Ultra Replenishing Sunscreen SPF 40 Homosalate, Octisalate, Octocrylene, Zinc Oxyide cream 80 mg/mL; 50 mg/mL; 80 mg/mL; 50 mg/mL Cream, 50 mL — NDC 70060-1901-01 package photo

Ultra Replenishing Sunscreen SPF 40 Homosalate, Octisalate, Octocrylene, Zinc Oxyide cream 80 mg/mL; 50 mg/mL; 80 mg/mL; 50 mg/mL Cream, 50 mL

by CosMedical Technologies, LLC · 50 mL in 1 BOTTLE, PLASTIC (70060-1901-1)
NDC 70060-1901-01
🏷️ FDA NDC (as labeled) 70060-1901-1 billing pads the package segment with a zero
This package
Contains50 mL Pack sizes2 compare ↓
Also comes in: 1.5 ml 70060-1901-02
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 →

🆔 Identity & classification

FDA NDC (as labeled) 70060-1901-1
Product NDC 70060-1901
11-digit billing NDC 70060190101
UNII V06SV4M95S, 5A68WGF6WM, SOI2LOH54Z, 4X49Y0596W
Application # M020
SPL Set ID 92ad5d7a-9adb-7d55-e053-2995a90a80e7
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-09-16
Route TOPICAL
Dosage form CREAM
Substance HOMOSALATE; OCTOCRYLENE; ZINC OXIDE; OCTISALATE
Why two NDCs? The FDA registers this code as 70060-1901-1 — a 5-4-1 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 package segment → 70060-1901-01. 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

LabelerCosMedical Technologies, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code70060
First marketedSep 2019
Product typeHuman Otc Drug
Portfolio3 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?

Ultra Replenishing Sunscreen SPF 40 is a topical cream containing four active ingredients that function as UV filters. Homosalate, octisalate, and octocrylene are organic sunscreen agents that absorb ultraviolet light, while zinc oxide is a mineral UV filter that reflects and scatters light. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for sunscreen formulations rather than undergoing individual review.

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 A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • 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 I670DAL4SZ
    A preservative that fights bacteria and fungi. It keeps medicines and topical products stable and safe from microbial contamination during storage and use.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII XBH432G01F
    A synthetic antioxidant compound used to prevent oxidation and degradation of the active ingredients and other components in the medicine, helping maintain its stability and shelf life.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII 6YSS42VSEV
    Fructose is a natural sugar derived from fruits and plants. It's used in medicines as a sweetener and filler to improve taste and add bulk to tablets or syrups.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII 7B7U9D12AI
    A plant root extract used as a flavoring and fragrance ingredient. It adds taste and aroma to the medicine and may help mask unpleasant flavors in the formulation.
  • UNII V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • UNII AKN3KSD11B
    Orange oil obtained by cold pressing orange peel. It serves as a flavoring agent and fragrance in medicines to improve taste and aroma.
  • 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 88496G1ERL
    Sodium phytate is a plant-derived salt used in medications as a chelating agent and preservative. It helps stabilize formulations and may improve how the body absorbs certain minerals in the medicine.
  • UNII 253MC0P0YV
    A waxy compound made from glycerin and stearic acid, used as an emulsifier to help mix oil and water-based ingredients together in the formulation.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII V56DFE46J5
    Steareth-2 is a synthetic emulsifier made from stearic acid and ethylene oxide. It helps mix oil and water-based ingredients together in the formulation and may improve how the medicine spreads or dissolves.
  • UNII 53J3F32P58
    A synthetic detergent derived from stearic acid, a fatty substance. It helps dissolve or distribute oil-based ingredients evenly throughout the medicine, acting as an emulsifier and solubilizer in tablets and capsules.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII Q74T35078H
    Vanilla is a flavoring ingredient extracted from vanilla orchid beans. It's added to medicines to improve taste and make them more pleasant to take, especially for children or patients who need liquid formulations.
  • 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 2HZ95R7082
    Withania somnifera flower is a plant extract used as a natural ingredient. It may serve as a flavoring agent, color component, or botanical additive in the formulation.

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

The official label also statesWater C12-15 Alkyl Benzoate Glycerin Mica Polyglyceryl-2 Stearate Glyceryl Stearate Steareth-21 Stearyl Alcohol Dimethicone Phenoxyethanol Simmondsia Chinensis (Jojoba) Seed Oil Steareth-2 Fructose Cocos Nucifera (Coconut) Oil Citric Acid Ethylhexylglycerin Hydroxyethylcellulose Chlorphenesin Hydrolyzed Rice Protein Titanium Dioxide (CI 77891) Tocopheryl Acetate Kaempferia Galanga Root Extract Aloe Barbadensis Leaf Juice Sodium Phytate Lavandula Angustifolia (Lavender) Oil Withania Somnifera Flower Extract Iron Oxide (CI 77492) Iron Oxide (CI 77491) Citrus Aurantium Dulcis (Orange) Peel Oil Silica Dimethylmethoxy Chromanol Vanilla Planifolia Fruit Extract Iron Oxide (CI 77499)

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.
Try another pack size: 1.5 ml
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
Ultra Replenishing Sunscreen SPF 40 80 mg/mL; 50 mg/mL; 80 mg/mL; 50 mg/mLthis 70060-1901-01 CosMedical 50 ml — — FDA listed —
Urban Antioxidant Sunscreen SPF 40 80 mg/mL; 50 mg/mL; 80 mg/mL; 50 mg/mL 71501-1902-01 Dr. 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

🏛️
2019
On the market since
Sep 2019
📍
2026
Currently FDA-listed
7 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
70060-1901-01 You're viewing this 50 mL in 1 BOTTLE, PLASTIC (70060-1901-1) 2019-09-16 Active
70060-1901-02 1.5 mL in 1 PACKET (70060-1901-2) 2019-09-16 Active

Pack size FAQ

What quantity is in NDC 70060-1901-01?
NDC 70060-1901-01 contains 50 mL — 50 ml in 1 bottle, plastic.
What is the difference between NDC 70060-1901-01 and NDC 70060-1901-02?
Both are Ultra Replenishing Sunscreen SPF 40 Homosalate, Octisalate, Octocrylene, Zinc Oxyide cream 80 mg/mL; 50 mg/mL; 80 mg/mL; 50 mg/mL Cream — the drug itself is identical. NDC 70060-1901-01 is the 50 mL package, while NDC 70060-1901-02 is the 1.5 ml package.
What NDC number is used to bill for this package of Ultra Replenishing Sunscreen SPF 40 Homosalate, Octisalate, Octocrylene, Zinc Oxyide cream 80 mg/mL; 50 mg/mL; 80 mg/mL; 50 mg/mL Cream?
Bill NDC 70060-1901-01 — the 11-digit billing format is 70060190101. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 70060-1901-1, 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: 70060-1901-01, written without dashes as 70060190101. 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 70060-1901-01, the first segment (70060) is the labeler code FDA assigned to CosMedical Technologies, LLC; the middle segment (1901) 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 CosMedical Technologies, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1.5 ml (70060-1901-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
CosMedical Technologies, LLC 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 4 words ▾

Uses Helps prevent sunburn

⏱️ Dosage and Administration 98 words ▾

Directions • Apply liberally and evenly 15 minutes before sun exposure. • Reapply: at least every 2 hours • Use a water-resistant sunscreen if swimming or sweating. • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.–2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses • Children under 6 months of age: Ask a doctor.

⚠️ Warnings 54 words ▾

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. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 9 words ▾

Homosalate 8% Octisalate 5% Octocrylene 5% Zinc Oxide 8%

🧪 Inactive Ingredients 83 words ▾

Water C12-15 Alkyl Benzoate Glycerin Mica Polyglyceryl-2 Stearate Glyceryl Stearate Steareth-21 Stearyl Alcohol Dimethicone Phenoxyethanol Simmondsia Chinensis (Jojoba) Seed Oil Steareth-2 Fructose Cocos Nucifera (Coconut) Oil Citric Acid Ethylhexylglycerin Hydroxyethylcellulose Chlorphenesin Hydrolyzed Rice Protein Titanium Dioxide (CI 77891) Tocopheryl Acetate Kaempferia Galanga Root Extract Aloe Barbadensis Leaf Juice Sodium Phytate Lavandula Angustifolia (Lavender) Oil Withania Somnifera Flower Extract Iron Oxide (CI 77492) Iron Oxide (CI 77491) Citrus Aurantium Dulcis (Orange) Peel Oil Silica Dimethylmethoxy Chromanol Vanilla Planifolia Fruit Extract Iron Oxide (CI 77499)

🎯 Purpose 1 words ▾

Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.