Eryfotona Actinica Tinted Emulsion
FDA Label NDC 69494-020

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 Tinted (NDC 69494-020). 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, warnings, 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

Titanium Dioxide 16.1%

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

Warnings

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

Directions

  • 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

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

Inactive Ingredients

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, Butyloctyl Salicylate, Magnesium Sulfate, VP/Eicosene Copolymer, 1,2-Hexanediol, Caprylyl Glycol, Panthenol, Fragrance, Disteardimonium Hectorite, Tocopheryl Acetate, Dimethicone/Vinyl Dimethicone Crosspolymer, Propylene Carbonate, PEG-10 Dimethicone, Triethoxycaprylylsilane, Lecithin, Plankton Extract, Hydroxyacetophenone, Phenethyl Alcohol, Tocopherol

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
Actinica® Tinted

Lightweight Emulsion Sunscreen

BROAD SPECTRUM SPF 50

Designed for
Actinic Damage

100% MINERAL UV FILTER*
AND DNA REPAIRSOMES®

3.4 FL OZ (100 mL)

Principal Display Panel (100 mL Bottle Carton)

Principal Display Panel (100 mL Bottle Carton)

* Please review the disclaimer below.