NDC 53863-003 Silk Line Silk Day Cream Spf 15

Octinoxate, Octocrylene, Octisalate

NDC Product Code 53863-003

NDC CODE: 53863-003

Proprietary Name: Silk Line Silk Day Cream Spf 15 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Octinoxate, Octocrylene, Octisalate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 53863 - Exelencia Importers, Corp.

NDC 53863-003-01

Package Description: 50 mL in 1 BOX

NDC Product Information

Silk Line Silk Day Cream Spf 15 with NDC 53863-003 is a a human over the counter drug product labeled by Exelencia Importers, Corp.. The generic name of Silk Line Silk Day Cream Spf 15 is octinoxate, octocrylene, octisalate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Exelencia Importers, Corp.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Silk Line Silk Day Cream Spf 15 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OCTOCRYLENE 7 g/100mL
  • OCTISALATE 2 g/100mL
  • OCTINOXATE 7.5 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • WATER (UNII: 059QF0KO0R)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • BETA CAROTENE (UNII: 01YAE03M7J)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • IMIDUREA (UNII: M629807ATL)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CALCIUM CATION (UNII: 2M83C4R6ZB)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Exelencia Importers, Corp.
Labeler Code: 53863
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-26-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Silk Line Silk Day Cream Spf 15 Product Label Images

Silk Line Silk Day Cream Spf 15 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active Ingredient PurposeOctinoxate(Ethylhexyl methoxycinnamate) 7.5% SunscreenOctocrylene 7.0% SunscreenOctisalate (Ethylhexyl salicylate) 2.0 Sunscreen

Otc - Purpose

UsesHelps prevent sunburnHigher SPF gives more sunburn protectionIf 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

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

Indications & Usage

Stop use and ask a doctor if rash occurs

Warnings

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

DirectionsApply 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

Inactive ingredientsPurified 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

* Please review the disclaimer below.