Home › NDC Lookup › Ingredients › Titanium Dioxide Zinc Oxide › 83531-0499-00
KOVR All-Natural SPF-30 Moisturizing Sunscreen for Women TITANIUM DIOXIDE, ZINC OXIDE 60 mg/mL; 60 mg/mL Cream, 118 mL — NDC 83531-0499-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

KOVR All-Natural SPF-30 Moisturizing Sunscreen for Women TITANIUM DIOXIDE, ZINC OXIDE 60 mg/mL; 60 mg/mL Cream, 118 mL — NDC 83531-499-00 (Billing 83531-0499-00)

by ACTIVE LIFE INC · 118 mL in 1 BOTTLE

This is a package of 118 mL of KOVR All-Natural SPF-30 Moisturizing Sunscreen for Women TITANIUM DIOXIDE, ZINC OXIDE 60 mg/mL; 60 mg/mL Cream from ACTIVE LIFE INC, marketed since Jun 2023 and currently FDA-listed. It is this product's only package size.

NDC 83531-0499-00
🏷️ FDA NDC (as labeled) 83531-499-00 billing pads the product segment with a zero
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 →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 83531-499-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
83531 labeler · 499 product · 00 package
Package marketed since
Jun 19, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8353149900 1
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83531-499-00
Product NDC 83531-499
11-digit billing NDC 83531049900
UNII 15FIX9V2JP, SOI2LOH54Z
Application # M020
SPL Set ID 0ddc3bb9-595e-4ebd-ad3e-df4d94fd34ed
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 2023-06-19
Route TOPICAL
Dosage form CREAM
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 83531-499-00 — 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 → 83531-0499-00. 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?

KOVR All-Natural SPF-30 Moisturizing Sunscreen for Women is a topical cream containing titanium dioxide and zinc oxide. Both ingredients are mineral UV filters that are commonly used in over-the-counter sunscreen products to help block ultraviolet radiation from the sun. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for sunscreen ingredients and labeling rather than undergoing individual product review. The cream form is applied directly to the skin.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
83531-0499-00 You're viewing this Main listing 118 mL in 1 BOTTLE 2023-06-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Coral Safe SPF-30 Broad Spectrum Sunscreen 60 mg/mL; 60 mg/mL 71221-0791-06 Elements 177 ml — — FDA listed —
Coral Safe SPF-30 Broad Spectrum Sunscreen 60 mg/mL; 60 mg/mL 71221-0792-08 Elements 236 ml — — FDA listed —
Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut) 60 mg/mL; 60 mg/mL 71221-0793-08 Elements 236 ml — — FDA listed —
Tropical Sands, SPF-50 Broad Spectrum Sunscreen 60 mg/mL; 60 mg/mL 71221-0794-54 Elements 159 ml — — FDA listed —
Tropical Sands SPF-30 Broad Spectrum Sunscreen 60 mg/mL; 60 mg/mL 71221-0795-06 Elements 177 ml — — FDA listed —
Tropical Sands SPF-30 Broad Spectrum Sunscreen 60 mg/mL; 60 mg/mL 71221-0796-08 Elements 236 ml — — FDA listed —
Pure Haven Body Spf 30 60 mg/mL; 60 mg/mL 71355-0349-00 Pure 90 ml — — FDA listed —
Pure Haven Essentials 60 mg/mL; 60 mg/mL 71355-0819-03 Pure 90 ml — — FDA listed —
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen 60 mg/mL; 60 mg/mL 71889-0350-08 Kapa'ihi, 1 bottle — — FDA listed —
ONCODERM Rx Mineral Sunscreen SPF-30 60 mg/mL; 60 mg/mL 75087-0074-04 Oncoderm, 118 ml — — FDA listed —
KOVR All-Natural SPF-30 Moisturizing Sunscreen for Men 60 mg/mL; 60 mg/mL 83531-0497-00 ACTIVE 118 ml — — FDA listed —
KOVR All-Natural SPF-30 Moisturizing Sunscreen for Women 60 mg/mL; 60 mg/mLthis 83531-0499-00 ACTIVE 118 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Jun 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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 66YXD4DKO9
    A natural oil extracted from almond kernels. It's used in medicines as an emollient and solvent to help dissolve or suspend active ingredients and improve texture in topical and oral formulations.
  • 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 L56Z1JK48B
    A vegetable-derived ingredient used primarily as a natural colorant and flavoring agent in medicines. It provides orange-yellow color and mild taste to tablets, capsules, or liquids.
  • UNII D9108TZ9KG
    Cocoa is a natural powder made from roasted cacao beans. It's used as a flavoring and coloring agent to make medicines taste better and appear brown.
  • UNII 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • 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 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 W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII BKJ0J3D1BP
    A plant-derived ingredient from sunflower flowers, used as a natural colorant and flavoring agent in medicines. It may help provide color or mild taste to the product.
  • 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 QX10HYY4QV
    Sesame oil is a plant-derived oil from sesame seeds. It's used in medicines as a solvent or carrier to dissolve or suspend active ingredients, helping them mix evenly throughout the formulation.
  • UNII Z6GFR7R72Y
    A plant-derived cleaning agent used as a surfactant and emulsifier. It helps mix water and oil-based ingredients together and improves how the medicine spreads or is absorbed.
  • 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 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 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.

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

The official label also statesAloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides  Hydroxypropylsulfonate, Theobroma Cocao (Cocoa) Butter, Tocopherol (Vitamin E), 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.

Manufacturer & labeler

LabelerACTIVE LIFE INC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83531
First marketedJun 2023
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from ACTIVE LIFE INC labeler code 83531

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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 27 words ▾

Uses: Our SPF formulas provide both UVA and UVB protection, and are infused with antioxidants and nutrients to help prevent sun damage while keeping the skin well-hydrated.

⏱️ Dosage and Administration 88 words ▾

Directions: Apply liberally and evenly prior to sun exposure. Reapply after towel drying, or prolonged swimming or sweating. 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 of 15 or higher and other sun protection measures including limiting time in the sun, especially between 10 a.m. - 2 p.m., and wearing long-sleeve shirts, pants, hats and sunglasses. For use on children under 6: consult a physician. Sun Protection Measures:

⚠️ Warnings 66 words ▾

WARNINGS: For external use only. Do not use on damaged or broken skin. When using this product avoid contact with eyes. If contact with eyes occurs, flush with water to remove. Stop using and ask a doctor if irritation or rash develops or persists. Keep out of reach of children. If product is swallowed, seek immediate medical attention or contact a Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active Ingredients Titanium Dioxide 6% Zinc Oxide 6% Purpose Sunscreen

🧪 Inactive Ingredients 59 words ▾

Inactive Ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Theobroma Cocao (Cocoa) Butter, Tocopherol (Vitamin E), Xanthan Gum.

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin.

📄 When Using This Product 18 words ▾

When using this product avoid contact with eyes. If contact with eyes occurs, flush with water to remove.

📄 Stop Use and Ask a Doctor If 13 words ▾

Stop using and ask a doctor if irritation or rash develops or persists.

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children. If product is swallowed, seek immediate medical attention or contact a Poison Control Center right away.

📄 Questions or Comments 6 words ▾

Questions? Visit www.TheActiveLifeCompany.com or call 800-410-6154

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling: Label2

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 KOVR All-Natural SPF-30 Moisturizing Sunscreen for Women (this brand).

Top reported reactions

Application Site Acne1
Application Site Hypersensitivity1
Application Site Vesicles1

Reporter sex

1 reports
Female · 100%

Serious outcomes

Hospitalization1
Reports over time (by year) — tap or hover for the count & year
2025 2026 1 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.

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 ACTIVE LIFE INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ACTIVE LIFE INC 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.
← 83531-0497-00 · ACTIVE 83531-0501-01 · ACTIVE →
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.