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 234 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Protect Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDENEW SEASON DERMATOLOGY, PLLCfecd72a3-c7e5-3dfa-e053-6394a90a73572025-01-09WarningsExact identifier
application number: M020
ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L41b3cf18-dc11-4e1d-802e-5ba25bd87adb2025-01-09WarningsExact identifier
application number: M020
ECLIPSE SPF 50 PERFECTINT BEIGETITANIUM DIOXIDE, ZINC OXIDESCIENCE OF SKINCARE LLCb69dda25-372f-15d9-e053-2995a90a8d3e2025-01-09WarningsExact identifier
application number: M020
PerfecTint Powder SPF 40 All ShadesZINC OXIDEScience of Skincarebb26c010-299e-3dc5-e053-2995a90a2c892025-01-09WarningsExact identifier
application number: M020
Extreme Protect SPF 40 All ShadesZINC OXIDE, TITANIUM DIOXIDEScience of Skincare, LLC.b69db78b-5f0e-8ca2-e053-2a95a90ac88c2025-01-09WarningsExact identifier
application number: M020
ECLIPSE SPF 50 ALL SHADESTITANIUM DIOXIDE, ZINC OXIDESCIENCE OF SKINCARE LLC49df51e6-be9a-41be-b3e1-bfc062aaceaa2025-01-09WarningsExact identifier
application number: M020
CoTZ Mineral Suns Stick - Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD44a6ff9b-8067-4f32-acb2-4ede54c79e6e2025-01-09WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - SUNKISSEDZINC OXIDE SUNSCREENBentley Laboratories, LLCc45b59d8-0196-4dce-bfaa-57c47f655fe82025-01-09WarningsExact identifier
application number: M020
TiZO Tinted Lip Protection SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a22025-01-09WarningsExact identifier
application number: M020
CoTZ Face Prime and Protect SPF 40 (Tinted)TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1088fbf6-5790-490d-b272-ec281b4b76fa2025-01-09WarningsExact identifier
application number: M020
CoTZ Face Prime and Protect SPF 40 (Non-Tinted)TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDf106f52b-2157-46c7-9f7c-50f43a6490502025-01-09WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - SUNNY SWEET CHEEKSZINC OXIDE SUNSCREENBentley Laboratories, LLC5c98bacb-8bbd-47b8-8987-50be1ed34fc02025-01-09WarningsExact identifier
application number: M020
CoTZ Face MoistureZINC OXIDEFallien Cosmeceuticals, LTDdb682516-6c8f-4009-a9ec-e21dfc64ce152025-01-09WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Light MediumOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beautybcd22c9a-2db6-4653-9ab5-825f3f5cc4202025-01-08WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 LightOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beautyc66c2a54-97c8-4904-a44a-b3cf790837f52025-01-08WarningsExact identifier
application number: M020
Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATETempo Industries, Inc.af9aa56d-2f8a-55b9-e053-2a95a90a32582025-01-08WarningsExact identifier
application number: M020
Baby Mineral Sunscreen Probiotics SPF55ZINC OXIDEHello Bello0191b2e4-bcc5-541a-e063-6294a90a0e782025-01-08WarningsExact identifier
application number: M020
Kids Face and Body Sunscreen SPF 50ZINC OXIDEHello Bello01cc4ea0-e3de-32f1-e063-6394a90a13752025-01-08WarningsExact identifier
application number: M020
Baby Mineral Sunscreen SPF55ZINC OXIDEHello Bello0190eeaf-c5a0-3253-e063-6294a90a43c42025-01-08WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 50ZINC OXIDEHello Bello01cc205b-a345-262a-e063-6394a90a955c2025-01-08WarningsExact 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