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 309 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Anthelios Dermo Kids Gentle Face and Body Broad Spectrum SPF 60 Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incf296e5ef-728a-4d57-8d65-7d88b1f90f882023-12-31WarningsExact identifier
application number: M020
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Face Lightweight, non-greasy feel 3 essential ceramides niacinamide MineralTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incbcf5e724-b40a-49dd-8a09-57cefd7f65ad2023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios UV Correct Broad Spectrum SPF 70 Daily SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inca7c01228-02db-49a8-bb91-cee13fbd1df12023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Ultra Light Sunscreen Broad Spectrum SPF 60 Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc202d8dda-b425-498f-aa82-1470c0cf0c232023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Face and Body Cooling Water Broad Spectrum SPF 60 Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Ince72ae48f-e4ec-458b-ae2b-bd6cb98552f92023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Pigmentclar Daily Dark Spot Correcting Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc197ea8bf-0d84-42cb-bf29-087ad95878772023-12-31WarningsExact identifier
application number: M020
CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 SunscreenHOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENEL'Oreal USA Products, Inc.2138f86b-3937-4c2b-9568-d40a745b637d2023-12-31WarningsExact identifier
application number: M020
La Roche Posay Face Body Anthelios SPF 60 Melt In Milk Fast absorbing, velvety finish for all skin types with Cell-OC Shield XLAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc533e6623-108e-4d05-8527-c5af643f08002023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Hydraphase UV Intense 24 Hour Hydrating Moisturizer Broad Spectrum SPF 20 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Production2f90f046-080b-4033-97b0-245fcc0f36832023-12-31WarningsExact identifier
application number: M020
CeraVe Developed with Dermatologists Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDEL'Oreal USA Products Inc27d82e37-67ac-4cd3-83c0-fb8388d3a0dd2023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 30 Cooling Water Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Incd7bf3928-85b8-4e5f-a04a-d520130a33402023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios AOX Daily Antioxidant Serum Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Incdc1a1b9f-fcc1-45bc-89e7-169bf240663d2023-12-31WarningsExact identifier
application number: M020
CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8e94e203-d3cf-45a1-88f9-6999f0aab22b2023-12-31WarningsExact identifier
application number: M020
Lancome Paris Absolue Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishing TreatmentAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc30cb2f12-1ebe-4850-be16-17748f0ba6702023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Ultra Facial Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc74ea4031-bb23-4028-ae32-78213646f66c2023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Facial Fuel Daily Energizing Moisture Treatment for Men Broad Spectrum SPF 20 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incdd6134f8-e2e0-49bf-bfec-ab04bfa5678b2023-12-30WarningsExact identifier
application number: M020
it cosmetics Bye Bye Foundation Full Coverage Moisturizer Oil Free Matte Broad Spectrum 50 Plus SunscreenTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC3d9ed59f-f280-4cc2-a0f1-4180deb5b7922023-12-30WarningsExact identifier
application number: M020
IT Cosmetics Your Skin But Better CC Plus Nude Glow Color Correcting Medium Coverage Skin Tint Brightening Glow Serum Broad Spectrum SPF 40 Sunscreen All ShadesHOMOSALATE, OCTISALATE AND OCTOCRYLENEIT COSMETICS, LLC2bdc6c73-d3e7-4a23-89dd-e4ffe44c034b2023-12-30WarningsExact identifier
application number: M020
Lancome Paris High Resolution Refill 3X Triple Action Renewal Anti Wrinkle Broad Spectrum SPF 15 SunscreenAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc02c51b56-e39a-4b3b-88c6-b7dc9c165f7e2023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inceb43177e-389d-4572-8521-ee4d0a2dad3a2023-12-30WarningsExact 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