Eryfotona®

Eryfotona®
SPL v7
SPL
SPL Set ID a58ac2ed-31b7-4a86-83ca-7630b0c9ea6f
Route
TOPICAL
Published
Effective Date 2026-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (107 mg)
Inactive Ingredients
Soybean Lecithin Disteardimonium Hectorite Citric Acid Monohydrate Dibutyl Adipate Butylene Glycol Sodium Chloride Panthenol Water Nylon-12 Peg-10 Dimethicone (600 Cst) Silicon Dioxide Glycerin Dimethicone Levomenol .alpha.-tocopherol Acetate Ethylhexylglycerin Edetate Disodium Anhydrous Propanediol Glyceryl Monostearate Tocopherol Ascorbyl Palmitate Alcohol Denatonium Benzoate Pentapeptide-34 Cyclomethicone 5 Diethylhexyl Carbonate Ascorbic Acid Ferric Oxide Red Ferrosoferric Oxide Ferric Oxide Yellow Cyclomethicone 6 Dicaprylyl Carbonate Phenoxyethanol Peg-30 Dipolyhydroxystearate (4000 Mw) Triethoxycaprylylsilane Palmitoyl Tripeptide-38 Polyethylene Glycol 400 Hydroxypropyl Betadex Pentapeptide-34 Trifluoroacetate Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-06-10

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9
  • Stop use and ask doctor if rash occurs.
Section 50567-7
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1
  • Do not use on damaged or broken skin.
Warning
  • For external use only.
Directions
  • 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.
Active Ingredient

Zinc Oxide 10.7%

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients

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?

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

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)


Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
  • Stop use and ask doctor if rash occurs.
Section 50567-7 (50567-7)
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin.
Purpose

Sunscreen

Warning
  • For external use only.
Directions
  • 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.
Active Ingredient (Active ingredient)

Zinc Oxide 10.7%

Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients (Inactive ingredients)

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? (Questions or comments?)

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 (PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton)

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)


Advanced Ingredient Data


Raw Label Data

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