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Organys Derma Made Sheer Zinc Oxide 132 mg/mL Lotion, 45 mL — NDC 83612-1039-01 package photo

Organys Derma Made Sheer Zinc Oxide 132 mg/mL Lotion, 45 mL

by Organys Beauty · 45 mL in 1 BOTTLE, PUMP (83612-1039-1)
NDC 83612-1039-01
🏷️ FDA NDC (as labeled) 83612-1039-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ 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 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) 83612-1039-1
Product NDC 83612-1039
11-digit billing NDC 83612103901
UNII SOI2LOH54Z
Application # M020
SPL Set ID 0b39f550-bd34-509d-e063-6294a90a51d0
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-08-04
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 83612-1039-1 — a 5-4-1 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 package segment → 83612-1039-01. 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

LabelerOrganys Beauty
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83612
First marketedAug 2021
Product typeHuman Otc Drug
Portfolio5 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?

Organys Derma Made Sheer Zinc Oxide is a topical lotion containing zinc oxide, a mineral ingredient commonly used in over-the-counter skincare and sun protection products. Zinc oxide functions as a broad-spectrum physical sunscreen agent and is also typically included in formulations meant to soothe and protect the skin. This product is marketed as an OTC monograph drug, meaning it follows FDA's established safety and use guidelines for this category rather than undergoing individual product approval.

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.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 105S6I733Z
    A natural oil extracted from chamomile and other plants. It acts as a fragrance and flavoring agent to improve the taste and smell of the medicine.
  • UNII 2EH13UN8D3
    A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII I835H2IHHX
    A waxy substance derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water ingredients together and keep them blended throughout the product's shelf life.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 7E6SK9QDT8
    Cyclodextrins are ring-shaped sugar molecules derived from starch. They're used in medicines as solubilizers to help poorly dissolving drugs dissolve better, and sometimes as binders or stabilizers.
  • 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 KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • UNII UDR641JW8W
    A plant-derived oil from jojoba seeds that has been broken down into smaller components. It acts as an emollient and skin-conditioning agent to help soften and smooth the product's texture.
  • UNII M1SLX00M3M
    Isoamyl laurate is a synthetic ester made from isoamyl alcohol and lauric acid. It functions as an emollient and lubricant in topical formulations to help smooth and soften the skin.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII N8F53B3R4R
    A synthetic humectant and solvent derived from propane. It draws and holds moisture in the formulation, helping keep the medicine stable and improving texture or flow in liquid and semi-solid products.
  • UNII 0F897O3O4M
    A naturally occurring alcohol derived from plants or synthesized chemically. It functions as a preservative and flavoring agent in medicines, helping prevent microbial growth and add pleasant taste to oral products.
  • UNII 9229XJ4V12
    A synthetic emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients in formulations, keeping them mixed and preventing separation.
  • UNII 8ZQ0AYU1TT
    Pullulan is a natural polysaccharide, a type of carbohydrate made from yeast. It acts as a binder and film-former to hold tablet ingredients together and create protective coatings on capsules.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 L0Q8IK9E08
    A synthetic compound made from stearic acid and polyethylene glycol. It acts as an emulsifier and solubilizer, helping mix oil and water-based ingredients and keeping them blended throughout the medicine's shelf life.
  • 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.

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

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
Indie Lee Daily Primer 132 mg/mL 78870-0245-02 America 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St12.5 Ramla Bay) 132 mg/mL 81110-0054-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St4 Formosa) 132 mg/mL 81110-0753-02 Ilia, 1 bottle — — FDA listed —
Golden Ray Sunscreen (Deep Tinted) 132 mg/mL 82184-1350-02 A-Frame 1 bottle — — Discontinued —
Daybird Tinted Skincare (SHADE 2) 132 mg/mL 82417-1063-02 Resette, 1 bottle — — FDA listed —
Ciele Bronze and Protect 132 mg/mL 83103-2255-02 Ciele 1 bottle — — FDA listed —
DRMTLGY Lip Silk - Bold 132 mg/mL 83286-0140-02 DRMTLGY 1 bottle — — FDA listed —
Alleyoop Sun Serum Lip Oil 132 mg/mL 84830-2107-02 NewAlley 1 bottle — — Discontinued —
Sunsolve MD Volumize and Condition Lip 132 mg/mL 84878-0107-02 Sunsolve 1 bottle — — FDA listed —
Sunsolve MD Mineral Shade Bronzite 004 132 mg/mL 84878-0404-02 Sunsolve 1 bottle — — FDA listed —
Sunsolve MD Mineral Shade Garnet 005 132 mg/mL 84878-0405-02 Sunsolve 1 bottle — — FDA listed —
Daily Essential Lip Oil Scarlet Bloom 132 mg/mL 84891-1842-01 Solarium 10 ml — — FDA listed —
Yon-Ka 50 Mineral Fluid 132 mg/mL 51191-2667-02 Laboratoire 1 tube — — FDA listed —
PUR 4-in-1 Skin Tint LG3 132 mg/mL 67345-0051-00 PUR 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St7 Diaz) 132 mg/mL 81110-0755-02 Ilia, 1 bottle — — FDA listed —
Bloomeffects Tulip Dew 132 mg/mL 82548-2193-04 Bloomeffects 1 bottle — — FDA listed —
Bloomeffects Tulip Dew Bronze 132 mg/mL 82548-2768-02 Bloomeffects 1 bottle — — FDA listed —
Melan RX 132 mg/mL 82635-0403-01 Melan 45 ml — — FDA listed —
Inde Wild 132 mg/mL 83054-1502-02 Inde 1 bottle — — FDA listed —
DRMTLGY Lip Silk - Soft 132 mg/mL 83286-0139-02 DRMTLGY 1 bottle — — FDA listed —
Blume Sunburst Sunscreen 132 mg/mL 83656-2106-02 Blume 1 bottle — — FDA listed —
Daily Essential Lip Oil Blushing Nude 132 mg/mL 84891-2107-01 Solarium 10 ml — — FDA listed —
Skin Metal Stealth 132 mg/mL 87098-0236-02 Skin 1 bottle — — FDA listed —
Knesko Skin The Sunscreen 132 mg/mL 87407-0236-02 Knesko, 1 bottle — — FDA listed —
PUR 4-in-1 Skin Tint DG6 132 mg/mL 67345-0057-00 PUR 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St9.5 Baikal) 132 mg/mL 81110-0052-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St17.5 Perissa) 132 mg/mL 81110-0059-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St19 Lovina) 132 mg/mL 81110-0060-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St6 Ora) 132 mg/mL 81110-0691-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St1 Rendezvous) 132 mg/mL 81110-0750-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St9 Paloma) 132 mg/mL 81110-0757-02 Ilia, 1 bottle — — FDA listed —
Golden Rays Sunscreen (Light Tinted) 132 mg/mL 82184-1351-02 A-Frame 1 bottle — — Discontinued —
Daybird Tinted Skincare (SHADE 1) 132 mg/mL 82417-1062-02 Resette, 1 bottle — — FDA listed —
Hanalei Face Moisturizing 132 mg/mL 82915-2133-02 Hanalei 1 tube — — FDA listed —
Balmere Mineral Sunscreen Moisturizer Primer 132 mg/mL 83241-1039-02 Balmere 1 bottle — — FDA listed —
Iris and Romeo Weekend Skin 132 mg/mL 83247-1321-02 Iris 1 tube — — FDA listed —
Iris and Romeo Weekend Skin Warm Glow 132 mg/mL 83247-1838-02 Iris 1 tube — — FDA listed —
Alleyoop Sun Serum Lip Oil - Daylight 132 mg/mL 84830-7210-02 NewAlley 1 bottle — — FDA listed —
Sunsolve MD Correct and Fade 132 mg/mL 84878-0200-02 Sunsolve 1 bottle — — FDA listed —
Solarium Daily Essentials Luminizing Glow Drops 132 mg/mL 84891-2191-01 Solarium 30 ml — — FDA listed —
Oiana Mineral Sunscreen Drops 132 mg/mL 87342-2368-02 Oiana 1 bottle — — FDA listed —
PUR 4-in-1 Skin Tint TN7 132 mg/mL 67345-0055-00 PUR 1 bottle — — FDA listed —
Riversol Daily Glow Mineral Tinted 132 mg/mL 72019-2035-02 Riversol 1 bottle — — FDA listed —
Volition Prismatic Luminizing Shield 132 mg/mL 72577-0624-02 Volition 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St10 Porto Ferro) 132 mg/mL 81110-0758-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St12 Kokkini) 132 mg/mL 81110-0760-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St16 Pavones) 132 mg/mL 81110-0764-02 Ilia, 1 bottle — — FDA listed —
KINLO Golden Rays Sunscreen 132 mg/mL 82184-4480-02 A-Frame 1 bottle — — Discontinued —
Daybird Tinted Skincare (SHADE 3) 132 mg/mL 82417-1064-02 Resette, 1 bottle — — FDA listed —
Ciele Tint and Protect 132 mg/mL 83103-1819-02 Ciele 1 bottle — — FDA listed —
Duette Tinted 132 mg/mL 84123-2034-02 Skin 1 bottle — — FDA listed —
Daily Essential Face Moisturizer 132 mg/mL 84891-2185-01 Solarium 60 ml — — FDA listed —
Sonni SunDay Serum 132 mg/mL 85260-0282-02 Sonni 1 bottle — — FDA listed —
Peachy Tinted Facial Sunscreen 132 mg/mL 85600-2034-02 Peachy 1 bottle — — FDA listed —
Peachy Mineral Facial Sunscreen 132 mg/mL 85600-2368-02 Peachy 1 bottle — — FDA listed —
Odacite Nourishing Lip Serum - Bubble Gum 132 mg/mL 82088-0871-02 Odacite 1 bottle — — FDA listed —
SOL Science The Fifty 132 mg/mL 83282-0139-02 Beauty 1 bottle — — FDA listed —
DRMTLGY Lip Silk 132 mg/mL 83286-0213-02 DRMTLGY 1 bottle — — Discontinued —
Riversol Tinted Lip Oil - Poppy 132 mg/mL 63931-8421-02 Solesence, 1 tube — — FDA listed —
PUR 4-in-1 Skin Tint DP3 132 mg/mL 67345-0056-00 PUR 1 bottle — — FDA listed —
Naked Sundays BeautyScreen Peptide Foundation Tint 132 mg/mL 81104-0664-02 Naked 1 tube — — FDA listed —
Ilia Super Serum Skin Tint (St0.5 Skye) 132 mg/mL 81110-0049-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St2.5 Sombrio) 132 mg/mL 81110-0050-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St11 Matira) 132 mg/mL 81110-0759-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St13 Kamari) 132 mg/mL 81110-0761-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St15 Porto Covo) 132 mg/mL 81110-0763-02 Ilia, 1 bottle — — FDA listed —
Bloomeffects Tulipscreen Hydrating Lip Oil Tulipy Pink 132 mg/mL 82548-2340-02 Bloomeffects 1 bottle — — FDA listed —
Covey Sun and Done Daily Moisturizing 132 mg/mL 83338-0087-02 Covey 1 tube — — FDA listed —
Vaihea Protect Clean SPF Drops 132 mg/mL 83395-0050-02 Vaihea 1 bottle — — FDA listed —
Organys Derma Made 132 mg/mL 83612-0330-01 Organys 45 ml — — Discontinued —
Organys Open Formula Sheer 132 mg/mL 83612-1391-01 Organys 45 ml — — FDA listed —
Green Envee Radiance Sheer 132 mg/mL 83678-2726-02 Green 1 bottle — — FDA listed —
Alleyoop Sunsational Broad Spectrum 132 mg/mL 84830-2431-02 NewAlley 1 tube — — Discontinued —
Sunsolve MD Firm and Replenish 132 mg/mL 84878-0199-02 Sunsolve 1 bottle — — FDA listed —
Sunsolve MD Calm and Revitalize 132 mg/mL 84878-0654-02 Sunsolve 1 bottle — — FDA listed —
Riversol Daily Glow Mineral Untinted 132 mg/mL 72019-2033-02 Riversol 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St6.5 Kai) 132 mg/mL 81110-0051-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St12.75 Papakolea) 132 mg/mL 81110-0055-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St13.5 Rialto) 132 mg/mL 81110-0056-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St16.5 Jardin) 132 mg/mL 81110-0058-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St5 Bom Bom) 132 mg/mL 81110-0754-02 Ilia, 1 bottle — — FDA listed —
Odacite Nourishing Lip Serum - True Nude 132 mg/mL 82088-0875-02 Odacite 1 bottle — — FDA listed —
Live Tinted Hueguard Skin Tint 132 mg/mL 82153-0192-02 Live 1 tube — — FDA listed —
Bloomeffects Tulipscreen Hydrating Lip Oil 132 mg/mL 82548-2341-02 Bloomeffects 1 bottle — — Discontinued —
Organys Derma Made Sheer 132 mg/mLthis 83612-1039-01 Organys 45 ml — — FDA listed —
Sunsolve MD Mineral Shade Quartz 001 132 mg/mL 84878-0401-02 Sunsolve 1 bottle — — FDA listed —
PUR 4-in-1 Skin Tint MN3 132 mg/mL 67345-0052-00 PUR 1 bottle — — FDA listed —
Odacite Flex Perfecting Mineral Drops Tinted Sunscreen 132 mg/mL 82088-0214-02 Odacite 1 bottle — — FDA listed —
Daybird Tinted Skincare (SHADE 4) 132 mg/mL 82417-1065-02 Resette, 1 bottle — — FDA listed —
Organys Derma Made 132 mg/mL 83612-0282-01 Organys 45 ml — — Discontinued —
Agent Natuer holi (sun) dewy tinted skin drops 132 mg/mL 83633-2063-02 Agent 1 bottle — — FDA listed —
Guise Tinted Drops 132 mg/mL 83827-1208-02 Donis 1 bottle — — FDA listed —
Duette Untinted 132 mg/mL 84123-2033-02 Skin 1 bottle — — FDA listed —
Depology Essential Mineral UV Care 132 mg/mL 84133-1039-02 Depology 1 tube — — FDA listed —
Morning Person Daily Repair Protect Moisturizer 132 mg/mL 84846-1039-02 Morning 1 tube — — FDA listed —
Sunsolve MD Mineral Shade Amber 002 132 mg/mL 84878-0402-02 Sunsolve 1 bottle — — FDA listed —
Daily Essential Lip Oil Dusty Rose 132 mg/mL 84891-2181-01 Solarium 10 ml — — FDA listed —
Riversol Tinted Lip Oil - Poppy 132 mg/mL 72019-1842-02 Riversol 1 tube — — FDA listed —
Ilia Super Serum Skin Tint (St11.5 Morgat) 132 mg/mL 81110-0053-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St14.5 Honopu) 132 mg/mL 81110-0057-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St3 Balos) 132 mg/mL 81110-0752-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St8 Shela) 132 mg/mL 81110-0756-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St14 Dominica) 132 mg/mL 81110-0762-02 Ilia, 1 bottle — — FDA listed —
Odacite Nourishing Lip Serum - Jazzy Berry 132 mg/mL 82088-0876-02 Odacite 1 bottle — — FDA listed —
Daybird 4-in-1 Skin Tint Serum 132 mg/mL 82417-1210-02 Resette, 1 bottle — — FDA listed —
Green Envee Sun Shield Serum 132 mg/mL 83678-2049-02 Green 1 bottle — — Discontinued —
Sunsolve MD Mineral Shade Agate 003 132 mg/mL 84878-0403-02 Sunsolve 1 bottle — — FDA listed —
PUR 4-in-1 Skin Tint MN4 132 mg/mL 67345-0053-00 PUR 1 bottle — — FDA listed —
PUR 4-in-1 Skin Tint TN2 132 mg/mL 67345-0054-00 PUR 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St2 Tulum) 132 mg/mL 81110-0751-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St17 Miho) 132 mg/mL 81110-0765-02 Ilia, 1 bottle — — FDA listed —
Ilia Super Serum Skin Tint (St18 Mali) 132 mg/mL 81110-0766-02 Ilia, 1 bottle — — FDA listed —
DMK Ultrascreen Mineral Sunscreen 132 mg/mL 81537-0282-02 Danne 1 bottle — — FDA listed —
Odacite Mineral Drops Sheer Sunscreen 132 mg/mL 82088-0285-02 Odacite 1 bottle — — FDA listed —
KINLO Golden Rays Sunscreen (Medium Tinted) 132 mg/mL 82184-1173-02 A-Frame 1 bottle — — Discontinued —
Bloomeffects Tulipscreen Hydrating Lip Oil Barely 132 mg/mL 82548-1234-02 Bloomeffects 1 bottle — — FDA listed —
Bloomeffects Tulipscreen Hydrating Lip Oil Fruit Punch 132 mg/mL 82548-2350-02 Bloomeffects 1 bottle — — FDA listed —
Bloomeffects Tulipscreen Hydrating Lip Oil Mauve Moment 132 mg/mL 82548-2601-02 Bloomeffects 1 bottle — — FDA listed —
Aspen Islanders Sheer Mineral Sport 132 mg/mL 83382-1005-02 Aspen 1 tube — — FDA listed —
Organys Derma Made 132 mg/mL 83612-0403-01 Organys 45 ml — — FDA listed —
Sunsolve MD Mineral Shade Onyx 006 132 mg/mL 84878-0406-02 Sunsolve 1 bottle — — FDA listed —
Sunsolve MD Balance and Clear 132 mg/mL 84878-0997-02 Sunsolve 1 bottle — — FDA listed —
Sunsolve MD Detox and Shield 132 mg/mL 84878-0998-02 Sunsolve 1 bottle — — FDA listed —
Skin Metal Green Stealth 132 mg/mL 87098-0270-02 Skin 1 bottle — — FDA listed —
BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis) 132 mg/mL 51386-0291-02 Napoleon 1 tube — — FDA listed —
PUR 4-in-1 Skin Tint LN2 132 mg/mL 67345-0050-00 PUR 1 bottle — — FDA listed —
Omnilux Mineral Facial Sunscreen 132 mg/mL 83866-1762-02 The 1 bottle — — 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
Aug 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.

🔬 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 Organys Derma Made Sheer (this brand).

Top reported reactions

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

Reporter sex

0 reports
Male · 37%
Female · 63%
Unknown · 0%

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
83612-1039-01 You're viewing this 45 mL in 1 BOTTLE, PUMP (83612-1039-1) 2021-08-04 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 83612-1039-1, 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: 83612-1039-01, written without dashes as 83612103901. 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 83612-1039-01, the first segment (83612) is the labeler code FDA assigned to Organys Beauty; the middle segment (1039) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Organys Beauty. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Organys Beauty 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 7 words ▾

Organys Derma Made Sheer Indication and Usage

⏱️ Dosage and Administration 7 words ▾

Organys Derma Made Sheer Dosage and Administration

⚠️ Warnings 6 words ▾

Organys Derma Made Sheer Warning Label

🧪 Active Ingredient 6 words ▾

Organys Derma Made Sheer Active Ingredients

🧪 Inactive Ingredients 6 words ▾

Organys Derma Made Sheer Inactive ingredients

🎯 Purpose 5 words ▾

Organys Derma Made Sheer purpose

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 83612-0403-01 · Organys 83612-1391-01 · Organys →
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.