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 329 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr.C.Tuna Sun Body SPF50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENETan Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret Anonim Sirketi250d8b0c-729b-4a0d-b6b0-2c9fdbc661972023-11-05WarningsExact identifier
application number: M020
Farmasi BBAVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI042817f9-675e-056a-e063-6394a90a2d972023-11-05WarningsExact identifier
application number: M020
JACKET SPF 50ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATEBalshi MD Dermaceuticalsb82b8a46-8009-416e-8718-296a231069142023-11-05WarningsExact identifier
application number: M020
SEA STAR SPARKLE SPF 50 Glitter Sunscreen Cotton CandyHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEMJ Products Association, LLC6ccd648f-ec3b-4325-8d89-b5dd10c2fff72023-11-05WarningsExact identifier
application number: M020
SEA STAR SPARKLE SPF 50 Glitter Sunscreen Cotton CandyHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEMJ Products Association, LLC43c84cab-e35b-4808-bcc5-399573aef3b42023-11-05WarningsExact identifier
application number: M020
NO BS Moisturizer SPF20OCTINOXATE, OCTISALATE, AVOBENZONEProduct Management, LLC142f3610-85da-408d-8fa5-3773167ffc9f2023-11-05WarningsExact identifier
application number: M020
SEA STAR SPARKLE SPF 50 Glitter Sunscreen Coco LimeHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEMJ Products Association, LLC63b252c4-7d02-475b-97aa-57ef9c2e52ad2023-11-05WarningsExact identifier
application number: M020
SEA STAR SPARKLE SPF 50 Glitter Sunscreen Coco LimeHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEMJ Products Association, LLC533b6106-7f6f-49b9-9670-e2050bfcb9322023-11-05WarningsExact identifier
application number: M020
VERTRA Premium Suncare SPF 30TITANIUM DIOXIDE, ZINC OXIDEEai-Jr286, Inc.720ca725-24ca-4b59-b640-afa9832386922023-11-05WarningsExact identifier
application number: M020
BEACH GYPSY Glitter Sunscreen SPF 30OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEMJ Products Association, LLC1d224ecf-d356-424e-b181-ad8692f82b032023-11-05WarningsExact identifier
application number: M020
BEAST HYDRATING FACE SPF-20OCTOCRYLENE, OCTISALATE, AVOBENZONESmall Batch Beauty, LLC37941628-9f4f-474e-a8d9-080f4c6631122023-11-05WarningsExact identifier
application number: M020
NAELI Day Moisturizer SPF 30OCTISALATE, OCTOCRYLENE, AVOBENZONEAlli LLC9fe2f5c4-cf20-207e-e053-2a95a90ac54f2023-11-05WarningsExact identifier
application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1COCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4c9ffd30-4799-475d-94cb-07ce3d5b36602023-11-04WarningsExact identifier
application number: M020
enfuselle BODY SUNSCREEN BROAD SPECTRUM SPF 30HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENEShaklee Corporationc57bfab7-f67c-435b-8703-e2051cfd097e2023-11-03WarningsExact identifier
application number: M020
Youth 2 Activating BB Cream SPF 30 Light MediumZINC OXIDE, TITANIUM DIOXIDEShaklee Corporatione51e38c9-cc9b-4af3-842d-41d0162f17ff2023-11-03WarningsExact identifier
application number: M020
Youth 4 Activating BB Cream SPF 30 DarkZINC OXIDE, TITANIUM DIOXIDEShaklee Corporation63f7f8bd-02f0-4a13-bb1e-298754b24fce2023-11-03WarningsExact identifier
application number: M020
Youth 1 Activating BB Cream SPF 30 LightZINC OXIDE, TITANIUM DIOXIDEShaklee Corporationc9e05055-48ea-405d-b1d4-50b263d0dbf92023-11-03WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Diorfe03fc14-4132-4dab-b013-d490764be0d42023-11-03WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior968cfae7-89b6-4ef3-ab60-1c675b90c1512023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 1NENSULIZOLE, OCTISALATEParfums Christian Diord2ca01ad-68b2-4312-a9d0-04d3e992bb132023-11-03WarningsExact 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