OS-01 Lip SPF BS SPF15 Zinc Oxide 5.5 g/100g 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 an over-the-counter sunscreen cream applied to the lips, marketed under FDA's sunscreen rule for nonprescription products. The active ingredient is zinc oxide, a mineral sun filter that typically works by reflecting and scattering ultraviolet light away from the skin. This product is commonly used to help protect lip skin from sun damage. The formulation includes SPF 15, indicating its sun protection strength rating.
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.
🧪 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 LY001N554L
A hydrocarbon gas used as a propellant in pressurized aerosol formulations. It helps dispense the medication evenly when you activate the inhaler or spray.
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UNII S347WMO6M4
Beta-sitosterol is a plant-derived sterol (waxy substance from vegetable oils and seeds). In medicines, it acts as an emulsifier or thickening agent to help blend oil and water-based ingredients and improve texture.
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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.
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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 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 E00JL9G9K0
A plant-derived cleaning agent made from coconut oil and natural sugars. It works as a solubilizer and emulsifier to help mix water and oil-based ingredients together in the medicine.
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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.
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UNII 4YS74Q4G4J
A plant extract from Centella asiatica containing natural compounds called triterpenoids. It's used as an active ingredient in some formulations for its purported skin-supporting properties, though it functions as a botanical additive rather than a structural component of the medicine.
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UNII E6AHA53N1H
A synthetic amino acid derivative used as a skin-conditioning agent and emollient in topical formulations. It helps soften and smooth the product's texture while improving how it spreads on skin.
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UNII 7GXZ3858RY
Ectoine is a naturally derived protective compound used in pharmaceuticals as a stabilizer and humectant. It helps preserve the integrity of active ingredients and maintain moisture in formulations.
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UNII 91GW059KN7
Ethylene is a simple gas derived from petroleum. In medicines, it may be used as a propellant in aerosol inhalers or sprays to help deliver the active drug to the lungs or skin.
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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 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.
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UNII US2H3D7800
Garcinia indica seed butter is a natural fat extracted from the seeds of the kokum tree. It's used in medicines as a binder and lubricant to help hold ingredients together and improve how the tablet or capsule flows during manufacturing.
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UNII 36W3E5TAMG
Glucomannan is a natural soluble fiber derived from the konjac plant. In medications, it acts as a binder and bulking agent, helping hold ingredients together and add volume to 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 Z3MP1W91CW
A fatty substance derived from glycerin and oleic acid. It acts as an emulsifier to help blend oil and water-based ingredients, and may serve as a lubricant or thickening agent in the formulation.
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UNII 4PC054V79P
A fatty acid derived from glycerin and oleic acid (a natural oil component). It acts as an emulsifier to help mix oil and water-based ingredients, and serves as a lubricant and surfactant in the formulation.
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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 T53SBG6741
A plant-based oil extracted from sea buckthorn seeds. It's used as an emollient and skin-conditioning agent to soften the medicine's texture and improve how it feels or spreads on skin.
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UNII X33R8U0062
Isostearic acid is a fatty acid derived from vegetable oils. It acts as an emulsifier and lubricant in medicines, helping blend ingredients together and reducing friction during tablet or capsule manufacturing.
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UNII 33X04XA5AT
Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
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UNII 834K0WOS5G
A natural fat extracted from sunflower seeds. It acts as an emulsifier and lubricant in medicines, helping mix ingredients that don't normally blend together and allowing the product to flow smoothly during manufacturing.
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UNII 2UMI9U37CP
Oleic acid is a naturally occurring fatty acid derived from plant or animal oils. It functions as an emulsifier and solvent in medicines, helping blend water and oil-based ingredients together and dissolving other components.
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UNII 2V16EO95H1
Palmitic acid is a saturated fatty acid derived from plant and animal sources. It serves as an emulsifier and lubricant in medicines, helping ingredients mix smoothly and preventing sticking during manufacturing.
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UNII RV743D216M
A synthetic peptide derived from fatty acids and amino acids. It functions as a skin-conditioning agent and emollient in topical formulations, helping soften and smooth the product texture while supporting skin hydration.
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UNII 255PIF62MS
A synthetic antioxidant compound used to prevent oils and fats in medications from breaking down or becoming rancid during storage. It helps maintain the medicine's stability and shelf life.
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UNII 7Q0OK5DOT4
A plant-derived emulsifier made from glycerin and ricinoleic acid (from castor oil). It helps blend oil and water-based ingredients together in formulations and improves product texture and stability.
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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 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 AUG1H506LY
Propylene is a simple hydrocarbon gas used in medicines as a solvent and carrier. It helps dissolve or suspend active ingredients and improves how the medicine flows and mixes during manufacturing.
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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 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.
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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 7QWM220FJH
Squalene is a natural oil-like substance found in shark liver and some plants. It's used in medicines as an emulsifier to help mix oil and water-based ingredients together.
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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 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 8OC9U7TQZ0
Tribehenin is a waxy, plant-derived substance that acts as a lubricant and glidant in tablets and capsules. It helps the medicine flow smoothly during manufacturing and prevents sticking during production and packaging.
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UNII 06YD7896S3
A waxy, fatty substance derived from stearic acid. It acts as a thickener and texture modifier in medicines, helping control how quickly the drug dissolves and improving the product's firmness and consistency.
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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.
41 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 |
|---|---|---|---|---|---|---|
| OS-01 Lip SPF BS SPF15 5.5 g/100g 84451-0004-02 | ONESKIN | 1 tube | — | — | FDA listed | — |
| Pure velocity MINERAL SUNSCREEN SPF 50 5.5 g/100g 60771-0033-01 | Guangzhou | 50 g | — | — | FDA listed | — |
| OS-01 Lip SPF BS SPF15 5.5 g/100gthis 62742-4270-02 | Allure | 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?
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 62742-4270-02 You're viewing this | 1 TUBE in 1 CARTON (62742-4270-2) / 12 g in 1 TUBE (62742-4270-1) | 2025-05-07 | 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?
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?
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: • Apply liberally 15 minutes before sun exposure. • Reapply at least every 2 hours • Use a water-resistant sunscreen If swimming or sweating. • Children under 8 months of age: Ask a Doctor. • Sun Probation 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
⚠️ Warnings ▾
Warnings For external use only
🧪 Active Ingredient ▾
Active ingredie: Zinc Oxide 5.5%.
🧪 Inactive Ingredients ▾
Inactive Ingredients Simmondsia Chinensis (Jojoba) Seed Oil, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl Palmitate, Butyl octyl Salicylate. Caprylic/Capric Triglyceride, Water (Aqua), Garcinia Indica Seed Butter, Tocopheryl Acetate, Butylene/Ethylene/Styrene Copolymer, Glyceryl Oleate, Glyceryl Dioleate, Glycerin, Oleic Acid, Tribehenin, Sorbitan Isostearate, Palmitoyl Tripeptide-1, Dipalmitoyl Hydroxyproline, Trihydroxystearin, Sodium Hyaluronate, Glucomannan, Tetrahexyldecyl Ascorbate, Bisabolol, Decapeptide-52*,Ethylhexylglycerin, Caprylyl/Capryl Glucoside, Propanediol, Ectoin, Centella Asiatica Extract, Hippophae Rhamnoides oil, Helianthus Annuus (Sunflower) Seed Oil, Copernicia Cerifera (Carnauba)Wax, Tocopherol, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Polyhydroxy stearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Beta-Sitosterol, Squalene, Lactic Acid, Palmitic acid.
🎯 Purpose ▾
Purpose: Sunscreen