Mineral Lip Sunscreen Tinted Titanium Dioxide, Zinc Oxide 55 mg/g; 40 mg/g Stick, 1 cylinder
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 tinted lip sunscreen stick sold as an over-the-counter monograph drug product. It contains titanium dioxide and zinc oxide, mineral ingredients that are commonly used in sunscreens to block and reflect ultraviolet (UV) rays from the sun. The stick form is applied directly to the lips for topical sun protection. Both active ingredients function as physical UV filters in lip care products.
Patient education
Supplement & herbal interactions
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 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 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 U6XF9NP8HM
Aluminum stearate is a salt made from aluminum and stearic acid, a fatty substance. It works as a lubricant and glidant to help powder flow smoothly during manufacturing and tablet production.
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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 QN83US2B0N
Ascorbyl palmitate is a fat-soluble form of vitamin C used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down and becoming less stable over time.
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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 Q1LS2UJO3A
Ceresin is a purified mineral wax derived from ozocerite. It functions as a binding agent, thickener, and coating material in medicines to help hold ingredients together and provide texture or protective coating.
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UNII P5O01U99NI
A synthetic oily substance used as an emollient and texture enhancer in topical medicines. It helps soften the skin, improve product spreadability, and maintain a smooth, non-greasy feel.
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UNII 7LAB1GXG9G
Cetyl dimethylbutyl ether is a synthetic liquid used in medicines as an emollient and solvent. It helps dissolve active ingredients and improves how the medicine spreads or absorbs when applied to skin or taken orally.
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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 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.
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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.
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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.
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UNII R6G12EY23X
A synthetic liquid derived from coconut oil components combined with glycol. It acts as a solvent and emulsifier to help dissolve active ingredients and keep oil and water components mixed in the formulation.
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UNII 2865993309
Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
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UNII 42DG15CHXV
A natural plant wax derived from sunflower seeds. It serves as a lubricant and glidant to help powders flow smoothly during manufacturing and tablet formation.
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UNII 151Z7P1317
Hexyldecanol is a waxy alcohol derived from natural oils. It acts as an emollient and viscosity agent in topical formulations, helping create smooth texture and improve product spreadability on skin.
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UNII 0V595C1P6M
A synthetic oil made from fatty acids and alcohols. It acts as an emollient and lubricant in topical products, helping them spread smoothly on skin and improving texture.
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UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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UNII 184IZ28A2G
A silicone-based conditioning agent made by combining polyethylene glycol, polypropylene glycol, and dimethicone. It functions as an emulsifier and skin-conditioning ingredient to help blend oil and water components and improve product texture and spreadability.
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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 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 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
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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 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 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.
27 inactive ingredients listed in the exact product block matched to this NDC.
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 each | 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 |
|---|---|---|---|---|---|---|
| Mineral Based Sunscreen Stick Tinted 55 mg/g; 40 mg/g 81679-0220-30 | KATHLEEN | 30 g | — | — | FDA listed | — |
| Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85413-0212-45 | HALEM | 1 cylinder | — | — | FDA listed | — |
| Flash Invisible Stick 55 mg/g; 40 mg/g 85497-0219-30 | AEON | 30 g | — | — | FDA listed | — |
| Sun Plus Sun Lip Shield 55 mg/g; 40 mg/g 85599-0212-45 | CLEAN | 1 cylinder | — | — | FDA listed | — |
| Mineral Lip Sunscreen Tinted 55 mg/g; 40 mg/gthis 85634-0212-45 | DR. | 1 cylinder | — | — | FDA listed | — |
| Sheer Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85317-0212-45 | TRU | 4.5 g | — | — | FDA listed | — |
| Advanced Lip Guard 55 mg/g; 40 mg/g 85351-0212-45 | ADVANCED | 4.5 g | — | — | FDA listed | — |
| Sunshade Mineral Stick Sunscreen 55 mg/g; 40 mg/g 85730-0219-30 | BELLAGENA | 30 g | — | — | FDA listed | — |
| CoTZ Kids Mineral Sun Stick 55 mg/g; 40 mg/g 58892-0362-30 | Fallien | 1 cylinder | — | — | FDA listed | — |
| Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85581-0212-45 | Helen's | 1 cylinder | — | — | FDA listed | — |
| Tinted Lip Sunscreen 55 mg/g; 40 mg/g 85327-0212-45 | Rhonda | 1 cylinder | — | — | FDA listed | — |
| Lip Balm 55 mg/g; 40 mg/g 85649-0212-45 | PATRICIA | 1 cylinder | — | — | FDA listed | — |
| Lip Crack 55 mg/g; 40 mg/g 85730-0212-45 | BELLAGENA | 1 cylinder | — | — | FDA listed | — |
| Kind Restore Moisturizing Lip Balm 55 mg/g; 40 mg/g 85895-0212-45 | POLISH | 1 cylinder | — | — | FDA listed | — |
| Really Great Lip Shield 55 mg/g; 40 mg/g 85585-0212-45 | JEFFREY | 1 cylinder | — | — | FDA listed | — |
| Mineral Lip Protection 55 mg/g; 40 mg/g 85504-0212-45 | COLETTE | 1 cylinder | — | — | FDA listed | — |
| Mineral Stick Tinted 55 mg/g; 40 mg/g 85507-0220-30 | IT | 30 g | — | — | FDA listed | — |
| Mineral Lip Protection 55 mg/g; 40 mg/g 85563-0212-45 | CLEAR | 4.5 g | — | — | FDA listed | — |
| Tinted Lip Sunscreen 55 mg/g; 40 mg/g 85608-0212-45 | LA | 1 cylinder | — | — | FDA listed | — |
| Lip Protection 55 mg/g; 40 mg/g 85339-0212-45 | Teton | 1 cylinder | — | — | FDA listed | — |
| Mineral Stick Non-Tinted 55 mg/g; 40 mg/g 85507-0219-30 | IT | 30 g | — | — | FDA listed | — |
| Lip Protecting 55 mg/g; 40 mg/g 85531-0212-45 | JOHANNA'S | 4.5 g | — | — | FDA listed | — |
| Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85558-0212-45 | LOTUS | 1 cylinder | — | — | FDA listed | — |
| Tinted Lip Sunscreen 55 mg/g; 40 mg/g 85596-0212-45 | LAURA | 1 cylinder | — | — | FDA listed | — |
| Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85625-0212-45 | LUNDQUIST | 1 cylinder | — | — | FDA listed | — |
| Non-Tinted Sports Stick 55 mg/g; 40 mg/g 85679-0219-30 | HELTON | 30 g | — | — | FDA listed | — |
| Tinted Lip Shade Sunscreen 55 mg/g; 40 mg/g 85712-0212-45 | BLISS | 1 cylinder | — | — | FDA listed | — |
| Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85888-0212-45 | MILESTHETICS | 1 cylinder | — | — | FDA listed | — |
| Mineral Sunscreen Stick Non-Tinted 55 mg/g; 40 mg/g 87572-0219-30 | UNDRBUDR, | 30 g | — | — | FDA listed | — |
| Non Tinted Mineral Sunscreen Stick 55 mg/g; 40 mg/g 85374-0219-30 | BABYFACE | 30 g | — | — | FDA listed | — |
| Tinted Mineral Sunscreen Stick 55 mg/g; 40 mg/g 85414-0220-30 | Hirschman, | 30 g | — | — | FDA listed | — |
| Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85492-0212-14 | The | 1 cylinder | — | — | FDA listed | — |
| Tinted Mineral Sunscreen Stick 55 mg/g; 40 mg/g 85598-0220-30 | BASS | 30 g | — | — | FDA listed | — |
| Mineral Tinted Lip Sunscreen 55 mg/g; 40 mg/g 85620-0212-45 | JADEIA | 4.5 g | — | — | FDA listed | — |
| Non Tinted Mineral Sunscreen Stick 55 mg/g; 40 mg/g 85888-0219-30 | MILESTHETICS | 30 g | — | — | FDA listed | — |
| Mineral Sunscreen Stick - Tinted 55 mg/g; 40 mg/g 87572-0220-30 | UNDRBUDR, | 30 g | — | — | FDA listed | — |
| Mineral Based Sunscreen Stick Non-Tinted 55 mg/g; 40 mg/g 81679-0219-30 | KATHLEEN | 30 g | — | — | FDA listed | — |
| Sunscreen Plus Mineral Stick Tinted 55 mg/g; 40 mg/g 85329-0220-30 | Lily | 30 g | — | — | FDA listed | — |
| Sun Safe Lip Balm 55 mg/g; 40 mg/g 85628-0212-45 | REVIVE | 1 cylinder | — | — | FDA listed | — |
| Tinted Lip Protection 55 mg/g; 40 mg/g 85747-0212-45 | WECARE | 1 cylinder | — | — | FDA listed | — |
| Tinted Mineral Sunscreen Stick 55 mg/g; 40 mg/g 85888-0220-30 | MILESTHETICS | 30 g | — | — | FDA listed | — |
| Tinted Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85939-0212-45 | ORAIOS | 1 cylinder | — | — | FDA listed | — |
| PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreen 55 mg/g; 40 mg/g 58892-0212-45 | Fallien | 4.5 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
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 85634-0212-45 You're viewing this | 1 CYLINDER in 1 CARTON (85634-212-45) / 4.5 g in 1 CYLINDER | 2023-04-11 | Active |
🧭 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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Is this package still being marketed?
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Do I need a prescription for this product?
Where does this data come from?
📄 FDA label — Drug Facts FDA SPL
📄 FDA label ▾
No readable label sections were found for this product.