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 315 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERIOUS SKINCARE SERIOUS C3 PLASMA BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONEFlageoli Limited4d11cc46-3942-1561-e054-00144ff8d46c2023-12-12WarningsExact identifier
application number: M020
ACTIVE ARGAN 365 SPF 30 BROAD SPECTRUM ACTIVATED ARGAN COMPLEXZINC OXIDESIBORG LLC9c4897f8-8fcb-4a0f-b42e-f582e2934f022023-12-12WarningsExact identifier
application number: M020
Byoma Moisturizing Gel Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEENGLEWOOD LAB, INC.f63fe60f-9863-1dfb-e053-2a95a90a90a52023-12-12WarningsExact identifier
application number: M020
MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant 80 MinTITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.5742da4b-6713-4de9-8ab8-b2bf2983371a2023-12-12WarningsExact identifier
application number: M020
restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea ComplexZINC OXIDERESTORSEA INC80ed7b28-16e0-4c9a-8e36-9d32ca3ddb9a2023-12-12WarningsExact identifier
application number: M020
ReVive Fermitif Neck Renewal SPF 15AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONEGurwitch Products, LLCde54d4ff-f9b4-4a12-95ea-fc2b61bee1c32023-12-12Exact identifier
application number: M020
Laura Mercier Flawless Skin Daily Face Shield SPF 40OCTINOXATE, TITANIUM DIOXIDEGurwitch Products, LLCf86729cd-682f-47b2-9bfa-1113721bfec02023-12-12WarningsExact identifier
application number: M020
Boscia BB SPF 27 PATITANIUM DIOXIDEBoscia LLC5dc86c0b-c340-4643-a174-a6b4c0826ca92023-12-12WarningsExact identifier
application number: M020
Dr.Denese SPF 30 Defense DayZINC OXIDE, OCTINOXATESkinScience Labs, Inc511dd97b-0f83-4ce9-8bfd-fa385f0dc8aa2023-12-12WarningsExact identifier
application number: M020
Boscia Daily Hydration SPF 15 Broad Spectrum For Normal To Oily SkinAVOBENZONE, OCTINOXATEBoscia LLC0c987cb9-7049-44b9-9935-647b0411a7342023-12-12WarningsExact identifier
application number: M020
Boscia BB Broad Spectrum SPF 27 PA Self Adjusting ShadeTITANIUM DIOXIDE, ZINC OXIDEBoscia LLC82a23aab-404f-46bb-afaa-8ba9b9bdbefd2023-12-12WarningsExact identifier
application number: M020
Boscia Restorative Day Moisture Broad Spectrum SPF 15 For Dry SkinAVOBENZONE, OCTINOXATEBoscia LLC657b04c6-d15b-470b-92e6-e59ed7e8b1162023-12-12WarningsExact identifier
application number: M020
Cellular Laboratories De-Aging Sunscreen Broad Spectrum SPF 50 PlusHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENEMarket Americac1898e00-05f1-4e28-9fa8-8cda1b1785952023-12-12WarningsExact identifier
application number: M020
Boscia BB BRONZE Broad Spectrum SPF 27 PA Self-Adjusting ShadeTITANIUM DIOXIDE, ZINC OXIDEBoscia LLC5f5fb9f5-00be-420a-b19a-b753c45f9a882023-12-12WarningsExact identifier
application number: M020
Boscia Self-Defense Vital Antioxidant Moisture Broad Spectrum SPF 30AVOBENZONE, OCTINOXATEBoscia LLC7d948951-598a-4a38-94a2-d357ee7f4d1e2023-12-12WarningsExact identifier
application number: M020
Restorative Day Moisture SPF 15OCTINOXATE, AVOBENZONEBoscia LLC01f17133-7f29-4f8e-a52c-c4466e4abefc2023-12-12WarningsExact identifier
application number: M020
3LAB Aqua BB SPF 40 BROAD SPECTRUM 03TITANIUM DIOXIDE3LAB, Inc.8a42a9d8-b9c6-45fb-8264-15f36e2765f02023-12-12WarningsExact identifier
application number: M020
3LAB Hydra Day SPF 20 Broad Spectrum Water-Based SunscreenOCTINOXATE, OCTISALATE, AVOBENZONE3LAB, Incd539b851-c4b2-40a2-9562-e3a95a86b7442023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT Lite Sunscreen SPF 30 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDE3LAB, Inc3052af3f-8923-47bc-be6e-17396275363a2023-12-12WarningsExact identifier
application number: M020
Isa SunGuard SPF 30ZINC OXIDE, TITANIUM DIOXIDEIsagenix International, LLCabe1e345-6ea2-43b3-8613-b5b5e04c87b72023-12-12WarningsExact 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