Umbra Tinte Mineral Cream SPF 30 Zinc Oxide 12 g/60mL Cream
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
This is a topical cream sunscreen containing zinc oxide, an over-the-counter monograph product marketed under FDA's established rules for sunscreen ingredients. Zinc oxide is a mineral UV filter that is commonly used in sunscreens to help reflect and scatter ultraviolet light away from the skin. The product is formulated to deliver sun protection factor 30 (SPF 30) in a cream base applied to exposed skin.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 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 5C5403N26O
Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
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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.
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UNII 8XPW32PR7I
Astaxanthin is a reddish pigment from algae and other organisms, used in medicines as a colorant and antioxidant to maintain product stability and appearance during storage.
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UNII N4G8379626
A plant-based oil extracted from rapeseed (also called canola). It's used in medicines as an emulsifier and lubricant to help blend ingredients together and improve how the product flows and feels.
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UNII 7J5R5W72QM
C9-12 alkane is a clear, colorless liquid hydrocarbon mixture derived from petroleum. In medicines, it serves as a solvent, lubricant, or component in liquid formulations to help dissolve or suspend active ingredients.
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UNII O5R6DK2M9K
A plant oil derived from tea plant seeds. It acts as an emollient and natural carrier in formulations, helping to soften and smooth the product while delivering active ingredients to skin or mucous membranes.
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UNII I670DAL4SZ
A preservative that fights bacteria and fungi. It keeps medicines and topical products stable and safe from microbial contamination during storage and use.
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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 X687XDK09L
A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
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UNII HTC7G3S2PV
Ethylhexyl olivate is an emollient and skin-conditioning agent derived from olive oil. It helps soften the product's texture and improves how the medicine 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 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 31T0FF0472
A red microalgae used as a natural colorant and source of astaxanthin pigment in medications and supplements. It adds color to tablets and capsules.
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UNII 2NX48Z0A9G
Icodextrin is a glucose polymer derived from starch. It acts as a thickening agent and osmotic agent in medicines, helping to control texture and absorption in formulations like eye drops or injectable solutions.
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UNII 724GKU717M
Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
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UNII 24H4NWX5CO
Kaolin is a naturally occurring clay mineral. It's used in tablets and capsules as a filler and absorbent to add bulk, improve texture, and help bind ingredients together.
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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 U946SH95EE
Milk thistle is a plant extract used in some supplements and herbal formulations. It may act as an active botanical ingredient rather than a traditional inactive excipient, though it can also serve as a filler or binder in tablet or capsule preparations.
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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 46P231IQV8
A synthetic emulsifier derived from glycerin and fatty acids. It helps blend oil and water-based ingredients together in cosmetic and pharmaceutical formulations to create stable, uniform products.
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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 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 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.
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UNII 9S8867952A
A plant-derived oil from raspberry seeds used as an emollient and skin-conditioning agent in topical formulations. It helps soften the product texture and improve skin feel.
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UNII WDO4TLS35F
A plant-based oil extracted from marula tree seeds, used as an emollient and skin-conditioning agent in topical formulations to help soften and protect the skin surface.
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UNII 87GE52P74G
Sea salt is sodium chloride harvested from seawater. It acts as a flavoring agent and preservative in medications, helping enhance taste and prevent microbial growth.
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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.
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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 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.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII GW89575KF9
Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
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UNII 9LBV3F07AZ
A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during storage.
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UNII 5EHL50I4MY
A sodium salt compound used as a chelating agent in medicines. It binds to metals and minerals to improve stability, prevent discoloration, and help the medication stay effective longer.
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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 EJ27X76M46
Ubidecarenone is a naturally occurring compound found in cells that helps produce energy. In medicines, it acts as an antioxidant and may help stabilize the product while supporting cellular function in the body.
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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 JHQ6158A7R
A natural liquid extracted from wine grapes, used as a flavoring and colorant to improve taste and appearance of the medicine.
38 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 |
|---|---|---|---|---|---|---|
| Umbra Tinte Mineral Cream SPF 30 12 g/60mLthis 69455-0167-10 | Drunk | 1 tube | — | — | FDA listed | — |
| Umbra Sheer Mineral Cream SPF 30 12 g/60mL 69455-0163-10 | Drunk | 1 tube | — | — | FDA listed | — |
| Umbra Cocoa Mineral Cream SPF 30 12 g/60mL 69455-0166-10 | Drunk | 1 tube | — | — | 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?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69455-0167-10 You're viewing this | 1 TUBE in 1 BOX (69455-167-10) / 60 mL in 1 TUBE | 2024-06-11 | Active |
| 69455-0167-20 | 1 CARTON in 1 TUBE (69455-167-20) / 5 mL in 1 CARTON | 2024-06-11 | Active |
| 69455-0167-30 | 2 mL in 1 PACKET (69455-167-30) | 2024-06-11 | Active |
Pack size FAQ
What quantity is in NDC 69455-0167-10?
What NDC number is used to bill for this package of Umbra Tinte Mineral Cream SPF 30 Zinc Oxide 12 g/60mL Cream?
🧭 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?
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
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 For sunscreen use: 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 aging. To decrease the 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 children under 6 months: Ask a doctor.
⚠️ Warnings ▾
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 product is swallowed, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information Protect this product from excessive heat and direct sun.
🧪 Active Ingredient ▾
Active Ingredient Zinc Oxide 20%
🧪 Inactive Ingredients ▾
Inactive ingredients Water, Ethylhexyl Olivate, Squalane, C9-12 Alkane, Propanediol, Polyglyceryl-3 Diisostearate, Glycerin, Polyglyceryl-6 Polyricinoleate, Silica, Disteardimonium Hectorite, Lauroyl Lysine, Kaolin, Sclerocarya Birrea Seed Oil, Camellia Sinensis Seed Oil, Coco-Caprylate/Caprate, Rubus Idaeus (Raspberry) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Acacia Senegal Gum, Silybum Marianum Fruit Extract, Tetrahexyldecyl Ascorbate, Vitis Vinifera (Grape) Juice Extract, C12-15 Alkyl Benzoate, Haematococcus Pluvialis Extract, Ubiquinone, Astaxanthin, Dextrin, Sea Water, Brassica Campestris (Rapeseed) Seed Oil, Tocopheryl Acetate, Potassium Sorbate, Chlorphenesin, Sea Salt, Sodium Benzoate, Tetrasodium Glutamate Diacetate, Phenoxyethanol, Sodium Hydroxide, Tocopherol, Iron Oxides
🎯 Purpose ▾
Purpose Sunscreen