FDA.reportPublic FDA data

Silk Line Silk Day Cream SPF 15

Product NDC
53863-003
11-digit product format
538630003
Labeler code
53863
Product ID
53863-003_1c24d391-a0a8-85a4-e063-6294a90a51b0
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octocrylene, Octisalate
Dosage form
CREAM
Route
TOPICAL
Labeler
Exelencia Importers, Corp.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-26
Substance
OCTOCRYLENE; OCTISALATE; OCTINOXATE
Active strength
7; 2; 7.5 g/100mL; 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
Silk Line Silk Day Cream SPF 15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE7 g/100mL
OCTISALATE2 g/100mL
OCTINOXATE7.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b2d35086-748b-55d0-e053-2995a90a1898Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53863-003-012023-04-12C16284748780-1f386c649-c65b-0266-e053-dadaa90a7c1aSilk Line Silk Day Cream SPF 15
53863-003-012023-01-30C16284748780-1f386c649-c65b-0266-e053-dadaa90a7c1aSilk Line Silk Day Cream SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53863-003-01Silk Line Silk Day Cream SPF 1550 mL in 1 BOXCREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53863-003SILK LINE SILK DAY CREAM SPF 15 (OCTINOXATE, OCTOCRYLENE, OCTISALATE) CREAM [EXELENCIA IMPORTERS, CORP.]3Current NDC, Legacy NDC, 1 package rows20240708_b2d35086-748b-55d0-e053-2995a90a1898.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 328 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. C. Tuna Resurface Essential Day CreamHOMOSALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONEFarmasi US LLCb92ff1e9-9dc4-46cb-a99d-98ff15bffc792023-11-05WarningsExact identifier
application number: M020
Dr C Tuna Sun protector lip balm SPF 15HOMOSALATE, OCTINOXATEFarmasi US LLCddcd82b5-9ad2-2340-e053-2a95a90a4fc02023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 04 Medium to TanTITANIUM DIOXIDEFarmasi US LLCdeee5784-c68b-4cd7-acbf-f64391a01bfc2023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 02 Light to MediumTITANIUM DIOXIDEFarmasi US LLCcef1a926-b7d4-47d6-957d-e3092e60970c2023-11-05WarningsExact identifier
application number: M020
Dr. C. Tuna Lumi Radiance Brightening CreamOCTOCRYLENE, OCTINOXATE, AVOBENZONEFarmasi US LLCb55790f7-20f2-404e-9a0e-5e76c383bf752023-11-05WarningsExact identifier
application number: M020
Dr. C. Tuna Lumi Radiance Brightening Cream 22 SPFOCTOCRYLENE, OCTINOXATE, AVOBENZONEFarmasi US LLCde493e30-d10e-9def-e053-2995a90ae49a2023-11-05WarningsExact identifier
application number: M020
Dr. C. Tuna Sun Face and Body SPF 50AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATEFarmasi US LLC141f9d22-deb7-4b6b-97b5-ee21898b96f72023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 06 DeepTITANIUM DIOXIDEFarmasi US LLC2f13a160-740f-4b09-8858-e438a9ba303e2023-11-05WarningsExact identifier
application number: M020
Dr. C. Tuna Sun Bronzing Oil SPF 6OCTINOXATEFarmasi US LLC91b428cc-1c80-4d56-8450-790c66de41332023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 05 TanTITANIUM DIOXIDEFarmasi US LLC3f494921-844e-4010-ab0c-144c8dce8aca2023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25TITANIUM DIOXIDEFarmasi US LLCf4fcfc78-9591-4a20-b9fb-88e1dc9b221d2023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 02 Light to MediumTITANIUM DIOXIDEFarmasi US LLC0d913242-2e57-4ba7-a718-154af68480b22023-11-05WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 03 MediumTITANIUM DIOXIDEFarmasi US LLC6ef986df-4044-4c32-8b64-f8110c9c95432023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 04 Medium to TanTITANIUM DIOXIDEFarmasi US LLCde24317f-2cf0-4125-bb17-c3d6b3c22e002023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 05 TanTITANIUM DIOXIDEFarmasi US LLC22842793-ae1f-4b71-8db9-34c06dc37daa2023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 03 MediumTITANIUM DIOXIDEFarmasi US LLC9f203e7f-3bba-4f36-a35a-6d9466e390822023-11-05WarningsExact identifier
application number: M020
Farmasi CC Color Control Cream SPF 25- 06 DeepTITANIUM DIOXIDEFarmasi US LLCc28afa3b-9a8d-4e19-bc6b-39cc8428c9f92023-11-05WarningsExact identifier
application number: M020
DR. C Tuna Sunscreen 30 SPF Broad Spectrum Face and bodyAVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATETAN-ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETIa71ee8e0-2d27-7ae6-e053-2a95a90aecd42023-11-05WarningsExact identifier
application number: M020
PHARMACA Natural Mineral Sunscreen SPF-50TITANIUM DIOXIDE, ZINC OXIDEPharmaca Integrative Pharmacy, Inc.51e6cd7a-5c9a-4666-9021-ade42eb064cd2023-11-05WarningsExact identifier
application number: M020
Dr.C.Tuna Sun Face Cream SPF50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENETan Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret Anonim Sirketif668c078-61e6-2c81-e053-2a95a90a31002023-11-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53863-003-015386300030150 mL in 1 BOX (53863-003-01) 50 ml2020-10-260000-00-00NoNoCurrent