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 193 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olay Total Effects Moisturizer Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEThe Procter & Gamble Manufacturing Company8de52cb2-b4d2-1e0d-e053-2995a90a5aca2025-08-19WarningsExact identifier
application number: M020
Sun Bum 30 Mineral Sunscreen Lip BalmZINC OXIDESun Bum, LLC3cbfba65-5702-50b5-e063-6394a90a409d2025-08-19WarningsExact identifier
application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Face Stick Tinted 50ZINC OXIDESun Bum, LLC324e8ddb-89d2-08ca-e063-6294a90ab6c12025-08-19WarningsExact identifier
application number: M020
Sun Bum 70 Premium SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b02811d-dc66-fc6f-e063-6294a90aefc82025-08-18WarningsExact identifier
application number: M020
Sun Bum Kids 50 Clear SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b058b74-27d0-8f8a-e063-6294a90aa02c2025-08-18WarningsExact identifier
application number: M020
PLAY Mineral Stick SPF 50 with Olive Fruit ExtractZINC OXIDESupergoop LLC3ca7e1ed-7cc7-76b0-e063-6394a90ade932025-08-18WarningsExact identifier
application number: M020
Sun Bum Mineral 30 Sunscreen 6 OZZINC OXIDESun Bum, LLC3b91a7e3-ce52-6aa0-e063-6394a90a15e72025-08-18WarningsExact identifier
application number: M020
CoTZ KidsZINC OXIDEFallien Cosmeceuticals, LTD.3ca8742f-67cb-a25c-e063-6394a90a46382025-08-18WarningsExact identifier
application number: M020
Sun Bum 30 Premium Moisturizing Sunscreen 8 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b154009-9c6f-eadf-e063-6394a90ae4242025-08-18WarningsExact identifier
application number: M020
Sun Bum Kids 50 Clear Sunscreen 6 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b162348-0222-490e-e063-6394a90ad4942025-08-18WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen 1.75 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b169860-66bc-dd02-e063-6294a90a79742025-08-18WarningsExact identifier
application number: M020
Sun Bum 30 Mineral Sunscreen Face 1.7 OZTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3b1729c5-d8ca-94c7-e063-6394a90a67a52025-08-18WarningsExact identifier
application number: M020
CoTZ KidsZINC OXIDEFallien Cosmeceuticals, LTD.3ca914e2-cd53-42bf-e063-6294a90a70822025-08-18WarningsExact identifier
application number: M020
Sun Bum Daily Mineral Sunscreen Moisturizer Broad Spectrum SPF 30ZINC OXIDESun Bum, LLC3b1a0596-b852-16be-e063-6394a90a34982025-08-18WarningsExact identifier
application number: M020
Sun Bum Signature Clear High Performance Sunscreen Broad Spectrum SPF 50 1.5 OZOCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3b29dbfc-0b92-eb0f-e063-6294a90a16e12025-08-18WarningsExact identifier
application number: M020
Sun Bum 30 Mineral Sunscreen 32 OZZINC OXIDESun Bum, LLC3b2cb7cf-7e2c-0fd2-e063-6294a90a3b172025-08-18WarningsExact identifier
application number: M020
Sun Bum Sunscreen Oil 50 5 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b2b4ba0-3f89-0a04-e063-6294a90ac1c02025-08-18WarningsExact identifier
application number: M020
Sun Bum Signature Sunscreen Premium Zinc Lip Balm Broad Spectrum SPF 30ZINC OXIDESun Bum, LLC3ca9e9d3-1c73-7bd6-e063-6394a90ad2042025-08-18WarningsExact identifier
application number: M020
Ocean Potion Suncare Mineral 50 Essential Scent of Sunshine Zinc Oxide Continuous SunscreenZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3caaea85-0dfe-6f69-e063-6294a90a7d4a2025-08-18WarningsExact identifier
application number: M020
PLAY Lip Shield SPF 30 - MintAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop LLC3cab1a7d-6226-9eba-e063-6294a90a8c4d2025-08-18WarningsExact 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