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your 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-sleeved shirts, pants, hats, and sunglasses.

Other information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol Dicaprylate/Dicaprate, Dimethicone, C15-19 Alkane, Dicaprylyl Carbonate, Silica, Dibutyl Adipate, Alcohol Denat., PEG-30 Dipolyhydroxystearate, Polyglyceryl-2 Dipolyhydroxystearate, Iron Oxides, Caprylic/Capric Triglyceride, Glycerin, Butyloctyl Salicylate, Magnesium Sulfate, VP/Eicosene Copolymer, 1,2-Hexanediol, Bakuchiol, Caprylyl Glycol, Fragrance, Disteardimonium Hectorite, Tocopheryl Acetate, Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Hyaluronate, Propylene Carbonate, PEG-10 Dimethicone, Tetrasodium Glutamate Diacetate, Triethoxycaprylylsilane, Hydroxypropyl Cyclodextrin, Lecithin, Plankton Extract, Hydroxyacetophenone, Phenethyl Alcohol, Tocopherol, Palmitoyl Tripeptide-38

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 Tinted

Lightweight Emulsion Sunscreen

BROAD SPECTRUM SPF 50

Designed for
Photoaging Defense

100% MINERAL UV FILTER*
AND DOUBLE HELIX
REPAIRSOMES® COMPLEX

3.4 FL OZ (100 mL)

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

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69494-02269494-022-01, 69494-022-02, 69494-022-04, 69494-022-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Water059QF0KO0RIACT
Propylene Glycol Dicaprylate/DicaprateO4446S9CRAIACT
Dimethicone92RU3N3Y1OIACT
C15-19 AlkaneCI87N1IM01IACT
Dicaprylyl Carbonate609A3V1SUAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
Dibutyl AdipateF4K100DXP3IACT
Alcohol3K9958V90MIACT
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW)9713Q0S7FOIACT
Polyglyceryl-2 Dipolyhydroxystearate9229XJ4V12IACT
Ferric Oxide Red1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
Ferric Oxide YellowEX438O2MRTIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GlycerinPDC6A3C0OXIACT
Butyloctyl Salicylate2EH13UN8D3IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
1,2-HexanediolTR046Y3K1GIACT
BakuchiolOT12HJU3ARIACT
Caprylyl Glycol00YIU5438UIACT
Disteardimonium HectoriteX687XDK09LIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
HYALURONATE SODIUMYSE9PPT4THIACT
Propylene Carbonate8D08K3S51EIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
Tetrasodium Glutamate Diacetate5EHL50I4MYIACT
TriethoxycaprylylsilaneLDC331P08EIACT
HYDROXYPROPYL BETADEX1I96OHX6EKIACT
Soybean Lecithin1DI56QDM62IACT
Anacystis NidulansUV4FTL6UAWIACT
HydroxyacetophenoneG1L3HT4CMHIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
TocopherolR0ZB2556P8IACT
Palmitoyl Tripeptide-38T7A529FB8OIACT

Source Document#

Source XML

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 Ageless Tinted Lightweight Emulsion SunscreenTITANIUM DIOXIDEISDIN Corp.293a1116-e8a2-495f-83db-20dd82ed13c22026-06-08WarningsExact identifier
ndc (package): 69494-022-03
ndc (package): 69494-022-04
ndc (package): 69494-022-02
ndc (package): 69494-022-01
ndc (product): 69494-022
ndc11 (package): 69494002204
ndc11 (package): 69494002202
ndc11 (package): 69494002201
ndc11 (package): 69494002203
spl id: b6653d42-038d-4dfd-9178-04ce549fed3f
spl set id: 293a1116-e8a2-495f-83db-20dd82ed13c2

Reported adverse events (FAERS/openFDA)#

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