toty Solaria Mineral Titanium Dioxide, Zinc Oxide 7 g/100g; 6 g/100g Cream
by Chipican LLC · 1 BOTTLE in 1 CARTON (82141-3161-3) / 30 g in 1 BOTTLE
NDC 82141-3161-03
🏷️ FDA NDC (as labeled)
82141-3161-3
billing pads the package segment with a zero
This package
Contains30 g in 1 bottle
Pack sizes4 compare ↓
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Titanium Dioxide, Zinc Oxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 3, 2024 — Microbial Contamination of Non-Sterile Product (Vivier Pharma, Inc.) · FDA recall D-0662-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
82141-3161-3
Product NDC
82141-3161
11-digit billing NDC
82141316103
UNII
15FIX9V2JP, SOI2LOH54Z
UPC
0382141000119
Application #
M020
SPL Set ID
e9d590d8-e71a-0715-e053-2a95a90a5acf
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2023-06-01
Route
TOPICAL
Dosage form
CREAM
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs?
The FDA registers this code as 82141-3161-3 — 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 → 82141-3161-03. 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
LabelerChipican LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code82141
First marketedJun 2023
Product typeHuman Otc Drug
Portfolio32 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?
Toty Solaria Mineral is a topical cream containing titanium dioxide and zinc oxide. Both minerals function as physical sunscreen agents that work by reflecting and scattering ultraviolet rays away from the skin. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for sunscreen products rather than being individually approved. It is commonly applied to exposed skin to help protect against sun exposure.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Titanium Dioxide, Zinc Oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 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 6MW60CB71P
A stabilized form of vitamin C used as an antioxidant in medicines. It prevents other ingredients from breaking down or discoloring during storage.
-
UNII U04IC2765C
A clear liquid alcohol derived from phenyl compounds, used as a solvent and preservative in liquid medicines to help dissolve active ingredients and prevent microbial growth.
-
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 5QB0T2IUN0
Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
-
UNII RS7A450LGA
A sodium salt derived from citric acid that helps regulate acidity and maintain pH balance in the medicine. It also works as a binding agent to hold tablet ingredients together.
-
UNII 94ZLA3W45F
Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
-
UNII V5RS026Q0H
A synthetic polymer made by combining several plastic-like compounds. It forms a protective coating on tablets or capsules to control where and when the medicine dissolves in the digestive system.
-
UNII 3XUS85K0RA
Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
-
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 QS58JP94CS
A single-celled green alga used as a natural colorant and nutritional ingredient. It provides green pigmentation and may serve as a filler or nutritional additive in supplements and fortified foods.
-
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 21AS8B1BSS
A silicone-based ingredient that combines dimethicone (silicone oil) with polyethylene glycol. It works as a skin-conditioning agent and texture enhancer, helping smooth the product's feel and improve how it spreads on skin.
-
UNII E107L85C40
Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
-
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 MJ2YTT4J8M
Ethyl linoleate is a fatty acid ester derived from linoleic acid. It acts as an emollient and solvent in formulations, helping to dissolve or carry active ingredients and improve product texture and absorption.
-
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 AVM951ZWST
Ferulic acid is a naturally occurring plant compound used as an antioxidant in medications. It helps prevent ingredient breakdown and maintain product stability during storage.
-
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 12Z59IF64N
Hydrogen dimethicone is a silicone-based fluid that acts as a lubricant and anti-foaming agent in medicines. It helps the product flow smoothly during manufacturing and prevents excess air bubbles from forming.
-
UNII 048B98MT5O
A synthetic oil made by chemically treating plant-derived compounds. It acts as a lubricant and glidant to help the medicine flow smoothly during manufacturing and tablet pressing.
-
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 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 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 SK47B8698T
A mineral compound containing magnesium, sulfate, and water molecules. Used in medicines as a laxative agent and sometimes as a filler or anti-caking ingredient to improve powder flow and stability.
-
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 446U8J075B
Nylon-12 is a synthetic plastic polymer used as a coating or film-forming agent in medicines. It helps create a protective barrier around tablets or capsules to control how and when the medicine is released in the body.
-
UNII 172F2WN8DV
A fatty alcohol derived from animal or plant oils. It acts as an emollient and helps stabilize emulsions, allowing oil and water to mix evenly in the medication.
-
UNII M6U1ZG59XD
A synthetic compound used primarily as a preservative and antimicrobial agent in pharmaceutical formulations. It helps prevent bacterial and fungal growth, extending the product's shelf life.
-
UNII 7F9WLW26M2
A synthetic polymer made from modified starch and glycerin, used as a conditioning agent and thickener. It helps improve texture, spreadability, and feel in topical products like creams and lotions.
-
UNII 1206E8961B
A synthetic moisturizing compound derived from panthenol. It's used in topical formulations as an emollient and skin conditioner to help soften and hydrate the skin surface.
-
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 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 0C143929GK
Phenethyl benzoate is a synthetic fragrance and flavoring agent used in medicines to mask unpleasant tastes or add pleasant aroma to improve patient acceptance of the medication.
-
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 BG58BW230G
A plant extract from golden polypody fern leaves. Used in formulations for its traditional skin-soothing properties and as a natural botanical ingredient to support the product's intended effects on skin health and appearance.
-
UNII W4TKW9D5GG
Physalis angulata is a plant extract used as a natural flavoring or coloring agent in some medicines. It may also serve as a botanical ingredient to support the product's formulation.
-
UNII 8KQ7I65XZE
A waxy compound derived from stearic acid, used as a thickener and emulsifier to help blend oil and water-based ingredients. It improves the texture and stability of the medicine formulation.
-
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 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
-
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.
52 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesWater, Dimethicone, Isododecane, C12-15 Alkyl Benzoate, Hydrogenated Didecene, Butyloctyl Salicylate, Aluminum Hydroxide, Styrene/Acrylates Copolymer, Phenethyl Benzoate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Nylon-12, Calaguala (Polypodium leucotomos) Leaf Extract, Ferulic Acid, 3-O-Ethyl Ascorbic Acid, Tocopheryl Acetate, Tocopherol, Cutleaf Grouncherry (Physalis angulata) Extract, Green Tea (Camellia sinensis) Extract, Plankton (Chlamydomonas reinhardti) Extract, Arginine, Melanin, Caprylyl Glycol, Isohexadecane, Disteardimonium Hectorite, Hydrogen Dimethicone, Phenylpropanol, Polyhydroxystearic Acid, Magnesium Sulfate, Dimethicone/PEG-10/15 Crosspolymer, Propanediol, Triethoxycaprylylsilane, Propylene Carbonate, Caprylic/Capric Triglyceride, Panthenyl Triacetate, Butylene Glycol, Propylene Glycol, Ethyl Linoleate, Oleyl Alcohol, Pentylene Glycol, Oxothiazolidine, Dipropylene Glycol, Sodium Citrate, Palmitoyl Hydroxypropyltrimonium Amylopectin/Glycerin Crosspolymer, 1,2-Hexanediol, Lecithin, Sodium Benzoate, Hydrogenated Lecithin, Phenoxyethanol, Ethylhexylglycerin, Iron Oxides (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77491), Ferrosoferric 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 system | Per g | Per 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
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| toty Solaria Mineral 7 g/100g; 6 g/100gthis 82141-3161-03 | Chipican | 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
Jun 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 Titanium Dioxide, Zinc Oxide — the ingredient across all brands.
Top reported reactions
Reporter sex
Male · 24%
Female · 76%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 82141-3161-01 | 1 TUBE in 1 CARTON (82141-3161-1) / 50 g in 1 TUBE | 2023-06-01 | Discontinued by firm |
| 82141-3161-02 | 1 TUBE in 1 CARTON (82141-3161-2) / 5 g in 1 TUBE | 2023-06-01 | Active |
| 82141-3161-03 You're viewing this | 1 BOTTLE in 1 CARTON (82141-3161-3) / 30 g in 1 BOTTLE | 2024-01-08 | Active |
| 82141-3161-04 | 1 BOTTLE in 1 CARTON (82141-3161-4) / 50 g in 1 BOTTLE | 2023-06-01 | Active |
Pack size FAQ
What quantity is in NDC 82141-3161-03?
NDC 82141-3161-03 is listed by the FDA — 1 bottle in 1 carton / 30 g in 1 bottle.
What NDC number is used to bill for this package of toty Solaria Mineral Titanium Dioxide, Zinc Oxide 7 g/100g; 6 g/100g Cream?
Bill NDC 82141-3161-03 — the 11-digit billing format is 82141316103. 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 82141-3161-3, 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: 82141-3161-03, written without dashes as 82141316103. 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 82141-3161-03, the first segment (82141) is the labeler code FDA assigned to Chipican LLC; the middle segment (3161) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Chipican 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 3 other package presentations of this same product, including 1 tube (82141-3161-01), 1 tube (82141-3161-02), 1 bottle (82141-3161-04). 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?
Chipican 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
⏱️ Dosage and Administration
⚠️ Warnings
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
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 ▾
Directions Shake well before use Apply liberally 15 minutes before sun exposure Reapply: After 80 minutes of swimming or sweating Immediately after towel drying At least every 2 hours 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 10 a.m. - 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: Ask a doctor
⚠️ Warnings ▾
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
📦 Storage and Handling ▾
Other information Do not expose the product to high temperatures Protect the product in this container from excessive heat and direct sun
🧪 Active Ingredient ▾
Active Ingredients Titanium Dioxide 7.0% Zinc Oxide 6.0%
🧪 Inactive Ingredients ▾
Inactive Ingredients Water, Dimethicone, Isododecane, C12-15 Alkyl Benzoate, Hydrogenated Didecene, Butyloctyl Salicylate, Aluminum Hydroxide, Styrene/Acrylates Copolymer, Phenethyl Benzoate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Nylon-12, Calaguala ( Polypodium leucotomos ) Leaf Extract, Ferulic Acid, 3-O-Ethyl Ascorbic Acid, Tocopheryl Acetate, Tocopherol, Cutleaf Grouncherry (Physalis angulata) Extract, Green Tea ( Camellia sinensis) Extract, Plankton ( Chlamydomonas reinhardti ) Extract, Arginine, Melanin, Caprylyl Glycol, Isohexadecane, Disteardimonium Hectorite, Hydrogen Dimethicone, Phenylpropanol, Polyhydroxystearic Acid, Magnesium Sulfate, Dimethicone/PEG-10/15 Crosspolymer, Propanediol, Triethoxycaprylylsilane, Propylene Carbonate, Caprylic/Capric Triglyceride, Panthenyl Triacetate, Butylene Glycol, Propylene Glycol, Ethyl Linoleate, Oleyl Alcohol, Pentylene Glycol, Oxothiazolidine, Dipropylene Glycol, Sodium Citrate, Palmitoyl Hydroxypropyltrimonium Amylopectin/Glycerin Crosspolymer, 1,2-Hexanediol, Lecithin, Sodium Benzoate, Hydrogenated Lecithin, Phenoxyethanol, Ethylhexylglycerin, Iron Oxides (Ferric Oxide Red (CI 77491), Ferric Oxide Yellow (CI 77491), Ferrosoferric Oxide (CI 77499)).
🎯 Purpose ▾
Purpose Sunscreen
No label section mentions that — try another word, or open the full label on DailyMed below.
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.