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Extreme Protect SPF 40 All Shades Zinc Oxide, Titanium Dioxide 1.3 g/100g; 15.3 g/100g Cream — NDC 69219-0108-31 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Extreme Protect SPF 40 All Shades Zinc Oxide, Titanium Dioxide 1.3 g/100g; 15.3 g/100g Cream — NDC 69219-108-31 (Billing 69219-0108-31)

by Science of Skincare, LLC. · 1 BOTTLE, PLASTIC in 1 BOX / 240 g in 1 BOTTLE, PLASTIC

This is a package of Extreme Protect SPF 40 All Shades Zinc Oxide, Titanium Dioxide 1.3 g/100g; 15.3 g/100g Cream from Science of Skincare, LLC., marketed since Mar 2021 and currently FDA-listed.

NDC 69219-0108-31
🏷️ FDA NDC (as labeled) 69219-108-31 billing pads the product segment with a zero
This package
Contains240 g in 1 bottle, plastic Pack sizes5 compare ↓
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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) 69219-108-31
Product NDC 69219-108
11-digit billing NDC 69219010831
UNII 15FIX9V2JP, SOI2LOH54Z
UPC 0817244011675, 0817244011668, 0817244011682
Application # M020
SPL Set ID b69db78b-5f0e-8ca2-e053-2a95a90ac88c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-03-01
Route TOPICAL
Dosage form CREAM
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 69219-108-31 — 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 → 69219-0108-31. 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?

Extreme Protect SPF 40 All Shades is a topical cream sunscreen marketed as an over-the-counter monograph product. It contains titanium dioxide and zinc oxide, which are mineral UV filters commonly used in sunscreens to help block ultraviolet radiation from the sun. These ingredients function as physical barriers that reflect and scatter UV rays away from the skin. This product is typically applied to exposed skin to help provide sun protection.

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.
Try another pack size: 100 g 5 g 100 g 240 g
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
69219-0108-01 69219-108-01 Main listing 100 g in 1 BOTTLE, PLASTIC 2021-04-01 — Active
69219-0108-03 69219-108-03 240 g in 1 BOTTLE, PLASTIC 2021-04-01 — Active
69219-0108-11 69219-108-11 1 BOTTLE, PLASTIC in 1 BOX / 100 g in 1 BOTTLE, PLASTIC 2021-04-01 — Active
69219-0108-21 69219-108-21 1 BOTTLE, PLASTIC in 1 BAG / 5 g in 1 BOTTLE, PLASTIC 2021-03-02 — Active
69219-0108-31 You're viewing this 1 BOTTLE, PLASTIC in 1 BOX / 240 g in 1 BOTTLE, PLASTIC 2021-03-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, plastic in 1 box / 240 g in 1 bottle, plastic.
What NDC number is used to bill for this package of Extreme Protect SPF 40 All Shades Zinc Oxide, Titanium Dioxide 1.3 g/100g; 15.3 g/100g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Extreme Protect SPF 40 All Shades 1.3 g/100g; 15.3 g/100gthis 69219-0108-31 Science 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

🏛️
2021
On the market since
Mar 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 A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 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 U6XF9NP8HM
    Aluminum stearate is a salt made from aluminum and stearic acid, a fatty substance. It works as a lubricant and glidant to help powder flow smoothly during manufacturing and tablet production.
  • UNII 9PA5A687X5
    Asiatic acid is a natural compound extracted from plants that acts as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product's texture while supporting skin hydration.
  • UNII PKO39VY215
    A natural compound derived from Centella asiatica plant, used as an active botanical extract or skin-conditioning agent in topical formulations to support ingredient stability and product efficacy.
  • 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 N7YC58165T
    A synthetic polymer made from glycerin and sebacic acid, used as a film-former and binder in medications. It helps hold tablet or capsule ingredients together and may coat the product for controlled release.
  • 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 RO266O364U
    Dimethicone is a silicone-based lubricant and anti-foaming agent. It reduces friction between particles and prevents foam formation in liquid or semi-solid medicines, helping with smooth mixing and texture.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 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 4CG9F9W01Q
    A synthetic fatty acid ester used as an emollient and skin-conditioning agent in topical medicines. It helps soften the product texture and improves how it spreads and absorbs into the skin.
  • UNII X33R8U0062
    Isostearic acid is a fatty acid derived from vegetable oils. It acts as an emulsifier and lubricant in medicines, helping blend ingredients together and reducing friction during tablet or capsule manufacturing.
  • UNII M7O1N24J82
    Madecassic acid is a natural compound extracted from Centella asiatica plant. In medications, it acts as an active pharmaceutical ingredient or functional excipient that may support skin health and wound healing in topical formulations.
  • UNII 6M3P64V0NC
    A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
  • 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 MJ95C3OH47
    A plant extract from olive leaves used in formulations as an antioxidant and preservative. It helps protect the medicine from degradation and extend shelf life.
  • 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 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 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 820DPX33S7
    A synthetic emulsifier derived from glycerin and fatty acids. It helps mix oil and water-based ingredients together and keeps them evenly blended throughout the product.
  • 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 0L414VCS5Y
    A synthetic polymer used as a film-former and conditioning agent. It helps create a protective coating on hair or skin surfaces and improves texture and manageability in topical formulations.
  • UNII 77KA3O6NNF
    A synthetic plastic material used in pharmaceutical coatings and film formulations. It provides structural strength and flexibility to tablet or capsule coatings, helping protect the medicine and control how it dissolves in the body.
  • 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 NVZ4I0H58X
    A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
  • 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 8OC9U7TQZ0
    Tribehenin is a waxy, plant-derived substance that acts as a lubricant and glidant in tablets and capsules. It helps the medicine flow smoothly during manufacturing and prevents sticking during production and packaging.
  • UNII 3T5PCR2H0C
    A synthetic detergent and emulsifier made from plant-derived materials. It helps mix oil and water components together and improves how the medicine spreads or absorbs in the body.
  • 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.

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

The official label also statesWater/Aqua/Eau, Zinc Oxide, C12-15 Alkyl Benzoate, Glycerin, Caprylic Capric Triglycerides, Tocopherol, Sorbitan Stearate, Panthenyl Triacetate, Titanium Dioxide, Pentylene Glycol, Ethyl Linoleate, Polyhydroxystearic Acid, Tribehenin, Polyurethane-62, Ethylhexylglycerin, Polyglyceryl-4 Isostearate, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Oleyl Alcohol, Xanthan Gum, Aluminum Stearate, Propylene Glycol, Asiaticoside, Asiatic Acid, Madecassic Acid, Alumina, Olea Europaea (Olive) Leaf Extract, Sorbitol/Sebacic Acid Copolymer Behenate, Magnesium Aluminum Silicate, Trideceth-6, Phenoxyethanol, Aloe Barbadensis Leaf Juice, Isostearic Acid, Disodium EDTA, Polyquaternium-7, +/- CI 77491, CI 77492, CI 77499 *May contain one or more of these ingredients

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

LabelerScience of Skincare, LLC.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code69219
First marketedMar 2021
Product typeHuman Otc Drug
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 27 words ▾

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 83 words ▾

Apply liberally 15 minutes before sun exposure. Reapply: After 40 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 10am - 2pm. wear long-sleeve shirts, pants, hats, and sunglasses.

⚠️ Warnings 4 words ▾

For external use only.

🧪 Active Ingredient 6 words ▾

Zinc Oxide: 15.3% Titanium Dioxide: 1.3%

🧪 Inactive Ingredients 87 words ▾

Water/Aqua/Eau, Zinc Oxide, C12-15 Alkyl Benzoate, Glycerin, Caprylic Capric Triglycerides, Tocopherol, Sorbitan Stearate, Panthenyl Triacetate, Titanium Dioxide, Pentylene Glycol, Ethyl Linoleate, Polyhydroxystearic Acid, Tribehenin, Polyurethane-62, Ethylhexylglycerin, Polyglyceryl-4 Isostearate, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Oleyl Alcohol, Xanthan Gum, Aluminum Stearate, Propylene Glycol, Asiaticoside, Asiatic Acid, Madecassic Acid, Alumina, Olea Europaea (Olive) Leaf Extract, Sorbitol/Sebacic Acid Copolymer Behenate, Magnesium Aluminum Silicate, Trideceth-6, Phenoxyethanol, Aloe Barbadensis Leaf Juice, Isostearic Acid, Disodium EDTA, Polyquaternium-7, +/- CI 77491, CI 77492, CI 77499 *May contain one or more of these ingredients

🎯 Purpose 1 words ▾

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 9 words ▾

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 swallowed, get medical help or contact a Poison Control Center right away.

📄 Other Information 9 words ▾

Protect this product from excessive heat and direct sun.

📄 Questions or Comments 8 words ▾

Call Customer Care at (888) 804 - 4447

📄 Package Label / Principal Display Panel 31 words ▾

69219-108-21 5g 10 pack 69219-108-01 Bronze 100g bottle 69219-108-11 Beige Box 69219-108-01 Beige 100g bottle 69219-108-01 NT 100g bottle 69219-108-02 5g single 69219-108-11 NT Box 69219-108-11 Bronze 100g box 69219-108-03 69219-108-31

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 Science of Skincare, 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 4 other package presentations of this same product, including 1 bottle (69219-0108-11), 1 bottle (69219-0108-21), 100 g (69219-0108-01). 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?
Science of Skincare, 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.
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.