ULTRA SHEER DAILY DEFENSE FACIAL SPF 18 Homosalate, Octisalate, and Avobenzone 120 mg/mL; 40 mg/mL; 30 mg/mL Lotion — NDC 55560-3331-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ULTRA SHEER DAILY DEFENSE FACIAL SPF 18 Homosalate, Octisalate, and Avobenzone 120 mg/mL; 40 mg/mL; 30 mg/mL Lotion — NDC 55560-3331-1 (Billing 55560-3331-01)

by Andalou naturals · 1 TUBE in 1 BOX / 80 mL in 1 TUBE

This is a package of ULTRA SHEER DAILY DEFENSE FACIAL SPF 18 Homosalate, Octisalate, and Avobenzone 120 mg/mL; 40 mg/mL; 30 mg/mL Lotion from Andalou naturals, marketed since Jan 2021 and currently FDA-listed. It is this product's only package size.

NDC 55560-3331-01
🏷️ FDA NDC (as labeled) 55560-3331-1 billing pads the package 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 →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55560-3331-1
Product NDC 55560-3331
11-digit billing NDC 55560333101
UNII V06SV4M95S, 4X49Y0596W, G63QQF2NOX
Application # M020
SPL Set ID 0f7c6d3a-73ea-44d8-a8b9-6a6f1bb02c6f
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-01-01
Route TOPICAL
Dosage form LOTION
Substance HOMOSALATE; OCTISALATE; AVOBENZONE
Why two NDCs? The FDA registers this code as 55560-3331-1 — 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 → 55560-3331-01. 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?

This is a topical lotion sunscreen marketed as an over-the-counter monograph product. It contains three active ingredients, homosalate, octisalate, and avobenzone, which are ultraviolet light filters commonly used together in sunscreen formulations to help absorb and scatter UVA and UVB radiation from the sun. The product is typically applied to the face and exposed skin as part of a daily skincare routine. SPF 18 indicates the level of protection this formulation is intended to provide against ultraviolet B rays.

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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
55560-3331-01 You're viewing this Main listing 1 TUBE in 1 BOX / 80 mL in 1 TUBE 2021-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ultra Sheer Daily Defense Facial Spf 18 120 mg/mL; 40 mg/mL; 30 mg/mLthis 55560-3331-01 Andalou 1 tube — — 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

🏛️
2021
On the market since
Jan 2021
📍
2026
Currently FDA-listed
5 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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 46AM2VJ0AW
    A dried fruit powder from the acai berry, used as a natural colorant and flavor ingredient to add purple-red color and fruity taste to medicines and supplements.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • 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 B423VGH5S9
    A natural fruit ingredient derived from apples, used as a flavoring agent and sweetener to improve taste and palatability of the medicine.
  • UNII D2EVP827PJ
    A juice extract from aronia berries, a dark purple fruit. It's used as a natural colorant and flavoring agent to add color and taste to the medication.
  • UNII H7UGK1GJCU
    Aspalathus linearis leaf is a plant extract from rooibos tea. It's used in medicines as a natural flavor and color agent, and may help preserve the product's stability.
  • UNII P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • 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 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 WH8T92A065
    A fatty acid derivative made by combining stearic acid with glycerin and citric acid. It acts as an emulsifier to help mix oil and water-based ingredients, and also serves as a thickener in the medicine formulation.
  • UNII 45TGG6IU6M
    A natural plant extract from hibiscus flowers used as a colorant and flavoring agent in medicines. It adds red or purple color and a tart taste to tablets, capsules, and liquid formulations.
  • 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 S870P55O2W
    Isomalt is a sugar alcohol made from sugar that's used as a sweetener and bulking agent in medicines. It helps give tablets and powders the right texture and sweetness while having minimal calories.
  • UNII 930626MWDL
    A plant extract from goji berries used as a natural coloring agent and flavor enhancer in medicines. It may add color and taste while serving as a source of beneficial plant compounds in the formulation.
  • UNII 0R822556M5
    A stabilized form of vitamin C derived from ascorbic acid and magnesium. It's used as an antioxidant and preservative to prevent ingredient degradation and extend shelf life in medications and supplements.
  • 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 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII Q369O8926L
    Resveratrol is a plant-derived compound sometimes added to supplements and fortified products. It may serve as an active nutritional ingredient rather than a traditional inactive filler, though its exact formulation role varies by product.
  • UNII 0W8RRI5W5A
    A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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 GH42T47V24
    A plant extract from tea leaves that acts as an antioxidant and flavor ingredient. It helps preserve the medicine and improve its taste.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII EJ27X76M46
    Ubidecarenone is a naturally occurring compound found in cells that helps produce energy. In medicines, it acts as an antioxidant and may help stabilize the product while supporting cellular function in the body.
  • UNII ZLW3M94UYA
    A natural extract from grape fruit cells, rich in tannins and polyphenols. Used in formulations as an antioxidant and preservative to help protect the product from degradation during 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.
  • 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.

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

The official label also statesAqua/Water/Eau, Glycerin, Aloe Barbadendis (Aloe Vera) Leaf Juice Certified Organic Ingredient, Sorbitan Sesquioleate, Glyceryl Stearate, Natural Fragrance, Stearyl Alcohol, Phenoxyethanol, Cetyl Alcohol, Stearic Acid, C12-15 Alkyl Benzoate, Glyceryl Stearate Citrate, Malus Domestica (Apple) Fruit Cell Culture, Lecithin, Xanthan Gum, Carbomer, Panthenol (Pro-Vitamin B5), Malus Domestica (Apple) Fruit Cell Culture Extract, Tocopherol (Vitamin E), Ethylhexylglycerin, Allantoin, Vitis Vinifera (Grape) Callus Culture Extract, 1,2-Hexanediol, Sodium Hyaluronate, Euterpe Oleracea (Açai) Fruit Extract, Aronia Melanocarpa (Black Chokeberry) Fruit Extract, Lycium Barbarum (Goji) Fruit Extract, Camellia Sinensis (White Tea) Leaf Extract, Pichia/Resveratrol Ferment Extract, Potassium Sorbate, Magnesium Ascorbyl Phosphate (Vitamin C), Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Alcohol, Aspalathus Linearis (Rooibos) Leaf Extract, Hibiscus Sabdariffa (Roselle) Flower Extract, Calendula Officinalis Flower Extract, Ubiquinone (Co-Enzyme Q10).

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

LabelerAndalou naturals
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code55560
First marketedJan 2021
Product typeHuman Otc Drug
Portfolio8 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.

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 30 words ▾

Uses Helps prevent sunburn. 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 114 words ▾

Directions Daily, alone or under make-up. Apply liberally 15 minutes before sun exposure and as needed. Reapply every 2 hours or after swimming, towel drying, perspiring heavily, washing, or in the case of products applied to the lips, after eating or drinking.

Use water resistant sunscreen if swimming or sweating. Children under 6 months: ask a doctor. 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 of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am-2pm Wear long sleeve shirts, pants and sunglasses.

⚠️ Warnings 59 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 or irritation develops and lasts. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 14 words ▾

Other Information Protect the product in this container from excessive heat and direct sun.

🧪 Active Ingredient 13 words ▾

Active Ingredients Purpose Homosalate 12.0% Sunscreen Octyl Salicylate 4.0% Sunscreen Avobenzone 3.0% Sunscreen

🧪 Inactive Ingredients 132 words ▾

Inactive Ingredients Aqua/Water/Eau, Glycerin, Aloe Barbadendis (Aloe Vera) Leaf Juice Certified Organic Ingredient , Sorbitan Sesquioleate, Glyceryl Stearate, Natural Fragrance, Stearyl Alcohol, Phenoxyethanol, Cetyl Alcohol, Stearic Acid, C12-15 Alkyl Benzoate, Glyceryl Stearate Citrate, Malus Domestica (Apple) Fruit Cell Culture, Lecithin, Xanthan Gum, Carbomer, Panthenol (Pro-Vitamin B5), Malus Domestica (Apple) Fruit Cell Culture Extract, Tocopherol (Vitamin E), Ethylhexylglycerin, Allantoin, Vitis Vinifera (Grape) Callus Culture Extract, 1,2-Hexanediol, Sodium Hyaluronate, Euterpe Oleracea (Açai) Fruit Extract , Aronia Melanocarpa (Black Chokeberry) Fruit Extract , Lycium Barbarum (Goji) Fruit Extract , Camellia Sinensis (White Tea) Leaf Extract , Pichia/Resveratrol Ferment Extract, Potassium Sorbate, Magnesium Ascorbyl Phosphate (Vitamin C), Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Alcohol , Aspalathus Linearis (Rooibos) Leaf Extract , Hibiscus Sabdariffa (Roselle) Flower Extract , Calendula Officinalis Flower Extract , Ubiquinone (Co-Enzyme Q10).

🎯 Purpose 13 words ▾

Active Ingredients Purpose Homosalate 12.0% Sunscreen Octyl Salicylate 4.0% Sunscreen Avobenzone 3.0% Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin.

📄 When Using This Product 13 words ▾

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

📄 Stop Use and Ask a Doctor If 13 words ▾

Stop use and ask a doctor if rash or irritation develops and lasts.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 7 words ▾

Questions Call (888) 898-6955 or visit www.Andalou.com

📄 Package Label / Principal Display Panel 51 words ▾

PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton SUNSCREEN ANDALOU NATURALS Ultra Sheer DAILY DEFENSE Facial Lotion SPF 18 with Resveratrol + CoQ10 + Hyaluronic Acid Broad Spectrum SPF 18 FRUIT STEM CELL SCIENCE ® AGE DEFYING 2.7 fl oz / 80 mL PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton

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 ✓ 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 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 Andalou naturals. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Andalou naturals 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.
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.