Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30 Titanium Dioxide, Zinc Oxide 9.693 g/50.28g; 2.169 g/50.28g Paste, 50.28 g
Other active recalls for Titanium Dioxide, Zinc Oxide (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
This is a topical sunscreen paste marketed as an over-the-counter monograph drug under FDA's established rules for sunscreen products. It contains two mineral UV filters, titanium dioxide and zinc oxide, which are commonly used to protect skin from ultraviolet radiation by reflecting and scattering UV light. The product is formulated as a tinted moisturizer with a sun protection factor of 30, combining sunscreen protection with cosmetic moisturizing ingredients applied directly to the skin.
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Supplement & herbal interactions
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💊 What it looks like
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🧪 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.
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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.
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UNII LMI26O6933
Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
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UNII I1BJ961J2E
A fragrant essential oil derived from the amyris tree, used as a flavoring and fragrance agent to improve the taste and smell of medicines.
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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.
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UNII H7UGK1GJCU
Aspalathus linearis leaf is a plant extract from rooibos tea. It's used in medicines as a natural flavor and color agent, and may help preserve the product's stability.
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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 K8NU647RJ0
Behenyl behenate is a waxy ester derived from behenic acid. It acts as a lubricant and glidant in tablets and capsules to reduce friction during manufacturing and improve powder flow.
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UNII WL0328HX19
A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
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UNII N7YC58165T
A synthetic polymer made from glycerin and sebacic acid, used as a film-former and binder in medications. It helps hold tablet or capsule ingredients together and may coat the product for controlled release.
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UNII D5340Y2I9G
Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
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UNII T7EU0O9VPP
Citral is a natural oil compound found in lemon and citrus plants. It's used in medicines as a flavoring agent and to add pleasant lemon or citrus scent to the product.
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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.
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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.
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UNII ANA2NCS6V1
A natural oil derived from macadamia nuts, used as an emollient and conditioning agent. It helps soften the product's texture and improve how it spreads or absorbs on skin or mucous membranes.
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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.
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UNII C690YC9N2Z
Galbanum is a resin obtained from plant sap, used as a flavoring agent and fragrance component in medicines. It adds taste and aroma to make medications more palatable.
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UNII 5Q1I94P4WG
A fragrant essential oil derived from geranium plants, used as a flavoring and fragrance agent to improve the taste and smell of medicines.
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UNII SAS9Z1SVUK
A natural oil extracted from ginger root that adds flavor and aroma to the medicine. It may also serve as a preservative or help mask unpleasant tastes in the formulation.
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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 B68LJT9544
A fatty acid derivative used as a preservative and antimicrobial agent in topical medicines. It helps prevent bacterial and fungal growth to maintain product stability and safety.
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UNII TM2TZD4G4A
A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
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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 SZH16H44UY
A fragrant essential oil extracted from juniper berries, used as a flavoring agent and fragrance component in medicines to improve taste or aroma.
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UNII 113171Q70B
Lauroyl lysine is a compound made by combining an amino acid (lysine) with a fatty acid (lauric acid). It works as a glidant and lubricant to help powder particles flow smoothly during manufacturing and tablet compression.
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UNII 9RES347CKG
A fragrant oil derived from lavandin plants, used as a flavoring and aromatic agent to improve the taste and smell of medicines.
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UNII D2QHA03458
A fermented ingredient made by culturing beneficial bacteria in radish root extract. It acts as a natural preservative and humectant, helping keep the product fresh and maintain moisture in the formula.
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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.
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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.
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UNII 2XIW34BN6O
A fragrant oil derived from litsea cubeba fruit, used as a flavoring agent and aromatic ingredient to improve the taste and smell of the medicine.
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UNII 930626MWDL
A plant extract from goji berries used as a natural coloring agent and flavor enhancer in medicines. It may add color and taste while serving as a source of beneficial plant compounds in the formulation.
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UNII 817L1N4CKP
Malic acid is a naturally occurring organic acid found in fruits. It works as a buffer and flavor agent to maintain the medicine's pH balance and add tartness to the product.
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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.
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UNII D4N66T98C2
A synthetic ester derived from long-chain fatty acids, used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product's texture while improving how the medicine spreads on skin.
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UNII AKN3KSD11B
Orange oil obtained by cold pressing orange peel. It serves as a flavoring agent and fragrance in medicines to improve taste and aroma.
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UNII F3IN55X5PO
A plant-derived essential oil from patchouli leaves. It serves as a fragrance and flavoring agent to improve the taste and smell of the medicine.
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UNII YPM0ZOC2HR
A synthetic emulsifier derived from glycerin and castor oil. It helps mix oil and water-based ingredients together in the formulation to create a uniform product and improve texture.
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UNII YXH47AOU0F
A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
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UNII CLV24I3T1D
A plant extract from pomegranate root bark used as a natural coloring agent and flavoring component in medicines. It may also help preserve the product and provide mild astringent properties to the formulation.
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UNII 978D8U419H
A yeast strain commonly used in food and pharmaceutical manufacturing. In medicines, it may serve as a filler, culture medium carrier, or source of beneficial compounds in probiotic formulations.
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UNII K49155WL9Y
Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
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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 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.
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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.
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UNII 9M9P32M01L
Vetiver oil is a fragrant plant extract from vetiver grass roots. It's used in medicines as a flavoring agent and to mask unpleasant tastes or smells in the formulation.
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UNII C34U15ICXA
A plant extract from grape seeds that acts as an antioxidant and preservative in medications. It helps protect the active ingredients from degrading and extends the product's shelf life.
45 inactive ingredients listed in the exact product block matched to this NDC.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30 9.693 g/50.28g; 2.169 g/50.28gthis 65278-0104-01 | June | 50.28 g | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 65278-0104-01 You're viewing this | 50.28 g in 1 TUBE (65278-104-01) | 2021-09-08 | Active |
| 65278-0104-02 | 50.28 g in 1 CARTON (65278-104-02) | 2021-09-08 | Active |
Pack size FAQ
What quantity is in NDC 65278-0104-01?
What is the difference between NDC 65278-0104-01 and NDC 65278-0104-02?
What NDC number is used to bill for this package of Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30 Titanium Dioxide, Zinc Oxide 9.693 g/50.28g; 2.169 g/50.28g Paste?
🧭 About this NDC listing & data coverage
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. |
Questions about this listing
Is this NDC FDA-approved?
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Is the NDC printed on the package the same as the 11-digit billing NDC?
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Where does this data come from?
📄 FDA label — Drug Facts FDA SPL
🎯 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 Use daily after cleanser or serum for protective moisture and younger-looking skin. Apply to face and neck liberally 15 minutes before sun exposure. Reapply at least every two hours Sun Protection Measures.
Spending time in the sun increases your risk of skin cancer and early 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 sleeve shirts, pants, hats and sunglasses Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Children under 6 months: Ask a doctor
⚠️ Warnings ▾
Warnings For external use only
🧪 Active Ingredient ▾
Active Ingredients Titanium Dioxide........... 4.31% Zinc Oxide....................19.27%
🧪 Inactive Ingredients ▾
Inactive Ingredients Ethyl Macadamiate, Caprylic/Capric Triglyceride, Saccharomyces Ferment, Coco Caprylate/Caprate, Behenyl Behenate, Sorbitol/Sebacic Acid Copolymer Behenate, Polyhydroxystearic Acid, Octyldodecyl Erucate, Euphorbia Cerifera (Candelilla) Wax, Fragrance/Parfum, Lauroyl Lysine, Iron Oxides, Stearic Acid, Alumina, Glyceryl Caprylate, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil , Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polyglyceryl-6 Polyricinoleate, Dilinoleic Acid/Butanediol Copolymer, Tocopherol, Glyceryl Undecylenate, Malic Acid, Castor Oil/IPDI Copolymer, Glycerin, Lycium Barbarum Fruit Extract , Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract , Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Limonene, Linalool, Citral.
🎯 Purpose ▾
Sunscreen