Silken Pore Perfecting Sunscreen Broad Spectrum Spf 35
FDA Label NDC 69417-110

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 69417-110). 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 active ingredients, uses, warnings, directions, inactive ingredients, other information, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Octisalate 5.00%

Zinc Oxide 15.00%

Uses

  • Helps prevens sunburn
  • If used as direced with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin again caused by the sun.

Warnings

When using this product • keep out of eyes • rinse with water to remove • do not use on damaged or broken skin

Stop use and ask a docor • if rash occurs

Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

For external use only

Directions

  • Apply liberally 15 minutes before sun exposure
  • Use water resistant sunscreen if swimming or sweathing
  • Reapply at least every 2 hours
  • Children under 6 months: ask a doctor
  • Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun especially from 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.

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 (LICORICE EXTRACT), GLYCYRRHIZA INFLATA (LICORICE) ROOT EXTRACT, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, PISTACIA LENTISCUS (MASTIC) GUM, SERICIN (SILK EXTRACT), ALGAE EXTRACT, LECITHIN, INOSITOL (RICE EXTRACT), POLYHYDROXYSTEARIC ACID, SORBITAN TRISTEARATE, SODIUM DILAURAMIDOGLUTAMIDE LYSINE, SILICA, POTASSIUM SORBATE, BEHENETH-20, SODIUM ACRYLATE/ACRYLOYLDIMETHYLTAURATE/DIMETHYLACRYLAMIDE CROSSPOLYMER, POLYMETHYLSILSESQUIOXANE, TITANIUM DIOXIDE, METHICONE, TRIMETHYLSILOXYSILICATE, DIMETHICONOL, DISODIUM EDTA, IRON OXIDES (CI77491), TIN OXIDE, MICA, FRAGRANCE (NATURAL), ETHYLHEXYLGLYCERIN, ALCOHOL, PHENOXYETHANOL.

Other Information

  • Protect this product form excessive heat and direct sun.

* Please review the disclaimer below.