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 283 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens SPF 50 Mineral SunscreenZINC OXIDEWALGREEN COMPANYd50787f1-0c50-d153-e053-2995a90add1e2024-10-14WarningsExact identifier
application number: M020
Walgreens SPF55 Sunscreen Reef-Conscious FormulaAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYcfd7c1b0-cfc3-074f-e053-2995a90a5edb2024-10-14WarningsExact identifier
application number: M020
Well at Walgreens Mist Sheer Broad Spectrum Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEWALGREEN COMPANYdfc64c7b-ee59-62a3-e053-2995a90a14a12024-10-14WarningsExact identifier
application number: M020
WALGREENS SPORT CONTINUOUS SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYe4b84304-6053-0cfe-e053-2a95a90a124a2024-10-14WarningsExact identifier
application number: M020
Walgreens 50 Baby Mineral SunscreenZINC OXIDEWALGREEN COMPANYdbee6094-e105-6d14-e053-2995a90a15282024-10-14WarningsExact identifier
application number: M020
Target Up and Up SPF55 Sunscreen Reef-Conscious FormulaAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATIONcfd6dd4c-21f6-7cef-e053-2a95a90a50e22024-10-14WarningsExact identifier
application number: M020
Target Up and Up SPF50 Sport Sunscreen Lip Balm Reef-Conscious FormulaAVOBENZONE, HOMOSALATE, OCTOCRYLENETARGET CORPORATIONf8c100bd-9230-813b-e053-6294a90ae0062024-10-14WarningsExact identifier
application number: M020
Target Up and Up Mineral Sunscreen Broad Spectrum SPF 50 Reef-Conscious FormulaTITANIUM DIOXIDE, ZINC OXIDETARGET CORPORATIONcfd735d2-df3a-5ed0-e053-2995a90a9f262024-10-14WarningsExact identifier
application number: M020
Target Goodfellow and Co SPF 30 Face Scent No. 05 Kelp and Sea MineralAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATIONf98ee294-3ca5-18bd-e053-6394a90a9aa52024-10-14WarningsExact identifier
application number: M020
Target Up and Up Oil Free Facial Moisturizer with Sunscreen Broad Spectrum SPF 15AVOBENZONE, OCTISALATE, OCTOCRYLENETARGET CORPORATIONf9027e42-017a-07fd-e053-6294a90ab9162024-10-14WarningsExact identifier
application number: M020
Target Up and Up SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETARGET CORPORATIONf99028fa-a17e-4a84-e053-6294a90a927f2024-10-14WarningsExact identifier
application number: M020
Up and Up Illuminating Daily Moisturizer with Sunscreen Broad Spectrum SPF 15AVOBENZONE, OCTINOXATE, OCTISALATETARGET CORPORATION9407a4a9-8a72-6a01-e053-2a95a90a231d2024-10-14WarningsExact identifier
application number: M020
Target Up and Up Morning Facial Moisturizing with Sunscreen Broad Spectrum SPF 30HOMOSALATE, OCTOCRYLENE, ZINC OXIDETARGET CORPORATIONf9b66e3e-5493-9ea4-e053-6294a90a60632024-10-14WarningsExact identifier
application number: M020
SIGNATURE CARE SPORT SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESAFEWAY, INC.a6296612-184c-6b3c-e053-2a95a90a34b92024-10-14WarningsExact identifier
application number: M020
OPEN NATURE SPF 50 MINERAL SUNSCREENZINC OXIDESAFEWAY, INC.a6020d2f-55c4-adfc-e053-2a95a90ad2382024-10-14WarningsExact identifier
application number: M020
OPEN NATURE CHILDREN SPF 50 MINERAL SUNSCREENZINC OXIDESAFEWAY, INC.a6044f0f-eb86-684d-e053-2995a90a09212024-10-14WarningsExact identifier
application number: M020
SIGNATURE CARE SPORT SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESAFEWAY, INC.a62848fb-7016-3457-e053-2a95a90aa0f12024-10-14WarningsExact identifier
application number: M020
Safeway Signature Care Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENESafeway, Inc.c6a0ae3e-d68a-b838-e053-2a95a90a77f72024-10-14WarningsExact identifier
application number: M020
SIGNATURE CARE SPORT SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESAFEWAY, INC.a628ff71-463d-4d39-e053-2995a90a7a422024-10-14WarningsExact identifier
application number: M020
CVS Health SPF 70 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONESafeway, Inc.c5106c63-af51-c169-e053-2a95a90afef22024-10-14WarningsExact 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