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Rationale The Brilliance Tinted Serum SPF 50 ZINC OXIDE 245 mg/mL Emulsion, 1.5 mL — NDC 83108-0200-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Rationale The Brilliance Tinted Serum SPF 50 ZINC OXIDE 245 mg/mL Emulsion, 1.5 mL — NDC 83108-200-01 (Billing 83108-0200-01)

by RATIONALE GROUP PTY LTD · 1.5 mL in 1 PACKET

This is a package of 1.5 mL of Rationale The Brilliance Tinted Serum SPF 50 ZINC OXIDE 245 mg/mL Emulsion from RATIONALE GROUP PTY LTD, marketed since Feb 2026 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.

NDC 83108-0200-01
🏷️ FDA NDC (as labeled) 83108-200-01 billing pads the product segment with a zero
This package
Contains1.5 mL Pack sizes4 compare ↓
Main listing for product 83108-200 · Also comes in: 5 mL 83108-200-05 15 mL 83108-200-15 30 mL 83108-200-30
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 83108-200-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
83108 labeler · 200 product · 01 package
Package marketed since
Feb 17, 2026
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2027
Barcode (UPC)
9359782006399, 9359782005422
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83108-200-01
Product NDC 83108-200
11-digit billing NDC 83108020001
UNII SOI2LOH54Z
UPC 9359782006399, 9359782005422
Application # M020
SPL Set ID 5c38506b-1533-435f-87a6-0452bae5b29f
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 2026-02-17
Route TOPICAL
Dosage form EMULSION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 83108-200-01 — 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 → 83108-0200-01. 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.

Clinical

🧪 What is this product?

This is a tinted sunscreen emulsion applied to the skin that contains zinc oxide as its active ingredient. Zinc oxide is a mineral UV filter commonly used in sunscreen products to help reflect and scatter ultraviolet rays from the sun. The product is marketed as an over-the-counter sunscreen under FDA's monograph rules for sunscreen drugs, meaning it follows the agency's established category standards rather than being individually reviewed. It combines sun protection with a tinted formulation for cosmetic coverage.

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.

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 mLPer 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: 5 mL 15 mL 30 mL
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
83108-0200-01 You're viewing this Main listing 1.5 mL in 1 PACKET Sample 2026-02-17 — Active
83108-0200-05 83108-200-05 1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC Sample 2026-02-17 — Active
83108-0200-15 83108-200-15 1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC 2026-02-17 — Active
83108-0200-30 83108-200-30 1 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC 2026-02-17 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1.5 mL — 1.5 ml in 1 packet.
What NDC number is used to bill for this package of Rationale The Brilliance Tinted Serum SPF 50 ZINC OXIDE 245 mg/mL Emulsion?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rationale The Brilliance Tinted Serum SPF 50 245 mg/mLthis 83108-0200-01 RATIONALE 1.5 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

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 P01OUT964K
    A fragrant plant-derived alcohol used as a flavoring agent and fragrance component in medicines. It provides taste and aroma to make the product more pleasant to use.
  • UNII BK1IU07GKF
    A steroid compound naturally found in skin and other tissues. It serves as a precursor ingredient that helps stabilize the formulation and may support the product's intended chemical stability.
  • UNII AI3L60HQ81
    A plant-derived substance from the model plant Arabidopsis thaliana, used as a natural binder or thickening agent to help hold the medicine together and improve its texture and stability.
  • UNII 4T235SD5XE
    A plant-based ingredient derived from bambara groundnut seeds. It functions as a binder and filler in tablets and capsules, helping hold the medicine together and add bulk to reach the proper dose size.
  • UNII 39W1PKE3JI
    Bergamot oil is a citrus extract from bergamot orange peel. It's used as a flavoring and fragrance agent to improve taste and aroma in medicines.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII 2U4T60A6YD
    Boron nitride is a synthetic mineral compound. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
  • 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 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 S4255P4G5M
    Calcium silicate is a white powder made from calcium and silicon compounds. It acts as an anti-caking agent and flow aid, helping powder ingredients move smoothly during tablet or capsule manufacturing.
  • UNII UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • 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 GSA2TXZ34G
    A synthetic polymer made from castor oil and a chemical linker, used as a coating or binder in medications to control how and when the active ingredient is released in the body.
  • UNII 9TLV70SV6I
    A natural essential oil extracted from bitter orange peel, used as a flavoring agent to mask unpleasant tastes and improve the palatability of medicines.
  • UNII 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII 1F2S8T535O
    A synthetic polymer made from fatty acids and a chemical compound that binds ingredients together. It works as a binder and film-former in solid dosage forms, helping hold tablets together and coat their surface.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 45ASM2L11M
    A synthetic ingredient derived from glutamic acid and stearic acid. It acts as an emulsifier and surfactant, helping oils and water mix smoothly in the medication formulation.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII S3KFG6Q5X8
    An organic chemical compound used as a UV filter in topical formulations. It helps protect the medicine or product from degradation caused by sunlight exposure during storage and use.
  • 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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • 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 GFD7C86Q1W
    A natural oil extracted from citrus peels, (+)-limonene is used as a flavoring agent and solvent in medicines. It helps dissolve active ingredients and provides a lemon or orange taste.
  • UNII D81QY6I88E
    Linalool is a natural fragrant oil found in plants like lavender and citrus. It's used in medicines as a flavoring agent and to mask unpleasant tastes or smells.
  • UNII 5K47SSQ51G
    A fragrant compound found in plants like lavender and bergamot. It's used as a flavoring and aroma agent to improve the taste and smell of medications.
  • UNII 24GB753W3B
    A natural ingredient derived from white lupin seeds. It functions as a binder and thickener, helping hold the medicine together and give it the right texture in solid or liquid formulations.
  • 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 461N1O614Y
    A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
  • UNII 3K0J1S7QGC
    A fragrant essential oil derived from geranium flowers, used as a flavoring and fragrance agent to improve the taste and aroma of medicines.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • 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 996299PUKB
    Pinene is a natural oil compound found in pine trees and other plants. It's used in medicines as a flavoring agent and to help mask bitter or unpleasant tastes.
  • UNII 8Y19QCY6I4
    Pongamol is a naturally occurring compound derived from Pongamia pinnata plant seeds. In medicines, it serves as an antimicrobial and antioxidant agent to help preserve product stability and prevent degradation.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII Z6C6FF3Y9R
    A mineral compound used as an anticaking agent and flow aid. It prevents clumping and helps the medicine powder flow smoothly during manufacturing and packaging.
  • UNII 06XEA2VD56
    Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
  • UNII KM7N50LOS6
    Tin oxide is an inorganic mineral compound used in medicines as a colorant and opacifying agent. It provides white or off-white color to tablets, capsules, and coatings while helping make formulations less transparent.
  • 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 A3LZF0L939
    Tridecane is a clear, colorless liquid hydrocarbon derived from petroleum. It acts as a solvent and lubricant in medicines, helping distribute active ingredients evenly and reducing friction during manufacturing and tablet compression.
  • UNII LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • UNII JV0QT00NUE
    Undecane is a clear liquid hydrocarbon derived from petroleum. It functions as a solvent and processing aid in medicines, helping dissolve or suspend active ingredients and improve how the drug is manufactured and delivered.
  • UNII CHI530446X
    Vanillin is a natural or synthetic aromatic compound that gives vanilla flavor. It's used in medicines as a flavoring agent to mask bitter tastes and improve how the medicine tastes.
  • 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.

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

The official label also statesUndecane, Caprylic/Capric Triglyceride, Tridecane, Aqua (Water), Butyloctyl Salicylate, Lauryl PEG-IO Tris(Trimethylsi- loxy)silylethyl Dimethicone, Coco-Caprylate/• Caprate, Polyhydroxystearic Acid, Boron Nitride, Capryloyl Glycerin/Sebacic Acid Copolymer, Ethylhexyl Methoxycrylene, Helianthus Annuus (Sunflower) Seed Oil, Dimethicone, Methyl Methacrylate Crosspolymer, Sodium Potassium Aluminum Silicate, Pentylene Glycol, Silica, Propanediol, 7-Dehydrocholesterol, Bisabolol, Sodium Chloride, Polyurethane-79, Maltodextrin, Cetearyl Dimethicone Crosspolymer, Mica, Copernicia Cerifera (Carnauba) Wax, I,2•HexanedioI, Fragrance/Parfum, Pongamol, C12-15 Alkyl Benzoate, Calcium Silicate, Voandzeia Subterranea Seed Extract, Glycerin, Lupinus Albus Seed Extract, Caprylhydroxamic Acid Disodium EDTA, Melanin, Tin Oxide,Phenoxyethanol, Lecithin, Triethoxycapry- lylsilane, Plankton Extract, Micrococcus Lysate, Arabidopsis Thaliana Extract, Octyldodecanol, Pelargonium Graveolens Flower Oil, PolyglyceryI•6 Polyricinoleate, Tocopherol, Ethylhexylglycerin, Dilinoleic Acid/ButanedioI Copolymer, Disodium Stearoyl Glutamate, Castor Oil/IPDI Copolymer, Sodium Hyaluronate, Sorbitan Oleate, Acetyl Tetrapeptide-22, Limonene, Citrus Aurantium Peel Oil, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Linalyl Acetate, Vanillin, Linalool, Pinene, Lavandula OiVExtract, Citronellol, CI 77891 (Titanium Dioxide), CI 77492 (Iron Oxides), Cl 77491 (Iron Oxides), Cl 77499 (Iron Oxides), Cl 42090 (Blue 1 Lake).

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

LabelerRATIONALE GROUP PTY LTD
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83108
First marketedFeb 2026
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from RATIONALE GROUP PTY LTD labeler code 83108

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 words ▾

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

⏱️ Dosage and Administration 92 words ▾

Directions Apply liberally 15 minutes before sun exposure. Reapply At least every 2 hours Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin ageing. 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.

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 7 words ▾

Active Ingredient Zinc Oxide 24.50% Purpose Sunscreen

🧪 Inactive Ingredients 157 words ▾

Inactive ingredients Undecane, Caprylic/Capric Triglyceride, Tridecane, Aqua (Water), Butyloctyl Salicylate, Lauryl PEG-IO Tris(Trimethylsi- loxy)silylethyl Dimethicone, Coco-Caprylate/• Caprate, Polyhydroxystearic Acid, Boron Nitride, Capryloyl Glycerin/Sebacic Acid Copolymer, Ethylhexyl Methoxycrylene, Helianthus Annuus (Sunflower) Seed Oil, Dimethicone, Methyl Methacrylate Crosspolymer, Sodium Potassium Aluminum Silicate, Pentylene Glycol, Silica, Propanediol, 7-Dehydrocholesterol, Bisabolol, Sodium Chloride, Polyurethane-79, Maltodextrin, Cetearyl Dimethicone Crosspolymer, Mica, Copernicia Cerifera (Carnauba) Wax, I ,2•HexanedioI, Fragrance/Parfum, Pongamol, C12-15 Alkyl Benzoate, Calcium Silicate, Voandzeia Subterranea Seed Extract, Glycerin, Lupinus Albus Seed Extract, Caprylhydroxamic Acid Disodium EDTA, Melanin, Tin Oxide,Phenoxyethanol, Lecithin, Triethoxycapry- lylsilane, Plankton Extract, Micrococcus Lysate, Arabidopsis Thaliana Extract, Octyldodecanol, Pelargonium Graveolens Flower Oil, PolyglyceryI•6 Polyricinoleate, Tocopherol, Ethylhexylglycerin, Dilinoleic Acid/ButanedioI Copolymer, Disodium Stearoyl Glutamate, Castor Oil/IPDI Copolymer, Sodium Hyaluronate, Sorbitan Oleate, Acetyl Tetrapeptide-22, Limonene, Citrus Aurantium Peel Oil, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Linalyl Acetate, Vanillin, Linalool, Pinene, Lavandula OiVExtract, Citronellol, CI 77891 (Titanium Dioxide), CI 77492 (Iron Oxides), Cl 77491 (Iron Oxides), Cl 77499 (Iron Oxides), Cl 42090 (Blue 1 Lake).

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 8 words ▾

Do not use On damaged or broken skin.

📄 When Using This Product 13 words ▾

When using this product Keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if Rash occurs.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

📄 Package Label / Principal Display Panel 24 words ▾

Package Labeling 30mL: Outer Package2 Inner Package2

Package Labeling 15mL: Outer Package Inner Package

Package Labeling 5mL Sample : OuterSample InnerSample

Package Labeling: Label03

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

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 RATIONALE GROUP PTY 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 bottle (83108-0200-05), 1 bottle (83108-0200-15), 1 bottle (83108-0200-30). 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?
RATIONALE GROUP PTY LTD is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 83108-0100-00 · Rationale 83108-0210-00 · RATIONALE →
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.