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Eezysun SPF 50 Titanium Dioxide, Zinc Oxide 8 g/100mL; 10 g/100mL Cream

by BIO EARTH MANUFACTURING (PTY) LTD · 70 TUBE in 1 CARTON (70116-014-01) / 100 mL in 1 TUBE
NDC 70116-0014-01
🏷️ FDA NDC (as labeled) 70116-014-01 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ 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 →

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 ↗
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 70116-014-01
Product NDC 70116-014
11-digit billing NDC 70116001401
UNII 15FIX9V2JP, SOI2LOH54Z
Application # M020
SPL Set ID 6bfc7930-ee0a-46b0-9018-cf59a9dfcf34
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2023-06-30
Route TOPICAL
Dosage form CREAM
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 70116-014-01 — 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 → 70116-0014-01. 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

LabelerBIO EARTH MANUFACTURING (PTY) LTD
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code70116
First marketedJun 2023
Product typeHuman Otc Drug
Portfolio4 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?

Eezysun SPF 50 is a topical cream sold as an over-the-counter sunscreen product under FDA's OTC monograph rules. It contains titanium dioxide and zinc oxide, which are mineral UV filters commonly used to reflect and scatter ultraviolet rays from the sun. These inorganic active ingredients are typically found in physical sunscreen formulations applied to the skin to help protect against sun exposure.

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 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 PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII 4DKJ9B3K2T
    A natural oil derived from neem tree seeds, used in medicines as an emollient and skin-conditioning agent to help soften and protect the product's texture.
  • UNII 25BB7EKE2E
    Barium sulfate is a white powder mineral compound used as a filler and opacifying agent in tablets and capsules. It adds bulk to the medicine and may be included in formulations for imaging purposes.
  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • 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 09FUA47KNA
    Cetearyl glucoside is a plant-derived surfactant made from vegetable oils and glucose. It helps oils and water mix together in creams and lotions, and can also soften and smooth the skin feel of the product.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • 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 QYO8Q067D0
    Citronella oil is a natural plant-derived oil used as a fragrance and flavoring agent in medicines. It provides taste and aroma to make medications more palatable for patients.
  • UNII 4C38SS0J60
    A fragrant oil extracted from lemon flower tops, used as a flavoring and aromatic agent to improve the taste and smell of the medicine.
  • UNII 06JMS448M5
    A plant extract from lemongrass leaves used in medicines as a flavoring agent and fragrance component. It adds taste and aroma to make the product more pleasant to take.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII ZF94AP8MEY
    Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
  • UNII T4V6TWG28D
    A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII 03KCY6P7UT
    A waxy compound derived from cetyl alcohol and phosphoric acid. It acts as an emulsifier to help blend oil and water ingredients, and as a thickener to give the medicine its proper texture and consistency.
  • 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 J99W255AWF
    A plant-derived oil from rosehip seeds used as an emollient and skin-conditioning agent. It helps soften the product and improve how it spreads on skin or mucous membranes.
  • 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 TU7HW0W0QT
    A salt derived from lactic acid, sodium lactate acts as a buffer and pH stabilizer in medicines. It helps maintain the product's acidity level and can also serve as a humectant to retain moisture.
  • UNII 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
  • UNII 0A3F415158
    A flavoring extract from vanilla bean fruit that gives medicine a pleasant vanilla taste and aroma. It masks bitter or unpleasant flavors to make the medicine easier to take.
  • UNII 1D1K0N0VVC
    A fat-soluble form of vitamin A used as a colorant and nutritional fortification ingredient. It gives products a yellow or orange tint and increases vitamin A content in the formula.
  • 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.

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

The official label also statesAloe Barbadensis Leaf Oil, Aqua, Ascorbic Acid, Baryte,Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Citronella,Citrullus Vulgaris (Kalahari Melon) Oil, Glycerine, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Hydroxyethyl Cellulose,Lemongrass, Neem, Polysorbate 20, Potassium Cetyl Phosphate, Potassium Sorbate, Retinol Palmitate, Ricinus Communis (Castor) Seed Oil (and) Hydrogenated Castor Oil (and) Copernicia Cerifera (Carnauba) Wax, Rosa Mosqueta (Rosehip) Fruit, Sodium Benzoate, Sodium Lactate, Sorbitan Olivate, Tocopheryl Acetate, Vanilla Planifolia Fruit Oil

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
Eezysun SPF 50 Baby and Kids 8 g/100mL; 10 g/100mL 70116-0026-01 BIO 1 tube — — Discontinued —
Eezysun SPF 50 8 g/100mL; 10 g/100mLthis 70116-0014-01 BIO 70 tubes — — Discontinued —
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

Exposure To Toxic Agent7
Product Contamination Chemical5
Acute Myeloid Leukaemia4
Malignant Melanoma4
Neoplasm Malignant4
Sunburn4
Application Site Rash3

Age at onset

Child1
Adolescent1
Adult7
Elderly2

Reporter sex

44 reports
Male · 24%
Female · 76%

Serious outcomes

Hospitalization7
Death2
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 11 1
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
70116-0014-01 You're viewing this 70 TUBE in 1 CARTON (70116-014-01) / 100 mL in 1 TUBE 2023-06-30 Inactivated by FDA

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 70116-014-01, 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: 70116-0014-01, written without dashes as 70116001401. 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 70116-0014-01, the first segment (70116) is the labeler code FDA assigned to BIO EARTH MANUFACTURING (PTY) LTD; the middle segment (0014) 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.
Who lists this product with the FDA?
BIO EARTH MANUFACTURING (PTY) LTD 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 27 words ▾

Uses Helps prevent sunburn and protects against insects If used as directed with other sun protection measures ( See Directions ) decreases the risk of skin cancer

⏱️ Dosage and Administration 73 words ▾

Direction 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. Use a broad spectrum sun-screen with an SPF value of 50 or higher limit time in the sun, especially from 10 am - 2 pm wear long-sleeve shirts, pants, hats and sunglasses Children under 6 months of age: ask a doctor Shake well before use

⚠️ Warnings 40 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 doctor if rash occurs Keep out of reach of children

🧪 Active Ingredient 8 words ▾

Active ingredients Zinc Oxide 10%, Titanium Dioxide 8%

🧪 Inactive Ingredients 69 words ▾

Inactive ingredients Aloe Barbadensis Leaf Oil, Aqua, Ascorbic Acid, Baryte,Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Citronella,Citrullus Vulgaris (Kalahari Melon) Oil, Glycerine, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Hydroxyethyl Cellulose,Lemongrass, Neem, Polysorbate 20, Potassium Cetyl Phosphate, Potassium Sorbate, Retinol Palmitate, Ricinus Communis (Castor) Seed Oil (and) Hydrogenated Castor Oil (and) Copernicia Cerifera (Carnauba) Wax, Rosa Mosqueta (Rosehip) Fruit, Sodium Benzoate, Sodium Lactate, Sorbitan Olivate, Tocopheryl Acetate, Vanilla Planifolia Fruit Oil

🎯 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 ↗
← 70115-0007-01 · Eskay 70116-0025-01 · BIO →
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.