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Blue Lizard Sheer SPF 50 Sunscreen Titanium Dioxide, Zinc Oxide 66.6 mg/mL; 99.9 mg/mL Lotion — NDC 00316-2064-30 package photo

Blue Lizard Sheer SPF 50 Sunscreen Titanium Dioxide, Zinc Oxide 66.6 mg/mL; 99.9 mg/mL Lotion

by Crown Laboratories · 1 TUBE in 1 CARTON (0316-2064-30) / 89 mL in 1 TUBE
NDC 00316-2064-30
🏷️ FDA NDC (as labeled) 0316-2064-30 billing pads the labeler 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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) 0316-2064-30
Product NDC 0316-2064
11-digit billing NDC 00316206430
UNII SOI2LOH54Z, 15FIX9V2JP
Application # M020
SPL Set ID c20fce25-8120-fe5d-e053-2a95a90a53a0
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-05-06
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 0316-2064-30 — a 4-4-2 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 labeler segment → 00316-2064-30. 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

LabelerCrown Laboratories
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code00316
First marketedMay 2021
Product typeHuman Otc Drug
Portfolio43 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?

Blue Lizard Sheer SPF 50 is a topical lotion sunscreen marketed as an over-the-counter monograph product. It contains zinc oxide and titanium dioxide, which are mineral UV filters commonly used in sunscreens to reflect and scatter ultraviolet rays away from the skin. These physical blockers are typically applied to exposed skin as part of sun protection routines. This product is formulated as a lotion for easy topical application.

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.

🧪 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 I1XGH66S8P
    A naturally-derived liquid compound used as a flavoring agent in medicines. It provides a creamy, coconut-like taste to mask bitter drug flavors and improve how the medication tastes to patients.
  • 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 D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
  • 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 J7IHY79BKY
    A plant extract from glasswort, a coastal herb. It's used in formulations as a humectant to help retain moisture and may serve as a skin-conditioning agent in topical products.
  • UNII YY7C30VXJT
    A natural plant extract from cucumber that adds flavor and freshness to medicines. It may also serve as a moisturizing agent or mild preservative in topical or oral formulations.
  • UNII J8T3X564IH
    A clear oily liquid derived from sebacic acid, used as a plasticizer and solvent in pharmaceutical coatings and films to improve flexibility and help active ingredients dissolve properly.
  • UNII 02QB6788GC
    A silicone compound used as a glidant and anti-caking agent in powdered medicines. It reduces friction between particles so the powder flows smoothly during manufacturing and tablet pressing.
  • 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 535G2ABX9M
    Fucus vesiculosus is a brown seaweed that serves as a thickener, binder, and emulsifier in medicines. It helps create smooth texture and hold ingredients together in liquid and semi-solid formulations.
  • UNII 19FUJ2C58T
    Ginkgo biloba leaf is a plant extract used as a flavoring or coloring agent in some medicines. It may also serve as a natural ingredient to support the product's formulation.
  • 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 T07U1161SV
    A plant extract from witch hazel leaves, used in medicines as a natural astringent and skin-soothing agent. It helps reduce irritation and is often included in topical formulations for its mild anti-inflammatory properties.
  • UNII 257THB963H
    A solid fat made from palm oil that has been chemically processed to increase stability. It functions as a binder and lubricant in tablets and capsules to help hold ingredients together and improve how the medicine flows during manufacturing.
  • UNII K168T6Y0YU
    A plant-based oil derived from rapeseed that has been chemically treated to make it solid at room temperature. It acts as a binder, lubricant, and coating agent to help hold tablet ingredients together and improve how the medicine flows during manufacturing.
  • UNII Q613OCQ44Y
    Isostearyl alcohol is a fatty alcohol derived from plant or petroleum sources. It acts as an emollient and thickener in formulations, helping to soften the product and improve texture and stability.
  • UNII IV0Z586Z4Y
    A synthetic oil derived from isostearic acid, used as an emollient and lubricant in topical formulations to soften the skin and improve the texture and spreadability of creams, lotions, and ointments.
  • 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 TI9T76XD44
    A natural flavoring derived from orange fruit peel. It adds orange taste and aroma to the medicine, making it more pleasant to take, while also providing natural color.
  • UNII KU94FIY6JB
    A natural enzyme extract from papaya fruit that helps break down proteins. It's used in some medicines as a digestive aid ingredient and may help tablets dissolve or break apart in the stomach.
  • 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 7Q0OK5DOT4
    A plant-derived emulsifier made from glycerin and ricinoleic acid (from castor oil). It helps blend oil and water-based ingredients together in formulations and improves product texture and stability.
  • 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 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII CR7307M3QZ
    Rosa canina fruit oil is a natural oil extracted from rosehip fruit. It's used in medicines as an emollient and skin-conditioning agent to help soften and smooth the product's texture or skin contact surface.
  • UNII WDO4TLS35F
    A plant-based oil extracted from marula tree seeds, used as an emollient and skin-conditioning agent in topical formulations to help soften and protect the skin surface.
  • 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 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 01S2G2C1E4
    Sorbitan isostearate is an emulsifier derived from sorbitol and isostearic acid. It helps mix oil and water-based ingredients together and keeps them blended throughout the medicine's shelf life.
  • 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 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 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
  • 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.

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

The official label also statesAloe Barbadensis Leaf Juice, Alumina, Aluminum Stearate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Carica Papaya (Papaya) Fruit Extract, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Extract, Crithmum Maritimum Extract, Cucumis Sativus (Cucumber) Fruit Extract, Diisopropyl Sebacate, Dimethoxydiphenylsilane/Triethoxycaprylylsilane Crosspolymer, Ethylhexylglycerin, Fucus Vesiculosus (Bladderwrack) Extract, Gamma-Nonalactone, Ginkgo Biloba (Ginkgo) Leaf Extract, Glycerin, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Hydrogenated Vegetable Oil, Isostearyl Alcohol, Isostearyl Isostearate, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Potassium Sorbate, Purified Water, Ricinus Communis (Castor) Seed Oil, Rosa Canina (Rosehip) Fruit Oil, Sclerocarya Birrea (Marula) Seed Oil, Sea Water, Sodium Benzoate, Sodium Chloride, Sorbitan Isostearate, Squalane, Tocopheryl Acetate (Vitamin E), Triethyl Citrate, and Xanthan Gum

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.
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
Blue Lizard Sheer SPF 50 Sunscreen 66.6 mg/mL; 99.9 mg/mLthis 00316-2064-30 Crown 1 tube — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2021
On the market since
May 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00316-2064-30 You're viewing this 1 TUBE in 1 CARTON (0316-2064-30) / 89 mL in 1 TUBE 2021-05-06 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 0316-2064-30, 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: 00316-2064-30, written without dashes as 00316206430. 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 00316-2064-30, the first segment (00316) is the labeler code FDA assigned to Crown Laboratories; the middle segment (2064) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 Crown Laboratories. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Crown Laboratories 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 42 words ▾

Uses Helps prevent sunburn and photodamage caused by UVA/UVB exposure Higher SPF gives more sunburn protection 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 121 words ▾

Directions Shake well prior to use Apply liberally to dry skin 15 minutes before sun exposure For topical use only Keep out of reach of children Children under 6 months: ask a doctor Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF 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.

Reapply to dry skin : after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Keep out of reach of children

⚠️ Warnings 49 words ▾

Warnings When using this product Keep out of eyes. Rinse with water to remove Stop use and ask a doctor if Rash or irritation occurs Do not use On damaged or broken skin If allergic to any ingredient If swallowed, get medical help or contact a Poison Control Center

🧪 Active Ingredient 8 words ▾

Active Ingredients Titanium Dioxide 9% Zinc Oxide 6%

🧪 Inactive Ingredients 110 words ▾

Inactive Ingredients Aloe Barbadensis Leaf Juice, Alumina, Aluminum Stearate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Carica Papaya (Papaya) Fruit Extract, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Extract, Crithmum Maritimum Extract, Cucumis Sativus (Cucumber) Fruit Extract, Diisopropyl Sebacate, Dimethoxydiphenylsilane/Triethoxycaprylylsilane Crosspolymer, Ethylhexylglycerin, Fucus Vesiculosus (Bladderwrack) Extract, Gamma-Nonalactone, Ginkgo Biloba (Ginkgo) Leaf Extract, Glycerin, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Hydrogenated Vegetable Oil, Isostearyl Alcohol, Isostearyl Isostearate, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Potassium Sorbate, Purified Water, Ricinus Communis (Castor) Seed Oil, Rosa Canina (Rosehip) Fruit Oil, Sclerocarya Birrea (Marula) Seed Oil, Sea Water, Sodium Benzoate, Sodium Chloride, Sorbitan Isostearate, Squalane, Tocopheryl Acetate (Vitamin E), Triethyl Citrate, and Xanthan Gum

🎯 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 ↗
← 00316-2062-30 · Crown 00316-2074-05 · Crown →
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.