Silken Pore Perfecting Sunscreen Broad Spectrum Spf 35 Lotion
FDA Label NDC 69417-150

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tatcha Inc. for the product Silken Pore Perfecting Sunscreen Broad Spectrum Spf 35 (NDC 69417-150). 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 drug facts, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Octisalate 5%

Zinc Oxide 15%

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.

Do not use on damaged or broken skin.

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

Stop use and ask a 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.
  • Reapply at least every 2 hours.
  • 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 a broad spectrum SPF 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.

Inactive Ingredients

WATER, ISODODECANE, CYCLOPENTASILOXANE, PROPANEDIOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, GLYCERIN, DIMETHICONE, OCTYLDODECYL NEOPENTANOATE, BEHENYL ALCOHOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ROSA MULTIFLORA FRUIT EXTRACT, ERIOBOTRYA JAPONICA LEAF EXTRACT, STEARYL GLYCYRRHETINATE, GLYCYRRHIZA INFLATA ROOT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, PISTACIA LENTISCUS (MASTIC) GUM, SERICIN, ALGAE EXTRACT, LECITHIN, INOSITOL, POLYHYDROXYSTEARIC ACID, SORBITAN TRISTEARATE, SODIUM DILAURAMIDOGLUTAMIDE LYSINE, SILICA, POTASSIUM SORBATE, BEHENETH-20, SODIUM ACRYLATE/ACRYLOYLDIMETHYLTAURATE/DIMETHYLACRYLAMIDE CROSSPOLYMER, POLYMETHYLSILSESQUIOXANE, METHICONE, TRIMETHYLSILOXYSILICATE, DIMETHICONOL, DISODIUM EDTA, FRAGRANCE, ETHYLHEXYLGLYCERIN, ALCOHOL, PHENOXYETHANOL, IRON OXIDES (CI77491), TIN OXIDE (CI 77861), MICA (CI 77019), TITANIUM DIOXIDE (CI 77891)

Questions?

Call toll free (888) 739-2932 ext. 1

Call toll free (877) 322-8633

Packaging

Silken-4 (69417150 4)

Silken-4 (69417150 4)

Silken-3 (69417150 3)

Silken-3 (69417150 3)

* Please review the disclaimer below.