Eryfotona Ageless Tinted Mineral

Manufacturer
ISDIN Corp. | Laboratoris Feltor
Effective date
2022-08-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:54:41

Label at a glance#

ProductEryfotona Ageless Tinted Mineral
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

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. 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 ...

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 17%

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.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • 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

Propylene Glycol Dicaprylate/Dicaprate, Water, Dimethicone, C15-19 Alkane, Dicaprylyl Carbonate, Silica, Dibutyl Adipate, PEG-30 Dipolyhydroxystearate, VP/Eicosene Copolymer, Polyglyceryl-2 Dipolyhydroxystearate, Iron Oxides, Caprylic/Capric Triglyceride, Glycerin, Butyloctyl Salicylate, Magnesium Sulfate, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Panthenol, Disteardimonium Hectorite, Tocopheryl Acetate, Propanediol, Dimethicone/Vinyl Dimethicone Crosspolymer, Fragrance, Propylene Carbonate, PEG-10 Dimethicone, Tetrasodium Glutamate Diacetate, Triethoxycaprylylsilane, PEG-8, Carbomer, Tocopherol, Polysorbate 20, Sodium Lactate, Phenoxyethanol, Lecithin, Plankton Extract, Ascorbyl Palmitate, Sodium Benzoate, Ascorbic Acid, Citric Acid, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, 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
PHOTO

Eryfotona
Ageless
Tinted Mineral

BROAD SPECTRUM SUNSCREEN SPF 50

Photoaging Defense

DNA Repairsomes®
Peptide Blend
and Antioxidants
to help skin fight photoaging

3.4 FL OZ (100 mL)

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

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69494-00769494-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

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
9abd28c8-ceeb-420b-9be7-d32c59163997a847e5b5-9fde-4cc0-a2e6-2f7d06ae96f32023-02-17WarningsExact identifier
spl set id: a847e5b5-9fde-4cc0-a2e6-2f7d06ae96f3

Reported adverse events (FAERS/openFDA)#

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