FDA.reportPublic FDA data

SILKEN pore perfecting sunscreen broad spectrum SPF 35

Product NDC
69417-150
11-digit product format
694170150
Labeler code
69417
Product ID
69417-150_32193fc9-48a9-4d69-b700-5e0bf8b9c862
Type
HUMAN OTC DRUG
Nonproprietary name
Octisalate, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
TATCHA INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-26
Substance
OCTISALATE; ZINC OXIDE
Active strength
5; 15 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
SILKEN pore perfecting sunscreen broad spectrum SPF 35
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE5 g/100mL
ZINC OXIDE15 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
251566a1-0e21-4030-9d4e-52c4a8bd3330Available on FDA.report

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

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 142 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Sunscreen Dry Touch NTTITANIUM DIOXIDE, ZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC334ffc49-3196-0995-e063-6394a90ad5592025-12-09Exact identifier
application number: M020
Foam Weightless Sunscreen Non-Tinted Drytouch NTTITANIUM DIOXIDE, ZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC335ec22c-6a9a-c4d1-e063-6394a90ac0b02025-12-09Exact identifier
application number: M020
Mineral Sunscreen Moisturizing Non-TintedZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC3360a208-5f17-a74b-e063-6294a90a13e12025-12-09Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELily Lee, MD323356ea-31a0-6ff0-e063-6294a90a135c2025-12-09Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELily Lee, MD32330376-5db0-202b-e063-6294a90add152025-12-09Exact identifier
application number: M020
Sunscreen Plus UntintedZINC OXIDELily Lee, MD32354468-94a2-604b-e063-6394a90adfb52025-12-09Exact identifier
application number: M020
Sunscreen Plus TintedZINC OXIDELily Lee, MD32346536-f542-ef0f-e063-6394a90a04642025-12-09Exact identifier
application number: M020
Sunscreen Plus Mineral Stick UntintedTITANIUM DIOXIDE, ZINC OXIDELily Lee, MD3234b498-5b56-55f4-e063-6294a90a9b872025-12-09Exact identifier
application number: M020
Sunscreen Plus TintedZINC OXIDELily Lee, MD3235a696-92aa-788c-e063-6394a90a01492025-12-09Exact identifier
application number: M020
Sunscreen Plus Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDELily Lee, MD32351db0-884c-8fa0-e063-6294a90acba22025-12-09Exact identifier
application number: M020
Sunscreen Plus UntintedZINC OXIDELily Lee, MD3235786d-7ba9-c9ab-e063-6294a90a7f2e2025-12-09Exact identifier
application number: M020
Tinted Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC31416d04-2d6f-7cf9-e063-6294a90a98062025-12-09WarningsExact identifier
application number: M020
Matte Invisible Mineral Sunscreen Non-TintedZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC3143968a-096e-b9ac-e063-6294a90ada0d2025-12-09WarningsExact identifier
application number: M020
Daily Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC314299b1-a78b-c1bd-e063-6294a90ab43b2025-12-09WarningsExact identifier
application number: M020
Sheer Satin Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC3143d8b0-4af8-f52d-e063-6294a90a926b2025-12-09WarningsExact identifier
application number: M020
Matte Invisible Mineral SunscreenZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC3142ed0f-f379-f240-e063-6294a90a53032025-12-09WarningsExact identifier
application number: M020
Sheer Non-Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEFace Collection, L.L.C.33d83cfb-045d-141c-e063-6394a90a2e042025-12-09Exact identifier
application number: M020
First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company45875865-5e9c-d652-e063-6394a90ad5fa2025-12-09WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMaloney Plastic Surgery Skin Care, PLLC316b7584-c782-fe9e-e063-6394a90a76fe2025-12-09Exact identifier
application number: M020
Transparent Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEFace Collection, L.L.C.33dbfd9b-b90f-bb32-e063-6294a90af7dc2025-12-09Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69417-150-03694170150031 TUBE in 1 CARTON (69417-150-03) / 10 mL in 1 TUBE1 tube2023-04-26NoNoCurrent
69417-150-04694170150041 TUBE in 1 CARTON (69417-150-04) / 90 mL in 1 TUBE1 tube2025-04-18NoNoCurrent
69417-150-20694170150201 TUBE in 1 CARTON (69417-150-20) / 60 mL in 1 TUBE1 tube2023-04-26NoNoCurrent