FDA.reportPublic FDA data

Silk Line Silk Day Cream SPF 15

Manufacturer
Exelencia Importers, Corp. | Biocosmetica Exel Argentina SRL
Effective date
2024-06-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:14:49

Label at a glance#

ProductSilk Line Silk Day Cream SPF 15
Active ingredientOCTOCRYLENE, OCTISALATE, OCTINOXATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Octinoxate(Ethylhexyl methoxycinnamate) 7.5% Sunscreen

Octocrylene 7.0% Sunscreen

Octisalate (Ethylhexyl salicylate) 2.0 Sunscreen

OTC - PURPOSE SECTION

Uses

Helps prevent sunburn

Higher SPF gives more sunburn protection

If used as directed with other sun-protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by de sun

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not use in children. Keep out of reach of children.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Apply and massage with a gentle circular motion in face and neck until completely absorbed 15 minutes before sun exposure.
Reapply at least every 2 hours after towel drying, swimming or perspiring.
Sun protection measures: spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher or other sun protection measures including:
Limit time in the sun, especially between 10am-2pm
Wear long sleeved shirts, pants, hats and sunglasses
Use a water resistant sunscreen if swimming or sweating.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Purified Water (aqua), Cyclopentasiloxane, Glycerin1, Glyceryl Stearate SE, Caprylic/Capric Triglyceride, Cyclomethicone, Dimethiconol, Hydrolyzed Silk, Ceteraryl Alcohol, Ceteareth-20, Yeast Extract, Sodium DNA, Aloe Barbadensis Leaf Extract, Panthenol, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Imidazolinyl Urea, Butyrospermum Parkii Butter, Phenoxyethanol, Bisabolol, Tocopheryl Acetate, Calcium Disodium EDTA, DM DM Hydantoin, Polysorbate 20, Methylparaben, Fragrance (parfum), BHT, Propylparaben, Sodium Hyaluronate, Betacarotene

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Exel

Silk Line

Silk Day Cream SPF 15

with hydrolyzed silk proteins

Linea Seda

Crema De Dia FPS 15

Con hydrolizado de proteinas de seda

Biocosmetica Proffesional

1,69 fl Oz 50 ml

PA-0610-005-Cl-1020PA-0610-005-Cl-1020

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53863-00353863-003-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
SHEA BUTTERK49155WL9YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CYCLOMETHICONE 50THT5PCI0RIACT
WATER059QF0KO0RIACT
LEVOMENOL24WE03BX2TIACT
PROPYLPARABENZ8IX2SC1OHIACT
BETA CAROTENE01YAE03M7JIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ALOE VERA LEAFZY81Z83H0XIACT
PANTHENOLWV9CM0O67ZIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
XANTHAN GUMTTV12P4NEEIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DIMETHICONOL (40 CST)343C7U75XWIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
CYCLOMETHICONENMQ347994ZIACT
METHYLPARABENA2I8C7HI9TIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
IMIDUREAM629807ATLIACT
DMDM HYDANTOINBYR0546TOWIACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
EDETATE CALCIUM DISODIUM ANHYDROUS8U5D034955IACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
OCTINOXATE4Y5P7MUD51ACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Silk Line Silk Day Cream SPF 15OCTINOXATE, OCTOCRYLENE, OCTISALATEExelencia Importers, Corp.b2d35086-748b-55d0-e053-2995a90a18982024-06-30WarningsExact identifier
ndc (package): 53863-003-01
ndc (product): 53863-003
ndc11 (package): 53863000301
spl id: 1c24d391-a0a8-85a4-e063-6294a90a51b0
spl set id: b2d35086-748b-55d0-e053-2995a90a1898

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.