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ACTIVE ARGAN 365 SPF 30 BROAD SPECTRUM ACTIVATED ARGAN COMPLEX ZINC OXIDE 220 mg/mL Oil — NDC 70803-0250-01 package photo

ACTIVE ARGAN 365 SPF 30 BROAD SPECTRUM ACTIVATED ARGAN COMPLEX ZINC OXIDE 220 mg/mL Oil

by SIBORG LLC · 1 BOTTLE in 1 BOX (70803-250-01) / 50 mL in 1 BOTTLE
NDC 70803-0250-01
🏷️ FDA NDC (as labeled) 70803-250-01 billing pads the product 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) 70803-250-01
Product NDC 70803-250
11-digit billing NDC 70803025001
UNII SOI2LOH54Z
Application # M020
SPL Set ID 9c4897f8-8fcb-4a0f-b42e-f582e2934f02
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 2019-05-01
Route TOPICAL
Dosage form OIL
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 70803-250-01 — 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 → 70803-0250-01. 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

LabelerSIBORG LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code70803
First marketedMay 2019
Product typeHuman Otc Drug
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?

This is an oil-based topical sunscreen marketed under the FDA's over-the-counter monograph rules. It contains zinc oxide, a mineral UV filter commonly used in sunscreens to help protect skin from ultraviolet radiation. The product is formulated with an activated argan complex and provides broad spectrum sun protection with an SPF of 30. It is applied directly to the skin as an oil.

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 A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII 4V59G5UW9X
    Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • UNII EXY4496LWD
    A plant-derived ingredient from the pods of the Caesalpinia spinosa tree, native to South America. It's used as a natural thickener, binder, and source of fiber in formulations.
  • UNII 4828G836N6
    A plant-derived oil mixture from coconut that acts as an emollient and solvent. It helps dissolve or carry active ingredients and improves how the medicine spreads or absorbs in topical formulations.
  • UNII 609A3V1SUA
    A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
  • 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 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII 4P26HG1S5W
    A plant extract from sunflower sprouts used in formulations as an antioxidant and preservative to help maintain product stability and prevent degradation of active ingredients.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII S4V5BS6GCX
    A synthetic oily liquid used as an emollient and solvent in topical medications. It helps dissolve active ingredients and creates a smooth, spreadable texture on the skin.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • UNII ML9LGA7468
    A naturally-derived alcohol used as a preservative and fragrance in medicines. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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 06YD7896S3
    A waxy, fatty substance derived from stearic acid. It acts as a thickener and texture modifier in medicines, helping control how quickly the drug dissolves and improving the product's firmness and consistency.
  • 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.

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

The official label also statesInactive ingredients dicaprylyl carbonate, isononyl isononanoate, coco-caprylate, C12-15 alkyl benzoate, ethylhexyl palmitate, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, magnesium stearate, argania spinosa kernel oil, tocopherol, caesalpinia spinosa fruit pod extract, helianthus annuus (sunflower) sprout extract, sodium hyaluronate, tocopheryl acetate, maltodextrin, phenethyl alcohol, polyhydroxystearic acid, trinydroxystearin, mica, aqua (water), ethylhexylglycerin, sodium benzoate, iron oxides (CI 77499), titanium dioxide (Cl 77891)

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 eachPer 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
Suzanne Organics Tinted Mineral Sunscreen Broad Spectrum SPF 25 - Sand 220 mg/mL 15435-0300-04 SLC 60 ml — — FDA listed —
Suzanne Organics Tinted Mineral Sunscreen Broad Spectrum SPF 25 - Bronze 220 mg/mL 15435-0310-04 SLC 60 ml — — FDA listed —
Active Argan 365 Spf 30 Broad Spectrum Activated Argan Complex 220 mg/mLthis 70803-0250-01 SIBORG 1 bottle — — FDA listed —
Gin Amber Beauty Mineral Sunscreen Broad Spectrum SPF 25 BB Cream 220 mg/mL 82618-0320-04 Gin 59 ml — — FDA listed —
SPF 30 Daily Sunscreen 220 mg/mL 81136-0001-01 Brand 1 tube — — FDA listed —
Mineral Sun Drops 220 mg/mL 69949-0025-01 Synchronicity 1 bottle — — FDA listed —
Odacite Color Balm - Golden Hour 220 mg/mL 82088-0500-02 Odacite 1 jar — — FDA listed —
Odacite Color Balm - Sienna Rose 220 mg/mL 82088-0499-02 Odacite 1 jar — — FDA listed —
Charlis Neutral Tinted Face Moisturizer Mineral Sunscreen SPF 25 220 mg/mL 85566-0322-01 CHARLIS 1 jar — — FDA listed —
Odacite Color Balm - Bronze Jolie 220 mg/mL 82088-0498-02 Odacite 1 jar — — FDA listed —
Dolce Glow Body Balm 220 mg/mL 83869-2167-02 Dolce 1 jar — — FDA listed —
Odacite Color Balm - Frosted Petal 220 mg/mL 82088-0501-02 Odacite 1 jar — — 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

🏛️
2019
On the market since
May 2019
📍
2026
Currently FDA-listed
7 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 ACTIVE ARGAN 365 SPF 30 BROAD SPECTRUM ACTIVATED ARGAN COMPLEX (this brand).

Top reported reactions

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

Age at onset

Neonate5
Infant8
Child28
Adolescent5
Adult110
Elderly192

Reporter sex

1,941 reports

Serious outcomes

Hospitalization988
Life-threatening116
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 196 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
70803-0250-01 You're viewing this 1 BOTTLE in 1 BOX (70803-250-01) / 50 mL in 1 BOTTLE 2019-05-01 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 70803-250-01, 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: 70803-0250-01, written without dashes as 70803025001. 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 70803-0250-01, the first segment (70803) is the labeler code FDA assigned to SIBORG LLC; the middle segment (0250) 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 SIBORG LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SIBORG LLC 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 31 words ▾

Uses Helps prevent sunburn If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun See Directions

⏱️ Dosage and Administration 95 words ▾

Directions apply liberally and evenly 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if 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 value of 15 or higher and other sun protection measures including: Sun Protection Measures: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses Children under 6 months of age: Ask a doctor

⚠️ Warnings 54 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 a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 66 words ▾

Active ingredients Zinc oxide 22% Purpose Sunscreen Inactive Ingredients Inactive ingredients dicaprylyl carbonate, isononyl isononanoate, coco-caprylate, C12-15 alkyl benzoate, ethylhexyl palmitate, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, magnesium stearate, argania spinosa kernel oil, tocopherol, caesalpinia spinosa fruit pod extract, helianthus annuus (sunflower) sprout extract, sodium hyaluronate, tocopheryl acetate, maltodextrin, phenethyl alcohol, polyhydroxystearic acid, trinydroxystearin, mica, aqua (water), ethylhexylglycerin, sodium benzoate, iron oxides (CI 77499), titanium dioxide (Cl 77891)

🧪 Inactive Ingredients 59 words ▾

Inactive Ingredients Inactive ingredients dicaprylyl carbonate, isononyl isononanoate, coco-caprylate, C12-15 alkyl benzoate, ethylhexyl palmitate, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, magnesium stearate, argania spinosa kernel oil, tocopherol, caesalpinia spinosa fruit pod extract, helianthus annuus (sunflower) sprout extract, sodium hyaluronate, tocopheryl acetate, maltodextrin, phenethyl alcohol, polyhydroxystearic acid, trinydroxystearin, mica, aqua (water), ethylhexylglycerin, sodium benzoate, iron oxides (CI 77499), titanium dioxide (Cl 77891)

🎯 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 ↗
← 70799-0000-01 · Alfasigma 70807-0503-12 · Elite →
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.