FDA.reportPublic FDA data

SILKEN pore perfecting sunscreen broad spectrum SPF 35

Manufacturer
TATCHA INC.
Effective date
2025-04-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:59:34

Label at a glance#

ProductSILKEN pore perfecting sunscreen broad spectrum SPF 35
Active ingredientOCTISALATE, ZINC OXIDE
Label structure10 sections

Indications and 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.

Dosage and administration

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,...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octisalate 5%

Zinc Oxide 15%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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 SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

Call toll free (877) 322-8633

SPL UNCLASSIFIED SECTION

PA +++

A weightless sunscreen that protects against UVA/UVB rays with SPF 35 and reduces the look of pores for a smooth, matte finish.

Formulated without parabens, synthetic fragrances, mineral oil, sulfate detergents, phthalates, urea, DEA or TEA.

Non-comedogenic.

Non-irritating.

Non-sensitizing.

Dermatologist tested.

FORMULATED IN JAPAN

MADE IN USA OF GLOBAL INGREDIENTS

DIST. TATCHA LLC

SAN FRANCISCO, CA 94123 USA

UK: DELPHIC HSE GU14 7NA

NL: 104 SCHIPHOL, 1118CN

© 2023 TATCHA LLC

QUESTIONS@TATCHA.COM

BEAUTIFUL FACES, BEAUTIFUL FUTURES

Your purchase supports education equality

www.tatcha.com/giving-back

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Silken-4Silken-4

Silken-3Silken-3

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SILKENPORE-90SILKENPORE-90

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69417-150-03SILKEN pore perfecting sunscreen broad spectrum SPF 351 in 1 CARTONLOTION13
69417-150-03SILKEN pore perfecting sunscreen broad spectrum SPF 3510 mL in 1 TUBELOTION103
69417-150-04SILKEN pore perfecting sunscreen broad spectrum SPF 351 in 1 CARTONLOTION13
69417-150-04SILKEN pore perfecting sunscreen broad spectrum SPF 3590 mL in 1 TUBELOTION903
69417-150-20SILKEN pore perfecting sunscreen broad spectrum SPF 351 in 1 CARTONLOTION13
69417-150-20SILKEN pore perfecting sunscreen broad spectrum SPF 3560 mL in 1 TUBELOTION603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69417-150SILKEN PORE PERFECTING SUNSCREEN BROAD SPECTRUM SPF 35 (OCTISALATE, ZINC OXIDE) LOTION [TATCHA INC.]3Current NDC, 6 package rows20250425_251566a1-0e21-4030-9d4e-52c4a8bd3330.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69417-15069417-150-03, 69417-150-20, 69417-150-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
ISODODECANEA8289P68Y2IACT
CYCLOMETHICONE 50THT5PCI0RIACT
PROPANEDIOL5965N8W85TIACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ROSA MULTIFLORA FRUITEZ5DSL4T27IACT
ERIOBOTRYA JAPONICA LEAFZ02066SV11IACT
STEARYL GLYCYRRHETINATE3YYE6VJS0PIACT
GLYCYRRHIZA INFLATA ROOT1MV1Z7MKVQIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
PISTACIA LENTISCUS RESIN7446H202QWIACT
SILK SERICIN0N1VMU8G9WIACT
SOYBEAN LECITHIN1DI56QDM62IACT
INOSITOL4L6452S749IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SORBITAN TRISTEARATE6LUM696811IACT
SODIUM DILAURAMIDOGLUTAMIDE LYSINEMNJ7VPT2R5IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
BEHENETH-20BJ4GP2IFLNIACT
METHICONE (20 CST)6777U11MKTIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALCOHOL3K9958V90MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FERRIC OXIDE RED1K09F3G675IACT
STANNIC OXIDEKM7N50LOS6IACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SILKEN pore perfecting sunscreen broad spectrum SPF 35OCTISALATE, ZINC OXIDETATCHA INC.251566a1-0e21-4030-9d4e-52c4a8bd33302025-04-16WarningsExact identifier
ndc (package): 69417-150-03
ndc (package): 69417-150-20
ndc (package): 69417-150-04
ndc (product): 69417-150
ndc11 (package): 69417015003
ndc11 (package): 69417015004
ndc11 (package): 69417015020
spl id: 32193fc9-48a9-4d69-b700-5e0bf8b9c862
spl set id: 251566a1-0e21-4030-9d4e-52c4a8bd3330

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.