Eryfotona Actinica Ultralight Emulsion
FDA Label NDC 69494-302

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Isdin Corp for the product Eryfotona Actinica Ultralight Emulsion (NDC 69494-302). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warning, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Zinc Oxide 11%

Purpose

Sunscreen

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

Warning

  • For external use only.

Otc - Do Not Use

  • Do not use on damaged or broken skin

Otc - When Using

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

Otc - Stop Use

  • Stop use and ask doctor if rash occurs

Otc - Keep Out Of Reach Of Children

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

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.

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, PEG-30 Dipolyhydroxystearate, Nylon-12, PEG-10 Dimethicone, Dimethicone, Sodium Chloride, Phenoxyethanol, Disteardimonium Hectorite, Triethoxycaprylylsilane, Tocopheryl Acetate, Glyceryl Stearate, Fragrance, Bisabolol, Disodium EDTA, Ethylhexylglycerin, Panthenol, PEG-8, Tocopherol, Lecithin, Plankton Extract, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid.

Questions Or Comments?

Call (862) 242-8129
Monday – Friday
(9 a.m. to 5 p.m. EST)
or visit www.isdin/us
USA Patent Pending

Principal Display Panel - 100 Ml Bottle Carton

ISDIN
PHOTO

Eryfotona
Actinica®

Ultralight Emulsion

BROAD SPECTRUM SPF 50+

Designed for
Actinic Damage

Sunscreen with
DNA Repairsomes™
and antioxidants.

Water resistant
(40 minutes)

100% MINERAL
SUNSCREEN

3.4 FL OZ (100 mL)

Principal Display Panel (100 mL Bottle Carton)

Principal Display Panel (100 mL Bottle Carton)

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