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Almay Healthy Biome Makeup Homosalate, Octisalate, Octocrylene, Titanium Dioxide, Zinc Oxide 5 mg/mL; 5 mg/mL; 3.94 mg/mL; 5 mg/mL; 5.8 mg/mL Emulsion, 1 mL — NDC 0311-0723-01 (Billing 00311-0723-01)

by Almay · 1 mL in 1 TUBE

This is a package of 1 mL of Almay Healthy Biome Makeup Homosalate, Octisalate, Octocrylene, Titanium Dioxide, Zinc Oxide 5 mg/mL; 5 mg/mL; 3.94 mg/mL; 5 mg/mL; 5.8 mg/mL Emulsion from Almay, marketed since Jul 2020 and currently FDA-listed. It is this product's only package size.

NDC 00311-0723-01
🏷️ FDA NDC (as labeled) 0311-0723-01 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 0311-0723-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0311 labeler · 0723 product · 01 package
Package marketed since
Aug 1, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0311072301 3
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0311-0723-01
Product NDC 0311-0723
11-digit billing NDC 00311072301
UNII V06SV4M95S, 4X49Y0596W, SOI2LOH54Z, 5A68WGF6WM, 15FIX9V2JP
Application # M020
SPL Set ID ab20969a-8640-307d-e053-2a95a90a004d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-07-01
Route TOPICAL
Dosage form EMULSION
Substance HOMOSALATE; OCTISALATE; ZINC OXIDE; OCTOCRYLENE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 0311-0723-01 — a 4-4-2 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 labeler segment → 00311-0723-01. 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.

Clinical

🧪 What is this product?

Almay Healthy Biome Makeup is a topical emulsion (liquid makeup) that contains five active ingredients commonly used as ultraviolet (UV) filters in sunscreen products. Homosalate, octisalate, octocrylene, titanium dioxide, and zinc oxide are typically included in cosmetics and personal care products to help protect skin from sun exposure. This is an over-the-counter monograph product, meaning it is manufactured under FDA's established rules for sunscreen and cosmetic combinations rather than as an individually approved application.

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.

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 mLPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00311-0723-01 You're viewing this Main listing 1 mL in 1 TUBE 2020-08-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Almay Healthy Biome Makeup Tan 5 mg/mL; 5 mg/mL; 3.94 mg/mL; 5 mg/mL; 5.8 mg/mL 00311-0741-01 Almay 1 ml — — FDA listed —
Almay Healthy Biome Makeup 5 mg/mL; 5 mg/mL; 3.94 mg/mL; 5 mg/mL; 5.8 mg/mLthis 00311-0723-01 Almay 1 ml — — FDA listed —
Almay Healthy Biome Makeup Golden 5 mg/mL; 5 mg/mL; 3.94 mg/mL; 5 mg/mL; 5.8 mg/mL 00311-0740-01 Almay 1 ml — — FDA listed —
Almay Healthy Biome Makeup Light 5 mg/mL; 5 mg/mL; 3.94 mg/mL; 5 mg/mL; 5.8 mg/mL 00311-0738-01 Almay 1 ml — — FDA listed —
Almay Healthy Biome Makeup Fair 5 mg/mL; 5 mg/mL; 3.94 mg/mL; 5 mg/mL; 5.8 mg/mL 00311-0737-01 Almay 1 ml — — FDA listed —
Almay Healthy Biome Makeup Medium 5 mg/mL; 5 mg/mL; 3.94 mg/mL; 5 mg/mL; 5.8 mg/mL 00311-0739-01 Almay 1 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
Jul 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.

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 S95658MI3W
    A carbohydrate derived from starch that acts as a binder and filler in tablets and capsules. It helps hold ingredients together and adds bulk to the medicine so it's easier to manufacture and handle.
  • UNII A7E6112E4N
    A form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down, helping maintain stability and shelf life.
  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII 2EH13UN8D3
    A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII 5ZA2S6B08X
    Cetyl palmitate is a waxy substance made from natural fats. It works as a binder and thickener to help hold the medicine together and control how it dissolves in your body.
  • UNII V2W71V8T0X
    A silicone-based compound that mixes oil and water together. Used in formulations as an emulsifier to help blend ingredients and improve texture and stability of creams, lotions, and other topical products.
  • 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 UF7620L1W6
    A synthetic silicone polymer that acts as a thickener and absorbent in medicines. It helps create the right texture, improves how the product feels on skin or in the mouth, and can absorb excess moisture or oil in formulations.
  • UNII X687XDK09L
    A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • 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 4QGR4P2YOI
    A silicone-based lubricant that reduces friction between tablet particles and manufacturing equipment. It helps tablets flow smoothly during production and prevents them from sticking together or to machinery.
  • UNII H1109Z9J4N
    A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
  • UNII A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • UNII ML30MJ2U7I
    A mineral salt form of magnesium and sulfate. It serves as a filler to add bulk to the tablet or capsule and may help the medicine dissolve or disintegrate properly in the body.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • 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 90PS6JV9GZ
    A plant-derived ingredient from the Ophiopogon japonicus root, used in traditional medicine formulations. It may serve as a natural filler or consistency agent in herbal preparations.
  • UNII 6Q6H1PKC05
    A synthetic peptide derived from palmitic acid and amino acids. It functions as a skin-conditioning agent and emollient in topical formulations, helping to soften and smooth the product texture while supporting ingredient stability.
  • UNII HD40WR33LC
    A synthetic liquid compound made from polyethylene glycol and sorbitan stearate. It acts as an emulsifier to blend oil and water-based ingredients together, and also helps the medicine dissolve or disperse properly.
  • 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 46P231IQV8
    A synthetic emulsifier derived from glycerin and fatty acids. It helps blend oil and water-based ingredients together in cosmetic and pharmaceutical formulations to create stable, uniform products.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 8D08K3S51E
    Propylene carbonate is a clear liquid solvent derived from propylene. It helps dissolve or suspend active ingredients in liquid medicines and can improve how well the product flows and mixes.
  • 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 4P5T8DTR73
    A plant extract from yacon, a root vegetable native to South America. It's used as a natural sweetener, flavor enhancer, and prebiotic ingredient in medicines and supplements.
  • UNII LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • UNII 5041RX63GN
    A synthetic silicon-based polymer used as a glidant and anti-caking agent. It helps powder particles flow smoothly and prevents clumping during manufacturing and storage.
  • 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.

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

The official label also statesOther Ingredients: Aqua/Water/Eau, Cyclopentasiloxane, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Glycerin, Isododecane, Alumina, Magnesium Sulfate, Silica, Alpha-Glucan Oligosaccharide, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Palmitate, Disteardimonium Hectorite, Hydrogen Dimethicone, Hydrogenated Lecithin, Lactobacillus, Maltodextrin, Ophiopogon Japonicus Root Extract, Palmitoyl Tetrapeptide-10, Polyglyceryl-3 Diisostearate, Polymnia Sonchifolia Root Juice, Polysorbate 80, Propylene Carbonate, Simethicone, Sorbitan Stearate, Tetrasodium EDTA, Tocopheryl Acetate, Triethoxycaprylylsilane, Phenoxyethanol. MAY CONTAIN/PEUT CONTENIR/PUEDE CONTENER (+/-): [Iron Oxides (CI 77491),Iron Oxides (CI 77492),Iron Oxides (CI 77499),Titanium Dioxide (CI 77891).]

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.

Manufacturer & labeler

LabelerAlmay
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code00311
First marketedJul 2020
Product typeHuman Otc Drug
Portfolio34 products on file

More NDCs from Almay labeler code 00311

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.

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 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

Helps prevent sunbunrs. If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

⏱️ Dosage and Administration 29 words ▾

Directions Apply liberally 15 minutes before sun exposure. Use water resistant sunscreen is swimming or sweating. Repply at least ever 2 hours. Children under 6 months; Ask a doctor.

⚠️ Warnings 72 words ▾

Warnings For external use only Do not use on danaged skin or broken skin 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 a Broad spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am- 2pm. Wear long-sleeved shrirts, pants, hats and sunglasses.

🧪 Active Ingredient 15 words ▾

Active Ingredient Section Homosalate 5.0% Octisalate 5.0% Octocrylene 5.0% Titanium Dioxide 5.8% Zinc Oxide 3.94%

🧪 Inactive Ingredients 75 words ▾

Other Ingredients: Aqua/Water/Eau, Cyclopentasiloxane, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Glycerin, Isododecane, Alumina, Magnesium Sulfate, Silica, Alpha-Glucan Oligosaccharide, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Palmitate, Disteardimonium Hectorite, Hydrogen Dimethicone, Hydrogenated Lecithin, Lactobacillus, Maltodextrin, Ophiopogon Japonicus Root Extract, Palmitoyl Tetrapeptide-10, Polyglyceryl-3 Diisostearate, Polymnia Sonchifolia Root Juice, Polysorbate 80, Propylene Carbonate, Simethicone, Sorbitan Stearate, Tetrasodium EDTA, Tocopheryl Acetate, Triethoxycaprylylsilane, Phenoxyethanol.

MAY CONTAIN/PEUT CONTENIR/PUEDE CONTENER (+/-): [Iron Oxides (CI 77491),Iron Oxides (CI 77492),Iron Oxides (CI 77499),Titanium Dioxide (CI 77891).]

🎯 Purpose 27 words ▾

Uses Helps prevent sunburn. if used as directed with other sun protection measures descreases the risk of skin cancer and early skin aging caused by the sun.

📄 When Using This Product 23 words ▾

When using this product Keep out of the eyes, Rinse with water to remove. Stop use and ask a doctor if rash occurs.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children If product is swalled get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 4 words ▾

back label front label

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

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 — Not published for this NDC No photo available yet for this listing.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Almay. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Almay 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.
← 00311-0714-17 · Almay, 00311-0725-30 · ALMAY →
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.