HomeNDC LookupIngredientsZinc Oxide, Octinoxate › 72957-0015-01
Sheer Defense Tinted Broad Spectrum Sunscreen SPF 50 Zinc Oxide, Octinoxate 12 g/100g; 7.5 g/100g Cream, 57 g — NDC 72957-0015-01 package photo

Sheer Defense Tinted Broad Spectrum Sunscreen SPF 50 Zinc Oxide, Octinoxate 12 g/100g; 7.5 g/100g Cream, 57 g

by Private Label Skin Care · 57 g in 1 BOTTLE, PUMP (72957-015-01)
NDC 72957-0015-01
🏷️ FDA NDC (as labeled) 72957-015-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 72957-015-01
Product NDC 72957-015
11-digit billing NDC 72957001501
UNII SOI2LOH54Z, 4Y5P7MUD51
Application # M020
SPL Set ID 9eb7f287-cb61-4f9d-968e-16b195dbbc9a
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-20
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE; OCTINOXATE
Why two NDCs? The FDA registers this code as 72957-015-01 — 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 → 72957-0015-01. 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.

🏭 Manufacturer & labeler

LabelerPrivate Label Skin Care
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code72957
First marketedMay 2026
Product typeHuman Otc Drug
Portfolio13 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?

Sheer Defense Tinted Broad Spectrum Sunscreen SPF 50 is a topical cream sold over the counter as an OTC monograph product. It contains zinc oxide and octinoxate, both ultraviolet (UV) filters commonly used in sunscreen products to help protect skin from sun damage. This tinted formulation is applied to exposed skin to provide broad-spectrum coverage against both UVA and UVB 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.

🧪 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 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 LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • UNII ZRA72DR3R7
    A waxy substance made from fatty acids and glycerin that acts as a binder and lubricant in tablets and capsules. It helps hold ingredients together and makes the medicine easier to swallow.
  • UNII UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • UNII E00JL9G9K0
    A plant-derived cleaning agent made from coconut oil and natural sugars. It works as a solubilizer and emulsifier to help mix water and oil-based ingredients together in the medicine.
  • UNII GSA2TXZ34G
    A synthetic polymer made from castor oil and a chemical linker, used as a coating or binder in medications to control how and when the active ingredient is released in the body.
  • 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 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 Z17H97EA6Y
    A plant-derived mild cleanser made from natural sugars and oils. It acts as an emulsifier and surfactant to help mix water and oil-based ingredients together in the medicine.
  • UNII 1F2S8T535O
    A synthetic polymer made from fatty acids and a chemical compound that binds ingredients together. It works as a binder and film-former in solid dosage forms, helping hold tablets together and coat their surface.
  • 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 45ASM2L11M
    A synthetic ingredient derived from glutamic acid and stearic acid. It acts as an emulsifier and surfactant, helping oils and water mix smoothly in the medication 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 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 TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • 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 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 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII DNR46JQ8BT
    Phenylsilanetriol is a silicon-based compound used in pharmaceutical formulations as a glidant and anti-caking agent. It helps powders flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 598RES7AXX
    A synthetic emulsifier derived from glycerin and oleic acid. It helps mix oil and water components in formulations, improving texture and stability of creams, lotions, or suspensions.
  • UNII G4AYJ54K59
    A plant-derived emulsifier made from glycerin and oleic acid. It helps mix oil and water-based ingredients together and keeps them blended throughout the product's shelf life.
  • UNII YPM0ZOC2HR
    A synthetic emulsifier derived from glycerin and castor oil. It helps mix oil and water-based ingredients together in the formulation to create a uniform product and improve texture.
  • UNII ZCD6009IUF
    A plant-derived ingredient from knotweed used as a natural filler and binding agent. It helps hold the medicine's ingredients together and add bulk to tablets or capsules.
  • 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 X2PZH4Y6HT
    A silicone-based powder derived from silicon and oxygen compounds. It works as a glidant and anti-caking agent to improve how the tablet or capsule flows during manufacturing and prevent clumping in the finished product.
  • 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 BMT4RCZ3HG
    Sodium cocoyl glutamate is a mild cleanser derived from coconut oil and amino acids. It's used in medicines as a surfactant to help dissolve and distribute active ingredients evenly throughout the formulation.
  • UNII HBD7CC5UGF
    A bacterial-derived compound used as an emulsifier and surfactant to help mix oil and water components together in medications and improve how the product spreads or dissolves.
  • 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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 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.

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

The official label also statesWater/Aqua/Eau, Isododecane, Dimethicone, Propanediol, Polyglyceryl-6 Polyricinoleate, Niacinamide, Polymethylsilsesquioxane/ Trimethylsiloxysilicate, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, C12-15 Alkyl Benzoate, Polyglyceryl-10 Dioleate, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyphenylsilsesquioxane, Lecithin, Polysilicone-11, Polyhydroxystearic Acid, 1,2-Hexanediol, Shea (Butyrospermum Parkii) Butter, C18-36 Acid Triglyceride, Tribehenin, Disteardimonium Hectorite, Glycerin, Sodium Hyaluronate, Propylene Carbonate, Aminomethyl Propanol, Caprylhydroxamic Acid, Caprylyl/Capryl Glucoside, Triethoxycaprylylsilane, Castor Oil/IPDI Copolymer, Dilinoleic Acid/Butanediol Copolymer, Disodium Stearoyl Glutamate, Decyl Glucoside, Sodium Cocoyl Glutamate, Glyceryl Caprylate, Citric Acid, Polyglyceryl-6 Oleate, Polygonum Aviculare Extract, Sodium Surfactin, Titanium Dioxide CI 77891, Iron Oxide (CI 77492), Iron Oxide (CI 77491), Iron 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 DailyMedingredient 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.
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
Clear Defense SPF 45 12 g/100g; 7.5 g/100g 72957-0003-01 Private 57 g FDA listed
Sheer Defense Tinted SPF 46 12 g/100g; 7.5 g/100g 72957-0002-01 Private 57 g FDA listed
Broad Spectrum SPF45 12 g/100g; 7.5 g/100g 83286-0008-01 Drmtlgy, 57 g FDA listed
Sheer Defense Tinted Broad Spectrum Sunscreen SPF 50 12 g/100g; 7.5 g/100gthis 72957-0015-01 Private 57 g 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

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 Zinc Oxide, Octinoxate — the ingredient across all brands.

Top reported reactions

Posture Abnormal3
Eye Movement Disorder2
Feeling Abnormal2
Petit Mal Epilepsy2
Seizure2
Staring2
Aggression1

Reporter sex

0 reports
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 7 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
72957-0015-01 You're viewing this 57 g in 1 BOTTLE, PUMP (72957-015-01) 2026-05-20 Active

🧭 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 72957-015-01, 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: 72957-0015-01, written without dashes as 72957001501. 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 72957-0015-01, the first segment (72957) is the labeler code FDA assigned to Private Label Skin Care; the middle segment (0015) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Private Label Skin Care. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Private Label Skin Care 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 32 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 113 words

Directions • Apply liberally on a clean dry face, avoiding delicate eye area 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 57 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 15 words

Other information • protect the product in this container from excessive heat and direct sun

🧪 Active Ingredient 7 words

Active ingredient Zinc Oxide 12% Octinoxate 7.5%

🧪 Inactive Ingredients 91 words

Inactive ingredients Water/Aqua/Eau, Isododecane, Dimethicone, Propanediol, Polyglyceryl-6 Polyricinoleate, Niacinamide, Polymethylsilsesquioxane/ Trimethylsiloxysilicate, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, C12-15 Alkyl Benzoate, Polyglyceryl-10 Dioleate, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyphenylsilsesquioxane, Lecithin, Polysilicone-11, Polyhydroxystearic Acid, 1,2-Hexanediol, Shea (Butyrospermum Parkii) Butter, C18-36 Acid Triglyceride, Tribehenin, Disteardimonium Hectorite, Glycerin, Sodium Hyaluronate, Propylene Carbonate, Aminomethyl Propanol, Caprylhydroxamic Acid, Caprylyl/Capryl Glucoside, Triethoxycaprylylsilane, Castor Oil/IPDI Copolymer, Dilinoleic Acid/Butanediol Copolymer, Disodium Stearoyl Glutamate, Decyl Glucoside, Sodium Cocoyl Glutamate, Glyceryl Caprylate, Citric Acid, Polyglyceryl-6 Oleate, Polygonum Aviculare Extract, Sodium Surfactin, Titanium Dioxide CI 77891, Iron Oxide (CI 77492), Iron Oxide (CI 77491), Iron Oxide (CI 77499)

🎯 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 ↗
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.