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Journee Firm Riche Broad Spectrum Sunscreen SPF 30 TITANIUM DIOXIDE and ZINC OXIDE 12.25 mg/mL; 10.2 mg/mL Cream — NDC 46783-0110-50 package photo

Journee Firm Riche Broad Spectrum Sunscreen SPF 30 TITANIUM DIOXIDE and ZINC OXIDE 12.25 mg/mL; 10.2 mg/mL Cream

by Merz North America, Inc. · 1 BOTTLE, PLASTIC in 1 CARTON (46783-110-50) / 50 mL in 1 BOTTLE, PLASTIC
NDC 46783-0110-50
🏷️ FDA NDC (as labeled) 46783-110-50 billing pads the product segment with a zero
This package
Contains50 mL in 1 bottle, plastic Pack sizes3 compare ↓
Also comes in: 15 mL 46783-0110-15 6 ml 46783-0110-06
OTC On market Non-controlled
🗂️ Data synced Aug 20, 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) 46783-110-50
Product NDC 46783-110
11-digit billing NDC 46783011050
UNII 15FIX9V2JP, SOI2LOH54Z
UPC 0810235030129
Application # M020
SPL Set ID d4d4bfcf-3674-4847-8ad8-1716a8e821ae
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-03-15
Route TOPICAL
Dosage form CREAM
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 46783-110-50 — 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 → 46783-0110-50. 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

LabelerMerz North America, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code46783
First marketedMar 2023
Product typeHuman Otc Drug
Portfolio5 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?

Journee Firm Riche Broad Spectrum Sunscreen SPF 30 is a topical cream containing titanium dioxide and zinc oxide as active ingredients. These mineral compounds are commonly used in sunscreens to reflect and scatter ultraviolet (UV) light away from the skin. This product is marketed as an over-the-counter (OTC) monograph drug, meaning it follows FDA's established safety and effectiveness standards for sunscreen products in this category.

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.

💊 What it looks like

Color White
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 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 4V59G5UW9X
    Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • 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 114P5I43UJ
    A hydrocarbon oil derived from petroleum, containing 13 to 15 carbon atoms per molecule. It serves as a lubricant and glidant in tablets and capsules to reduce friction during manufacturing and improve powder flow.
  • 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 Q95M2P1KJL
    A silicone-based ingredient that acts as a lubricant and glidant. It helps the tablet or capsule move smoothly through manufacturing equipment and improves powder flow during production.
  • UNII 8HO6PVN24W
    Carnosine is a naturally occurring compound made from two amino acids. In medicines, it may serve as a buffer to help maintain the product's pH stability.
  • 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 1E5KJY107T
    A liquid mixture derived from coconut oil, coconut alkanes serve as a solvent and lubricant in medicines. They help dissolve active ingredients and reduce friction during manufacturing and tablet compression.
  • UNII 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • UNII G3232Z5S2O
    A synthetic emollient and emulsifier derived from plant oils and glycerin. It helps blend oil and water components together and gives the product a smooth texture in topical formulations.
  • 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 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • UNII ZH1WJO5481
    A silicone-based compound that acts as a lubricant and anti-foaming agent in medicines. It helps prevent clumping, reduces bubbles during manufacturing, and improves how the medicine flows and spreads.
  • 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 EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII 4P26HG1S5W
    A plant extract from sunflower sprouts used in formulations as an antioxidant and preservative to help maintain product stability and prevent degradation of active ingredients.
  • UNII G9813R29TW
    A protein derived from human skin that has been partially broken down into smaller pieces. It acts as a binder and thickener in formulations, helping hold ingredients together and adjust texture.
  • 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 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 918X1OUF1E
    Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
  • 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 O0CV1RMR44
    A dark pigment made synthetically from tyrosine and peroxide. It's used as a colorant in tablets and capsules to give medicines their color and help distinguish different dosages visually.
  • UNII 99B84UAK70
    A synthetic peptide derived from amino acids, used as a skin-conditioning agent and emollient in topical formulations to help soften and moisturize the skin surface.
  • UNII F3VOA31UHQ
    A natural oil extracted from passion fruit seeds. It serves as an emollient and skin-conditioning agent in topical products, helping to soften and moisturize the formulation while improving texture and spreadability.
  • UNII 8PR7V1SVM0
    A silicone-based lubricant combined with polyethylene glycol. It reduces friction and helps the medicine flow smoothly during manufacturing and improves how the product feels when applied or swallowed.
  • UNII TYP81E471F
    A silicone-based lubricant and anti-foaming agent derived from dimethicone, a synthetic polymer. It helps reduce friction during tablet or capsule manufacturing and prevents excessive foam in liquid formulations.
  • UNII 9H0AO7T794
    A silicone-based lubricant mixed with polyethylene glycol and polypropylene glycol polymers. It reduces friction between pill surfaces and equipment during manufacturing, and helps the finished product slide smoothly when swallowed.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • 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 XRQ165498B
    A plant-derived emulsifier made from glycerin and oleic acid. It helps mix oil and water-based ingredients together in the formulation and improves product texture and stability.
  • UNII 687U3PEB2Y
    A complex emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients together and improves the texture and stability of creams, lotions, and other formulated products.
  • UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • 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 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 836SJG51DR
    Sodium ascorbyl phosphate is a derivative of vitamin C that acts as an antioxidant and preservative in medications. It helps protect the drug's active ingredients from degradation caused by air and light exposure.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII OLX698AH5P
    A clay mineral processed with a quaternary ammonium compound. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
  • 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 EXY4496LWD
    A plant-derived ingredient from the pods of the Caesalpinia spinosa tree, native to South America. It's used as a natural thickener, binder, and source of fiber in formulations.
  • UNII 179JUC43HU
    A synthetic peptide (short chain of amino acids) used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product's texture on skin.
  • 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 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 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 89DS0H96TB
    Zinc sulfate is a mineral salt used in medications as a source of zinc. It functions as an active nutritional ingredient in some formulations and may also serve as a buffer or pH stabilizer in tablets and liquids.

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

The official label also statesWater, Dimethicone, Coconut Alkanes, C12-15 Alkyl Benzoate, Isohexadecane, Ethyl Trisiloxane, Polyhydroxystearic Acid, PEG-10 Dimethicone, Isododecane, Glycerin, Butyloctyl Salicylate, Propanediol, Squalane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Zinc Sulfate, Caprylic/Capric Triglyceride, Cutaneous Lysate, Tetrapeptide-21, Capryloyl Carnosine, Caesalpinia Spinosa Fruit Pod Extract, Palmitoyl Tripeptide-1 Acetate, Sodium Hyaluronate, Argania Spinosa Kernel Oil, Passiflora Edulis Seed Oil, Butyrospermum ParkII (Shea) Butter, Camellia Sinensis Leaf Extract, Helianthus Annuus (Sunflower) Sprout Extract, Alumina, Caprylyl Methicone, Coco-Caprylate/Caprate, Stearic Acid, Polyglyceryl-3 Oleate, Stearalkonium Hectorite, C13-15 Alkane, Caprylyl Glycol, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Polysilicone-11, Propylene Carbonate, Xanthan Gum, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Maltodextrin, Ethylhexylglycerin, Triethoxycaprylylsilane, PEG/PPG-18/18 Dimethicone, Melanin, Pentylene Glycol, Tocopherol, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499), Phenoxyethanol, Citric Acid

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: 15 mL 6 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
Journee Firm Riche Broad Spectrum Sunscreen SPF 30 12.25 mg/mL; 10.2 mg/mLthis 46783-0110-50 Merz 1 bottle — — 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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Journee Firm Riche Broad Spectrum Sunscreen SPF 30 (this brand).

Top reported reactions

Acute Myeloid Leukaemia1
Exposure To Toxic Agent1
Product Contamination Chemical1

Reporter sex

1 reports
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 1 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
46783-0110-06 6 mL in 1 TUBE (46783-110-06) 2023-03-15 Active
46783-0110-15 1 BOTTLE, PLASTIC in 1 CARTON (46783-110-15) / 15 mL in 1 BOTTLE, PLASTIC 2023-03-15 Active
46783-0110-50 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (46783-110-50) / 50 mL in 1 BOTTLE, PLASTIC 2023-03-15 Active

Pack size FAQ

What quantity is in NDC 46783-0110-50?
NDC 46783-0110-50 is listed by the FDA — 1 bottle, plastic in 1 carton / 50 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of Journee Firm Riche Broad Spectrum Sunscreen SPF 30 TITANIUM DIOXIDE and ZINC OXIDE 12.25 mg/mL; 10.2 mg/mL Cream?
Bill NDC 46783-0110-50 — the 11-digit billing format is 46783011050. 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 46783-110-50, 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: 46783-0110-50, written without dashes as 46783011050. 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 46783-0110-50, the first segment (46783) is the labeler code FDA assigned to Merz North America, Inc.; the middle segment (0110) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 Merz North America, Inc.. 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 2 other package presentations of this same product, including 1 bottle (46783-0110-15), 6 ml (46783-0110-06). 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?
Merz North America, Inc. 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 40 words ▾

Uses Helps prevent sunburn and premature skin aging. 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. Higher SPF gives more sunburn protection.

⏱️ Dosage and Administration 86 words ▾

Directions Apply generously 15 minutes before sun exposure. For children under 6 months of age, ask a doctor. Sun-Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging.

To decrease the 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 10am-2pm. Wear long-sleeved shirts, pants, hats, and sunglasses. Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

⚠️ 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.

📦 Storage and Handling 11 words ▾

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

🧪 Active Ingredient 8 words ▾

Active Ingredients Titanium Dioxide 12.25% Zinc Oxide 10.2%

🧪 Inactive Ingredients 120 words ▾

Inactive Ingredients Water, Dimethicone, Coconut Alkanes, C12-15 Alkyl Benzoate, Isohexadecane, Ethyl Trisiloxane, Polyhydroxystearic Acid, PEG-10 Dimethicone, Isododecane, Glycerin, Butyloctyl Salicylate, Propanediol, Squalane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Zinc Sulfate, Caprylic/Capric Triglyceride, Cutaneous Lysate, Tetrapeptide-21, Capryloyl Carnosine, Caesalpinia Spinosa Fruit Pod Extract, Palmitoyl Tripeptide-1 Acetate, Sodium Hyaluronate, Argania Spinosa Kernel Oil, Passiflora Edulis Seed Oil, Butyrospermum ParkII (Shea) Butter , Camellia Sinensis Leaf Extract, Helianthus Annuus (Sunflower) Sprout Extract, Alumina, Caprylyl Methicone, Coco-Caprylate/Caprate, Stearic Acid, Polyglyceryl-3 Oleate, Stearalkonium Hectorite, C13-15 Alkane, Caprylyl Glycol, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Polysilicone-11, Propylene Carbonate, Xanthan Gum, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Maltodextrin, Ethylhexylglycerin, Triethoxycaprylylsilane, PEG/PPG-18/18 Dimethicone, Melanin, Pentylene Glycol, Tocopherol, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499), Phenoxyethanol, Citric Acid

🎯 Purpose 2 words ▾

Purpose Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 46783-0004-04 · Merz 46783-0160-01 · Merz →
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.