Bye Foundation Full Coverage Moisturizer SPF 50 Medium TITANIUM DIOXIDE AND ZINC OXIDE 9 g/100mL; 6.3 g/100mL Cream, 30 mL
by IT COSMETICS, LLC · 30 mL in 1 TUBE (69259-0412-1)
NDC 69259-0412-01
🏷️ FDA NDC (as labeled)
69259-0412-1
billing pads the package segment with a zero
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 →
🆔 Identity & classification
FDA NDC (as labeled)
69259-0412-1
Product NDC
69259-0412
11-digit billing NDC
69259041201
UNII
SOI2LOH54Z, 15FIX9V2JP
Application #
M020
SPL Set ID
b098aba3-dad6-4421-a943-e88ce5e2f8d6
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2017-08-23
Route
TOPICAL
Dosage form
CREAM
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs?
The FDA registers this code as 69259-0412-1 — 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 → 69259-0412-01. 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
LabelerIT COSMETICS, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code69259
First marketedAug 2017
Product typeHuman Otc Drug
Portfolio57 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?
Bye Foundation Full Coverage Moisturizer SPF 50 is a topical cream containing the active ingredients titanium dioxide and zinc oxide. These mineral compounds are commonly used in sunscreen products to protect skin from ultraviolet (UV) radiation by reflecting and scattering UV rays away from the skin. This product combines sun protection with a moisturizing foundation base and is marketed as an over-the-counter drug under FDA's monograph rules for sunscreen products.
Patient education
Supplement & herbal interactions
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.
💬 Questions about TITANIUM DIOXIDE AND ZINC OXIDE?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
brown
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 TR046Y3K1G
A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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UNII ZY81Z83H0X
Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
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UNII 5QB0T2IUN0
Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
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UNII PQ6CK8PD0R
Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
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UNII 6VNO72PFC1
A natural oil extracted from avocado fruit. It's used in medicines as an emollient and carrier to help dissolve or deliver active ingredients and improve how the product feels on skin or mucous membranes.
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UNII 6SO6U10H04
Biotin is a B-vitamin used as a nutritional supplement in some medications. It may also serve as a colorant or marker in formulations.
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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.
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UNII 3XUS85K0RA
Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
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UNII 75D21FL1PI
A synthetic liquid derived from butylene glycol and fatty acids. It acts as an emollient and solvent to help dissolve or suspend active ingredients, improving texture and absorption in topical or oral formulations.
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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.
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UNII 776XM7047L
Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
-
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.
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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 11X758JML9
A naturally occurring amino acid compound used as a dietary supplement ingredient. It may serve as a filler or active support ingredient in formulations designed to support cellular energy production.
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UNII R4KO0DY52L
Chlorhexidine is an antimicrobial chemical compound used as a preservative in medicines. It prevents bacterial and fungal growth to keep the product safe and stable during storage.
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UNII 97C5T2UQ7J
Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
-
UNII 39EHZ05V39
Cholesteryl chloride is a cholesterol derivative used in pharmaceutical formulations as an emulsifier and penetration enhancer. It helps stabilize mixtures of oil and water-based ingredients in topical or specialized delivery systems.
-
UNII JD5KDN9464
A waxy substance derived from cholesterol that helps dissolve and distribute active ingredients evenly throughout the medicine. It acts as an emulsifier and thickening agent in creams, ointments, and other topical formulations.
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UNII 4313O7P4XW
Cholesteryl nonanoate is a cholesterol derivative used as a penetration enhancer and emollient in topical formulations. It helps active ingredients absorb through the skin and improves the texture and feel of creams and ointments.
-
UNII 95LLB1K2WE
A lipid compound derived from cholesterol and oleic acid. It functions as a film-former and emollient in topical formulations, helping create protective coatings and improve product texture and spreadability.
-
UNII 3CN01F5ZJ5
Chrysin is a plant-derived flavonoid compound used in medicines as a colorant and antioxidant. It helps prevent ingredient breakdown and may add a yellow or golden hue to the product.
-
UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
-
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 2R04ONI662
Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
-
UNII 935E97BOY8
Folic acid is a synthetic form of a B vitamin. In medicines, it's added as a nutritional supplement or to help prevent vitamin deficiency, especially in prenatal formulas.
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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.
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UNII 930MLC8XGG
A plant oil extracted from grape seeds, used as an emollient and solvent in medicines. It helps dissolve active ingredients and improve the texture and absorption of topical or liquid formulations.
-
UNII YR377U58W9
Grapefruit oil is a natural aromatic extract from grapefruit peel. It's used in medicines as a flavoring agent to improve taste and sometimes as a fragrance component.
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UNII W2ZU1RY8B0
A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
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UNII 4CG9F9W01Q
A synthetic fatty acid ester used as an emollient and skin-conditioning agent in topical medicines. It helps soften the product texture and improves how it spreads and absorbs into the skin.
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UNII S270N0TRQY
Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
-
UNII 2WID9OCG7P
A protein derived from fish skin or bones that has been broken down into smaller pieces to improve absorption. It functions as a structural agent and filler in supplements and topical formulations.
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UNII UZH29XGA8G
Lime oil is a natural fragrant liquid extracted from lime fruit peel. It's used in medicines as a flavoring agent to mask bitter or unpleasant tastes, making the medicine more pleasant to take.
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UNII NDT563S5VZ
A salt derived from the chemical compound EDTA, used as a chelating agent and preservative. It binds to metal ions in the formulation to prevent spoilage and maintain product stability.
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UNII DE08037SAB
Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
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UNII MJE3791M4T
N-hydroxysuccinimide is a chemical compound used as a reactive linker or coupling agent in pharmaceutical formulations. It helps facilitate chemical bonding between active ingredients and other molecules, or aids in drug stabilization and modification during manufacturing.
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UNII 2679MF687A
Niacin is a B vitamin used in medications as a nutritional supplement and pH buffer. It helps stabilize the product and may support formulation integrity during manufacturing and storage.
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UNII 25X51I8RD4
Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
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UNII 8PI54V663Y
Oatmeal is ground oat grain used as a natural filler and texture agent in medicines. It absorbs moisture, adds bulk to the formulation, and may help create a soothing base in topical products.
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UNII HO4ZT5S86C
A synthetic peptide derived from amino acids, used as a skin-conditioning agent and emollient in topical formulations to help soften and smooth the skin surface.
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UNII Q41S464P1R
A synthetic peptide (short protein-like molecule) used in skincare and cosmetic formulations as an active conditioning ingredient to help improve skin texture and appearance. It may function as a humectant or skin-conditioning agent in topical products.
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UNII 19F5HK2737
Pantothenic acid is a B vitamin used in some formulations as a nutritional supplement or to support stability. It may also serve as a buffer or pH adjuster in the medicine.
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UNII TA9UOF49CY
A colorless, odorless gas used as a propellant in metered-dose inhalers and aerosol sprays. It helps deliver the active medication as a fine mist into the lungs or onto the skin.
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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.
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UNII DR0K5NOJ4R
Phenyl trimethicone is a silicone-based lubricant and glidant. It helps powder particles flow smoothly and reduces friction during tablet or capsule manufacturing and filling.
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UNII 820DPX33S7
A synthetic emulsifier derived from glycerin and fatty acids. It helps mix oil and water-based ingredients together and keeps them evenly blended throughout the product.
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UNII 1VPU26JZZ4
Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
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UNII 0UI45XV0T6
A plant oil extracted from pomegranate seeds. It's used in formulations as an emollient to soften and smooth the product texture, and sometimes as a carrier or conditioning agent in topical preparations.
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UNII G2SH0XKK91
Retinol is a form of vitamin A derived from animal sources or synthesized in a lab. In medicines, it may serve as an active therapeutic ingredient in some formulations, though when listed as an excipient it functions as a skin-conditioning agent or antioxidant to help stabilize the product.
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UNII TLM2976OFR
Riboflavin is a B vitamin used as a colorant and nutritional additive in medications. It gives products a yellow color and may provide supplemental vitamin B2 value.
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UNII UMQ31C11AY
A protein derived from silk fibers that has been broken down into smaller chains. It acts as a binder and thickener in formulations, helping hold ingredients together and improve texture and consistency.
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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.
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UNII 01S2G2C1E4
Sorbitan isostearate is an emulsifier derived from sorbitol and isostearic acid. It helps mix oil and water-based ingredients together and keeps them blended throughout the medicine's shelf life.
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UNII 241ATL177A
Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
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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.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
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UNII M572600E5P
Thiamine hydrochloride is a form of vitamin B1, a water-soluble nutrient. It's added to some medicines as a nutritional supplement or active ingredient component, though when listed as an excipient it typically serves as a stabilizer or minor additive in the formulation.
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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 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.
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UNII 856YO1Z64F
Turmeric is a natural spice derived from the turmeric plant root. It serves as a colorant in medicines, giving products a yellow or golden appearance, and may also provide mild flavoring.
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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.
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UNII HA5CX6676U
White pine oil is a natural essential oil extracted from pine needles and wood. It's used in medicines as a flavoring agent and to provide a fresh, piney taste or aroma to the product.
62 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesWater, Snail Secretion Filtrate, Phenyl Trimethicone, Dimethicone, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Orbignya Oleifera Seed Oil, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Cyclohexasiloxane, Magnesium Sulfate, Aluminum Hydroxide, Stearic Acid, Polyglyceryl-4 Isostearate, Dimethicone/Vinyl Dimethicone Crosspolymer, Hexyl Laurate, Calcium Stearate, Caprylyl Glycol, Triethoxycaprylylsilane, Ethylhexylglycerin, Citrus Medica Limonum (Lemon) Peel Oil, Tocopheryl Acetate, Sorbitan Isostearate, Phenoxyethanol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, 1,2-Hexanediol, Disodium EDTA, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Aurantifolia (Lime) Oil, Cholesterol, Persea Gratissima (Avocado) Oil, Cholesteryl Oleyl Carbonate, Pinus Sylvestris Leaf Oil, Niacinamide, Punica Granatum Seed Oil, Vitis Vinifera (Grape) Seed Oil, Lactobacillus/Pumpkin Ferment Extract, Polymethylsilsesquioxane, Anthemis Nobilis Flower Water, Lactobacillus/Dipteryx Odorata Seed Ferment Filtrate, Avena Sativa (Oat) Kernel Extract, Panax Ginseng Root Extract*, Eucalyptus Globulus Leaf Oil, Saccharomyces/Rice Ferment Filtrate, Lactobacillus/Kelp Ferment Filtrate, Cholesteryl Nonanoate, Cholesteryl Isostearate, Cholesteryl Chloride, Curcuma Longa (Turmeric) Root Extract, Lactobacillus/Honeysuckle Flower/Licorice Root/Morus Alba Root/Pueraria Lobata Root/Schizandra Chinensis Fruit/Scutellaria Baicalensis Root/Sophora Japonica Flower Extract Ferment Filtrate, Magnolia Kobus Bark Extract, Glycine Soja (Soybean) Sprout Extract, Perfluorohexane, Glycerin, Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Hydrolyzed Silk, Perfluorodecalin, Silk Extract, Olea Europaea (Olive) Leaf Extract, Pentafluoropropane, Steareth-20, Citric Acid, Cocos Nucifera (Coconut) Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Hydrolyzed Collagen, Lactobacillus/Rice Ferment Filtrate, Lactobacillus/Centella Asiatica/Gleditsia Sinensis Thorn/Houttuynia Cordata Extract/Phellodendron Amurense Bark/Polygonum Cuspidatum Root/Prunella Vulgaris/Torilis Japonica Extract Ferment Filtrate, Lactobacillus Ferment, Bacillus/Cordyceps Sinensis/Ganoderma Lucidum/Inonotus Obliquus/Lentinus Edodes/Phellinus Linteus/Schizophyllum Commune/Tricholoma Matsutake Extract Ferment Filtrate, Phaseolus Angularis Seed Extract, Saccharomyces/Camellia Sinensis Extract Ferment Filtrate, Sodium Benzoate, Potassium Sorbate, Chrysanthemum Indicum Flower Extract, Diamond Powder, Caprylhydroxamic Acid, Artemisia Princeps Leaf Extract, Cinnamomum Cassia Bark Extract, Diospyros Kaki Leaf Extract, Morus Alba Fruit Extract, Aloe Barbadensis Leaf Extract, N-Hydroxysuccinimide, Pantothenic Acid, Biotin, Thiamine HCl, Retinyl Palmitate, Tocopherol, Niacin, Carnitine HCl, Ascorbic Acid, Riboflavin, Folic Acid, Palmitoyl Oligopeptide, Chrysin, Hydrolyzed Hyaluronic Acid, Palmitoyl Tetrapeptide-7, Chlorhexidine digluconate, Iron Oxides (CI 77492, CI 77491, CI 77499).
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 system | Per g | Per 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
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
🏛️
2017
On the market since
Aug 2017
📍
2026
Currently FDA-listed
9 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 Bye Bye Foundation Full Coverage Moisturizer SPF 50 Medium (this brand).
Top reported reactions
Age at onset
Reporter sex
Female · 100%
Serious outcomes
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69259-0412-01 You're viewing this | 30 mL in 1 TUBE (69259-0412-1) | 2017-08-23 | 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 69259-0412-1, 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: 69259-0412-01, written without dashes as 69259041201. 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 69259-0412-01, the first segment (69259) is the labeler code FDA assigned to IT COSMETICS, LLC; the middle segment (0412) 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 IT COSMETICS, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
IT COSMETICS, 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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses • Helps prevent 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 ▾
Directions • Apply liberally 15 minutes before sun exposure. • Reapply at least every 2 hour. • 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 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.
Children under 6 months of age: Ask a doctor.
⚠️ Warnings ▾
Warnings For external use only
📦 Storage and Handling ▾
Other information Protect the product in this container from excessive heat and direct sun.
🧪 Active Ingredient ▾
Active ingredients Titanium dioxide 9.0% Zinc oxide 6.3%
🧪 Inactive Ingredients ▾
Inactive ingredients Water, Snail Secretion Filtrate, Phenyl Trimethicone, Dimethicone, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Orbignya Oleifera Seed Oil, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Cyclohexasiloxane, Magnesium Sulfate, Aluminum Hydroxide, Stearic Acid, Polyglyceryl-4 Isostearate, Dimethicone/Vinyl Dimethicone Crosspolymer, Hexyl Laurate, Calcium Stearate, Caprylyl Glycol, Triethoxycaprylylsilane, Ethylhexylglycerin, Citrus Medica Limonum (Lemon) Peel Oil, Tocopheryl Acetate, Sorbitan Isostearate, Phenoxyethanol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, 1,2-Hexanediol, Disodium EDTA, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Aurantifolia (Lime) Oil, Cholesterol, Persea Gratissima (Avocado) Oil, Cholesteryl Oleyl Carbonate, Pinus Sylvestris Leaf Oil, Niacinamide, Punica Granatum Seed Oil, Vitis Vinifera (Grape) Seed Oil, Lactobacillus/Pumpkin Ferment Extract, Polymethylsilsesquioxane, Anthemis Nobilis Flower Water, Lactobacillus/Dipteryx Odorata Seed Ferment Filtrate, Avena Sativa (Oat) Kernel Extract, Panax Ginseng Root Extract*, Eucalyptus Globulus Leaf Oil, Saccharomyces/Rice Ferment Filtrate, Lactobacillus/Kelp Ferment Filtrate, Cholesteryl Nonanoate, Cholesteryl Isostearate, Cholesteryl Chloride, Curcuma Longa (Turmeric) Root Extract, Lactobacillus/Honeysuckle Flower/Licorice Root/Morus Alba Root/Pueraria Lobata Root/Schizandra Chinensis Fruit/Scutellaria Baicalensis Root/Sophora Japonica Flower Extract Ferment Filtrate, Magnolia Kobus Bark Extract, Glycine Soja (Soybean) Sprout Extract, Perfluorohexane, Glycerin, Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Hydrolyzed Silk, Perfluorodecalin, Silk Extract, Olea Europaea (Olive) Leaf Extract, Pentafluoropropane, Steareth-20, Citric Acid, Cocos Nucifera (Coconut) Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Hydrolyzed Collagen, Lactobacillus/Rice Ferment Filtrate, Lactobacillus/Centella Asiatica/Gleditsia Sinensis Thorn/Houttuynia Cordata Extract/Phellodendron Amurense Bark/Polygonum Cuspidatum Root/Prunella Vulgaris/Torilis Japonica Extract Ferment Filtrate, Lactobacillus Ferment, Bacillus/Cordyceps Sinensis/Ganoderma Lucidum/Inonotus Obliquus/Lentinus Edodes/Phellinus Linteus/Schizophyllum Commune/Tricholoma Matsutake Extract Ferment Filtrate, Phaseolus Angularis Seed Extract, Saccharomyces/Camellia Sinensis Extract Ferment Filtrate, Sodium Benzoate, Potassium Sorbate, Chrysanthemum Indicum Flower Extract, Diamond Powder, Caprylhydroxamic Acid, Artemisia Princeps Leaf Extract, Cinnamomum Cassia Bark Extract, Diospyros Kaki Leaf Extract, Morus Alba Fruit Extract, Aloe Barbadensis Leaf Extract, N-Hydroxysuccinimide, Pantothenic Acid, Biotin, Thiamine HCl, Retinyl Palmitate, Tocopherol, Niacin, Carnitine HCl, Ascorbic Acid, Riboflavin, Folic Acid, Palmitoyl Oligopeptide, Chrysin, Hydrolyzed Hyaluronic Acid, Palmitoyl Tetrapeptide-7, Chlorhexidine digluconate, Iron Oxides (CI 77492, CI 77491, CI 77499).
🎯 Purpose ▾
Purpose Sunscreen
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Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.