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Silk Line Silk Day Cream SPF 15 Octinoxate, Octocrylene, Octisalate 7 g/100mL; 2 g/100mL; 7.5 g/100mL Cream, 50 mL — NDC 53863-0003-01 package photo

Silk Line Silk Day Cream SPF 15 Octinoxate, Octocrylene, Octisalate 7 g/100mL; 2 g/100mL; 7.5 g/100mL Cream, 50 mL

by Exelencia Importers, Corp. · 50 mL in 1 BOX (53863-003-01)
NDC 53863-0003-01
🏷️ FDA NDC (as labeled) 53863-003-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 53863-003-01
Product NDC 53863-003
11-digit billing NDC 53863000301
UNII 5A68WGF6WM, 4X49Y0596W, 4Y5P7MUD51
UPC 7798114893504
Application # M020
SPL Set ID b2d35086-748b-55d0-e053-2995a90a1898
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-10-26
Route TOPICAL
Dosage form CREAM
Substance OCTOCRYLENE; OCTISALATE; OCTINOXATE
Why two NDCs? The FDA registers this code as 53863-003-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 53863-0003-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerExelencia Importers, Corp.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code53863
First marketedOct 2020
Product typeHuman Otc Drug
Portfolio2 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

Silk Line Silk Day Cream SPF 15 is a topical cream marketed as an over-the-counter sunscreen under FDA's monograph rules for sunscreen products. It contains three active ingredients (octinoxate, octisalate, and octocrylene) that function as ultraviolet light absorbers, typically used to help protect skin from sun exposure. This type of product is commonly applied to exposed skin as part of daily sun protection routines.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 01YAE03M7J
    Beta carotene is a naturally occurring orange pigment found in plants. In medicines, it serves as a colorant to make tablets or capsules appear orange or yellow.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 59TL3WG5CO
    A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII NMQ347994Z
    Cyclomethicone is a silicone-based fluid that acts as a lubricant and solvent in medicines. It helps products flow smoothly, reduces friction between particles, and aids in even distribution of active ingredients.
  • UNII 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • UNII 343C7U75XW
    Dimethiconol is a silicone-based fluid that acts as an anti-foaming agent and lubricant in medications. It reduces bubble formation during manufacturing and helps the medicine flow smoothly through equipment.
  • UNII BYR0546TOW
    DMDM hydantoin is a preservative chemical used to prevent the growth of bacteria and fungi in medicines. It helps keep the product safe and stable throughout its shelf life.
  • UNII 8U5D034955
    Calcium disodium EDTA is a chemical compound that binds to metal ions. It's used in medicines as a stabilizer to prevent discoloration and maintain ingredient freshness during storage.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII M629807ATL
    Imidazolidinyl urea is a synthetic preservative that prevents microbial growth in medicines. It's used in formulations to extend shelf life and maintain product safety during storage.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • UNII 3NY3SM6B8U
    A microorganism used as a natural source of B vitamins and proteins. In medications, yeast serves as a nutrient supplement and may help with tablet binding or act as a filler to give the product proper form and stability.

26 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesInactive 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

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Silk Line Silk Day Cream SPF 15 7 g/100mL; 2 g/100mL; 7.5 g/100mLthis 53863-0003-01 Exelencia 50 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2020
On the market since
Oct 2020
📍
2026
Currently FDA-listed
6 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
53863-0003-01 You're viewing this 50 mL in 1 BOX (53863-003-01) 2020-10-26 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 53863-003-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 53863-0003-01, written without dashes as 53863000301. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 53863-0003-01, the first segment (53863) is the labeler code FDA assigned to Exelencia Importers, Corp.; the middle segment (0003) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Exelencia Importers, Corp.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Exelencia Importers, Corp. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 9 words ▾

Stop use and ask a doctor if rash occurs

⏱️ Dosage and Administration 99 words ▾

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.

⚠️ Warnings 40 words ▾

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.

🧪 Active Ingredient 15 words ▾

Active Ingredient Purpose Octinoxate(Ethylhexyl methoxycinnamate) 7.5% Sunscreen Octocrylene 7.0% Sunscreen Octisalate (Ethylhexyl salicylate)

2.0 Sunscreen

🧪 Inactive Ingredients 59 words ▾

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

🎯 Purpose 34 words ▾

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 53863-0002-01 · Exelencia 53863-0004-01 · Exelencia →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.