Home › NDC Lookup › Ingredients › Zinc Oxide › 58892-0101-50
TIZO PHOTOCEUTICAL AM REPLENISH - TINTED Zinc Oxide 160 mg/g Cream — NDC 58892-0101-50 package photo

TIZO PHOTOCEUTICAL AM REPLENISH - TINTED Zinc Oxide 160 mg/g Cream

by Fallien Cosmeceuticals, LTD · 1 TUBE in 1 CARTON (58892-101-50) / 50 g in 1 TUBE
NDC 58892-0101-50
🏷️ FDA NDC (as labeled) 58892-101-50 billing pads the product segment with a zero
This package
Contains50 g in 1 tube Pack sizes4 compare ↓
Also comes in: 1.5 g 58892-0101-15 5 g 58892-0101-05 30 g 58892-0101-30
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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 Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 58892-101-50
Product NDC 58892-101
11-digit billing NDC 58892010150
UNII SOI2LOH54Z
Application # M020
SPL Set ID fbafa468-fce0-4597-bcb0-a816dc71ec7c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-10-13
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 58892-101-50 — 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 → 58892-0101-50. 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

LabelerFallien Cosmeceuticals, LTD
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code58892
First marketedOct 2015
Product typeHuman Otc Drug
Portfolio37 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?

TiZO Photoceutical AM Replenish is a tinted cream applied to the skin containing zinc oxide. Zinc oxide is a mineral ingredient commonly used in over-the-counter skincare products as a physical sun-protective agent. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for its category rather than undergoing individual product review.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (3 interactions) — ranked by severity →
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 1N032N7MFO
    A brown-colored mineral form of iron oxide used as a colorant in tablets and capsules. It gives medicines their brown or tan appearance without affecting how the drug works.
  • UNII 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • UNII XHK3U310BA
    Cyclohexasiloxane is a silicon-based liquid that acts as a solvent and conditioning agent in medicines. It helps dissolve or carry other ingredients and improves how the product spreads or feels on the skin.
  • UNII H8YMB5QY0D
    A silicone-based oily substance used as a lubricant and anti-foaming agent. It helps the tablet or capsule slide smoothly during manufacturing and prevents excess foam in liquid formulations.
  • UNII UF7620L1W6
    A synthetic silicone polymer that acts as a thickener and absorbent in medicines. It helps create the right texture, improves how the product feels on skin or in the mouth, and can absorb excess moisture or oil in formulations.
  • 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 T74O12AN6Y
    A silicone oil that reduces foam and prevents clumping. It's used as an anti-foaming agent and lubricant in tablets and capsules to improve how the medicine flows during manufacturing.
  • UNII 12Z59IF64N
    Hydrogen dimethicone is a silicone-based fluid that acts as a lubricant and anti-foaming agent in medicines. It helps the product flow smoothly during manufacturing and prevents excess air bubbles from forming.
  • 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 8PR7V1SVM0
    A silicone-based lubricant combined with polyethylene glycol. It reduces friction and helps the medicine flow smoothly during manufacturing and improves how the product feels when applied or swallowed.
  • 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 9LBV3F07AZ
    A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during storage.
  • UNII 9NH1UDD2RR
    A synthetic silicone polymer that forms a smooth, water-resistant film. Used in topical formulations as a skin protectant coating and to improve product texture and spreadability on the skin.

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

The official label also statesCapric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Hydrogen Dimethicone Silsesquioxane Crosspolymer

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.
Try another pack size: 1.5 g 5 g 30 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Skin Apeel Ageless Defense SPF 40 Broad Spectrum 160 mg/g 83628-0208-50 Skin 50 g — — FDA listed —
Illuminating Daily SPF 40 Lightly Tinted 160 mg/g 85302-0208-50 Face 50 g — — FDA listed —
Matte Invisible Mineral Sunscreen 160 mg/g 85306-0208-50 INTEGRATIVE 50 g — — FDA listed —
Matte Invisible Mineral Sunscreen Non-Tinted 160 mg/g 85306-0226-50 INTEGRATIVE 50 g — — FDA listed —
Replenishing Mineral Sunscreen 160 mg/g 85330-0208-50 Skin 50 g — — FDA listed —
Florida Babe Everyday Tinted Replenishing Daily Protection 160 mg/g 85337-0208-15 Tichy 1.5 g — — FDA listed —
Daily Replenish mineral sunscreen 160 mg/g 85367-0208-50 PURE 50 g — — FDA listed —
Nourish Non-Tinted Mineral Sunscreen 160 mg/g 85387-0226-50 Fern 50 g — — FDA listed —
Daily Protection 40 160 mg/g 85392-0208-50 2301 50 g — — FDA listed —
Canopy SPF 40 Tinted 160 mg/g 85399-0208-50 BORREGO 50 g — — FDA listed —
Bio H Plus Daily Defense And Revitalize 160 mg/g 85403-0208-15 BIOHEALTH 1.5 g — — FDA listed —
SPF 101 Non-Tinted 160 mg/g 85415-0226-50 The 50 g — — FDA listed —
Tinted Replenishing Daily Protection 160 mg/g 85513-0208-50 THE 50 g — — FDA listed —
Daily Restore 160 mg/g 85556-0208-15 TYRLIN 1.5 g — — FDA listed —
Sacred Glow 160 mg/g 85583-0208-50 IRIA 50 g — — FDA listed —
Skin Shield Plus 160 mg/g 85596-0208-50 LAURA 50 g — — FDA listed —
Hydra Tint 160 mg/g 85649-0208-50 PATRICIA 50 g — — FDA listed —
Auset Tinted Replenishing Daily Protection 160 mg/g 85725-0208-50 SHAYLA 50 g — — FDA listed —
Daily Repair Moisturizing Non Tinted 160 mg/g 85738-0226-15 Skintique 1.5 g — — FDA listed —
Tinted Mineral Sunscreen 160 mg/g 85747-0208-50 WECARE 50 g — — FDA listed —
Radiance 160 mg/g 85768-0226-15 L.S. 1.5 g — — FDA listed —
Replenishing Daily Protection Tinted 160 mg/g 87149-0208-15 SOLUTIONS 1.5 g — — FDA listed —
Replenishing Daily Protection Non-Tinted 160 mg/g 87149-0226-50 SOLUTIONS 50 g — — FDA listed —
Easy Everything Sunscreen 160 mg/g 87670-0208-50 VLT 50 g — — FDA listed —
Emme Diane Pure Protection Tinted Antioxidant Sunscreen 160 mg/g 81377-0208-50 Emme 50 g — — FDA listed —
Parasol Daily Mineral Sunscreen Non-Tinted 160 mg/g 85373-0226-50 Bodi 50 g — — FDA listed —
Replenishing Tinted Sunscreen 160 mg/g 85418-0208-50 Beauty 50 g — — FDA listed —
Everyday Mineral Tinted Sunscreen 160 mg/g 85441-0208-50 Atlanta 50 g — — FDA listed —
Daily Mineral Protection 160 mg/g 85452-0226-15 Charisma 1.5 g — — FDA listed —
Serum Lightly Tinted 160 mg/g 85459-0208-15 PANDA 1.5 g — — FDA listed —
Daily Skin Protection Sunscreen Tinted 160 mg/g 85479-0208-50 SKINPLUSBYOROYO 50 g — — FDA listed —
Tinted Mineral Defense SPF 40 160 mg/g 85591-0208-50 JOSEPHINA 50 g — — FDA listed —
Daily Shade Dewy Glow Tinted 160 mg/g 85712-0208-15 BLISS 1.5 g — — FDA listed —
Morning Replenish 160 mg/g 85714-0208-50 KATHY 50 g — — FDA listed —
Daily Repair Moisturizing Tinted 160 mg/g 85738-0208-50 Skintique 50 g — — FDA listed —
Daily Tinted Antioxidant Mineral Sunscreen 160 mg/g 85936-0208-50 MONIKA 50 g — — FDA listed —
AM Shield plus 160 mg/g 87271-0226-50 Grace 50 g — — FDA listed —
Tizo Photoceutical Am Replenish - Tinted 160 mg/gthis 58892-0101-50 Fallien 1 tube — — FDA listed —
Proceuticals Private Label by TiZO non-tinted replenishing daily protection 160 mg/g 58892-0226-50 Fallien 50 g — — FDA listed —
Matte Shield Spf 160 mg/g 85291-0208-50 ACNE 50 g — — FDA listed —
Sunscreen Plus Untinted 160 mg/g 85329-0226-15 Lily 1.5 g — — FDA listed —
Tinted Sunscreen 160 mg/g 85331-0208-50 Scottsdale 53 g — — FDA listed —
Tinted Replenishing Daily Protection 160 mg/g 85377-0208-15 MANTRA 1.5 g — — FDA listed —
Tinted Mineral Sunscreen Plus Primer CPlusE Glow 160 mg/g 85400-0208-50 Simply 50 g — — FDA listed —
Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tinted 160 mg/g 85404-0208-50 NY 50 g — — FDA listed —
SPF 101 Lightly Tinted 160 mg/g 85415-0208-50 The 50 g — — FDA listed —
Mineral Sunscreen Moisturizing Non-Tinted 160 mg/g 85431-0226-50 Cutis 50 g — — FDA listed —
Fair Skin Anti-Aging 160 mg/g 85466-0208-50 DERMOPERFECTION 53 g — — FDA listed —
Non-Tinted Replenishing Daily Protection 160 mg/g 85513-0226-50 THE 50 g — — FDA listed —
Mint Condition 160 mg/g 85533-0208-15 Mint 1.5 g — — FDA listed —
flawless photo finish 160 mg/g 85575-0208-50 NEXTEX 50 g — — FDA listed —
Tinted Restorative Moisturizer 160 mg/g 85582-0208-50 SKINERGIX 50 g — — FDA listed —
Face Love 160 mg/g 85629-0208-50 CLARITY 50 g — — FDA listed —
Magic Veil 160 mg/g 85861-0208-15 THE 1.5 g — — FDA listed —
Non-Tinted Daily Mineral Shield 160 mg/g 85896-0226-50 SIGNATURE 50 g — — FDA listed —
Protect and Renew 160 mg/g 85971-0208-50 ENSO 50 g — — FDA listed —
Shield And Protect 160 mg/g 69487-0226-50 TRILOGY 50 g — — FDA listed —
Parasol Daily Mineral Sunscreen 160 mg/g 85373-0208-50 Bodi 50 g — — FDA listed —
Anti Aging Daily Protection 160 mg/g 85450-0208-50 LEVERRIER, 50 g — — FDA listed —
Replenish SPF 40 160 mg/g 85555-0208-50 ELIZA 50 g — — FDA listed —
Protection E And C Lightly Tinted 160 mg/g 85563-0208-50 CLEAR 50 g — — FDA listed —
D Fend Daily 160 mg/g 85599-0226-50 CLEAN 50 g — — FDA listed —
Tinted Daily Protection Sunscreen 160 mg/g 85711-0208-50 Kemmi 50 g — — FDA listed —
Everyday Mineral Sunscreen 160 mg/g 85889-0208-15 MYRENE 1.5 g — — FDA listed —
Solar Shield Primer SPF 40 160 mg/g 85944-0208-15 BRIGHT 1.5 g — — FDA listed —
Mineral Sunscreen 160 mg/g 87121-0208-50 ISIS 50 g — — FDA listed —
TiZO Photoceutical AM Replenish Non-Tinted 160 mg/g 58892-0107-50 Fallien 1 tube — — FDA listed —
Shield And Protect Tinted 160 mg/g 69487-0208-50 TRILOGY 50 g — — FDA listed —
Lightly Tinted Mineral Block Sunscreen 160 mg/g 85301-0208-15 Tucson 1.5 g — — FDA listed —
Sunscreen Plus Tinted 160 mg/g 85329-0208-15 Lily 1.5 g — — FDA listed —
Healthy Mineral Sunscreen No Shine plus Tint 160 mg/g 85338-0208-50 Zen 50 g — — FDA listed —
Replenishing Daily Protection 160 mg/g 85394-0208-50 The 50 g — — FDA listed —
Shield Mineral Sunscreen Non Tinted 160 mg/g 85417-0226-50 SMOOTHE 50 g — — FDA listed —
208 160 mg/g 85443-0208-50 PETER 53 g — — FDA listed —
Superscreen Daytime Mineral Sunscreen 160 mg/g 85449-0208-50 MCRAE 50 g — — FDA listed —
Restore And Replenish 160 mg/g 85730-0208-50 BELLAGENA 50 g — — FDA listed —
Recoverie Mineral Matte 160 mg/g 85299-0226-50 Clear 50 g — — FDA listed —
Dermablue Daily Replenishing 160 mg/g 85300-0208-50 Dermablue, 50 g — — FDA listed —
Replenish 160 mg/g 85318-0208-50 Maloney 50 g — — FDA listed —
Satin Tint 160 mg/g 85334-0208-15 Brent 1.5 g — — FDA listed —
bare skin smooth mineral tint 160 mg/g 85425-0208-50 Skin 50 g — — FDA listed —
Mineral Sunscreen Moisturizing Lightly Tinted 160 mg/g 85431-0208-50 Cutis 50 g — — FDA listed —
Protector Solar Tinted Spf Sunscreen 160 mg/g 85438-0208-50 The 50 g — — FDA listed —
Glow 160 mg/g 85457-0208-50 GODDESSLYNNEBODYANDSKIN 50 g — — FDA listed —
Tinted Replenishing SPF40 160 mg/g 85508-0208-50 RSL89 50 g — — FDA listed —
Tinted Replenishing Daily Protection 160 mg/g 85611-0208-15 SKINPLICITY 1.5 g — — FDA listed —
Non Tinted Replenishing Daily Protection 160 mg/g 85625-0226-50 LUNDQUIST 50 g — — FDA listed —
Non-Tinted Mineral Sunscreen 160 mg/g 85747-0226-15 WECARE 1.5 g — — FDA listed —
Antioxidant SPF 160 mg/g 85339-0208-50 Teton 50 g — — FDA listed —
Sunshield Moisturizing Sunscreen and Antioxidant 160 mg/g 85340-0208-15 Oculofacial 1.5 g — — FDA listed —
Skin Defense Matte Tinted Sunscreen 160 mg/g 85366-0208-50 Gentlehomme 50 g — — FDA listed —
Tinted Replenishing Daily Protection 160 mg/g 85467-0208-50 Tory 50 g — — FDA listed —
Daydream Beyond Screen 160 mg/g 85491-0208-50 ULTRAVIOLET 50 g — — FDA listed —
Ultra Silk Protection Sunscreen 160 mg/g 85564-0208-50 SKINFINITY 50 g — — FDA listed —
Tinted Replenishing Daily Protection 160 mg/g 85589-0208-50 Natur 50 g — — FDA listed —
Hydrating Antioxidant Sunscreen tinted 160 mg/g 85641-0208-15 KRISTI 1.5 g — — FDA listed —
CoTZ Face Moisture 160 mg/g 58892-0360-42 Fallien 1 tube — — FDA listed —
Replenishing Daily Protection Sunscreen Invisible 160 mg/g 81679-0208-50 KATHLEEN 50 g — — FDA listed —
Advanced Light Perfecting Sunscreen 160 mg/g 85351-0208-15 ADVANCED 1.5 g — — FDA listed —
Mineral Tinted SPF40 with ceramides 160 mg/g 85360-0208-50 Spalina 50 g — — FDA listed —
Tinted Daily Replenishing Protection 160 mg/g 85362-0208-50 Goldberg, 50 g — — FDA listed —
Am Restore 160 mg/g 85364-0208-15 Minder 1.5 g — — FDA listed —
Shield Mineral Sunscreen Tinted 160 mg/g 85417-0208-50 SMOOTHE 50 g — — FDA listed —
Age Defying Sunscreen 160 mg/g 85458-0226-50 GINAMARIE 50 g — — FDA listed —
Antioxidant Mineral Sunscreen Plus Primer Lightly Tinted 160 mg/g 85520-0208-50 True 50 g — — FDA listed —
GLOW UP Ageless Daily Protection Sunscreen 160 mg/g 85752-0208-15 CLEAN 15 g — — FDA listed —
Solar Shield Tinted 160 mg/g 85890-0208-15 DENISE 1.5 g — — FDA listed —
Anti-Aging Tinted Sunscreen 160 mg/g 85921-0208-50 KARINA 50 g — — FDA listed —
Morning Replenish 160 mg/g 85313-0208-50 Restore 50 g — — FDA listed —
Replenishing Daily Sunscreen 160 mg/g 85374-0208-50 BABYFACE 50 g — — FDA listed —
Replenishing Daily Protection Tinted 160 mg/g 85451-0208-50 MY 53 g — — FDA listed —
Tinted Replenishing Daily Protection 160 mg/g 85679-0208-50 HELTON 50 g — — FDA listed —
Tinted BB Cream 160 mg/g 85863-0208-50 Eco 50 g — — FDA listed —
Non-Tinted Replenishing Daily Protection 160 mg/g 87122-0226-50 MADRE 50 g — — FDA listed —
Proceuticals Private Label by TiZO tinted replenishing daily protection 160 mg/g 58892-0208-50 Fallien 50 g — — FDA listed —
Illuminating Daily SPF40 Non-Tinted 160 mg/g 85302-0226-50 Face 50 g — — FDA listed —
Replenishing Daily Protection NT 160 mg/g 85451-0226-50 MY 53 g — — FDA listed —
Restore Tinted Moisturizing 160 mg/g 85503-0208-50 SKIN 50 g — — FDA listed —
Tinted Replenishing Daily Protection 160 mg/g 85805-0208-50 OLGA 50 g — — FDA listed —
Tinted Daily Mineral Shield 160 mg/g 85896-0208-50 SIGNATURE 50 g — — FDA listed —
Replenishing Daily Protection Tinted 160 mg/g 87003-0208-50 YUMA 50 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

🏛️
2015
On the market since
Oct 2015
📍
2026
Currently FDA-listed
11 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 TIZO PHOTOCEUTICAL AM REPLENISH - TINTED (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Reporter sex

0 reports

Serious outcomes

Death204
Life-threatening116
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 229 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
58892-0101-50 You're viewing this 1 TUBE in 1 CARTON (58892-101-50) / 50 g in 1 TUBE 2019-07-23 Active
58892-0101-15 1.5 g in 1 PACKET (58892-101-15) 2019-07-23 Active
58892-0101-05 5 g in 1 TUBE (58892-101-05) 2019-07-23 Active
58892-0101-30 30 g in 1 TUBE (58892-101-30) 2015-10-13 Active

Pack size FAQ

What quantity is in NDC 58892-0101-50?
NDC 58892-0101-50 is listed by the FDA — 1 tube in 1 carton / 50 g in 1 tube.
What NDC number is used to bill for this package of TIZO PHOTOCEUTICAL AM REPLENISH - TINTED Zinc Oxide 160 mg/g Cream?
Bill NDC 58892-0101-50 — the 11-digit billing format is 58892010150. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 58892-101-50, 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: 58892-0101-50, written without dashes as 58892010150. 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 58892-0101-50, the first segment (58892) is the labeler code FDA assigned to Fallien Cosmeceuticals, LTD; the middle segment (0101) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 Fallien Cosmeceuticals, LTD. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1.5 g (58892-0101-15), 5 g (58892-0101-05), 30 g (58892-0101-30). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Fallien Cosmeceuticals, 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 30 words ▾

Uses: Helps prevents 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 91 words ▾

Directions: Apply liberally 15 minutes before sun exposure. Use a water resistant product if swimming or sweating. Reapply: At least every 2 hours 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

⚠️ Warnings 54 words ▾

Warnings: For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredients: Zinc Oxide 16%

🧪 Inactive Ingredients 32 words ▾

Inactive Ingredients: Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Hydrogen Dimethicone Silsesquioxane Crosspolymer

🎯 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 ↗
← 58892-0072-04 · Fallien 58892-0105-30 · Fallien →
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.