LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 CORAL UNIVERSEL OCTINOXATE, ZINC OXIDE 49 mg/g; 75 mg/g Stick
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
This is an over-the-counter lip balm stick marketed as a hydrating product with sun protection. The two active ingredients, zinc oxide and octinoxate, are mineral and chemical ultraviolet filters commonly used together in sunscreen products to help protect skin from UV radiation. The balm is formulated to be applied topically to the lips and is regulated as an OTC monograph drug, meaning it follows FDA's established safety and effectiveness rules for this category rather than being individually reviewed.
Patient education
Supplement & herbal interactions
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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 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 47143LT58A
A synthetic form of vitamin C that acts as an antioxidant. It prevents other ingredients in the medicine from breaking down or discoloring when exposed to air or light.
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UNII 2ZA36H0S2V
Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.
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UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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UNII N863NB338G
Benzyl benzoate is a liquid organic compound used as a solvent and preservative in medicines. It helps dissolve active ingredients and can extend shelf life by preventing microbial growth in liquid formulations.
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UNII 0C9AC7D6XU
A plant-derived fat from shea nut kernels that remains after soap-making. It acts as a moisturizer, emollient, and texture enhancer in topical formulations, helping soften skin and improve product spreadability.
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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 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.
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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 V2W71V8T0X
A silicone-based compound that mixes oil and water together. Used in formulations as an emulsifier to help blend ingredients and improve texture and stability of creams, lotions, and other topical products.
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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 H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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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 GGG6W25C63
A plant resin derived from croton lechleri trees, used as a binder and film-forming agent to help hold tablet ingredients together and create protective coatings on medicines.
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UNII 481744AI4O
A synthetic red dye used to color medicines and products. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII ECW0LZ41X8
A synthetic red dye used to color tablets and capsules. It helps make medicines visually distinctive so patients can easily identify their medication.
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UNII 609A3V1SUA
A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
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UNII 3V5U97P248
A synthetic organic compound used as a UV filter and stabilizer in medications. It helps protect the drug from light degradation and may improve shelf life in formulations exposed to sunlight.
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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 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 L837108USY
Geraniol is a natural fragrant compound found in plants like roses and lemons. It's used in medicines as a flavoring agent and to improve the taste or aroma of the product.
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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 L7HT8F1ZOD
A plant-based oil extracted from soybeans. It's used as an emulsifier and lubricant to help mix ingredients evenly and prevent sticking during tablet or capsule manufacturing.
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UNII WB5K9Y35Y9
A synthetic crosslinked polymer made by combining hexamethylene diisocyanate with trimethylol hexyllactone. It's used as a film-former and binder to help create protective coatings on tablets or capsules and improve product stability.
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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 XDD37N2GPR
A fat derived from coconut oil that has been chemically treated to make it more stable. It works as a binder and lubricant to help hold the medicine together and improve how it flows during manufacturing.
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UNII N6Z62H4CC9
A synthetic polymer derived from polycyclopentadiene that has been chemically treated to add hydrogen. It serves as a binder and film-forming agent to help hold tablet ingredients together and create protective coatings on medications.
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UNII 7D1YQ9Y5EZ
Hydrogenated polybutene is a thick, wax-like ingredient made by chemically processing petroleum. It acts as a binder and lubricant, helping hold tablet ingredients together and allowing pills to slide smoothly during manufacturing and packaging.
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UNII 1394NXB9L6
A plant-derived protein from soybeans that has been broken down into smaller pieces using enzymes. It acts as a binder and texture agent, helping hold ingredients together and improve the product's consistency and mouthfeel.
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UNII 8SQ0VA4YUR
A fragrance compound derived from natural sources, used to add pleasant scent to the medicine. It serves as a flavoring or aromatic agent to mask unpleasant tastes or improve the product's sensory appeal.
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UNII 8Y12O726LX
Irvingia gabonensis kernel butter is a natural fat extracted from African mango seeds. It's used in medicines as an emollient and binder to soften formulations and help hold ingredients together.
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UNII A8289P68Y2
Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
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UNII S4V5BS6GCX
A synthetic oily liquid used as an emollient and solvent in topical medications. It helps dissolve active ingredients and creates a smooth, spreadable texture on the skin.
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UNII 0RE8K4LNJS
Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
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UNII 949E3KBJ1I
Isopropyl titanium triisostearate is a titanium-based compound used in medicines as a glidant and anticaking agent. It helps powders and granules flow smoothly during manufacturing and prevents clumping in the finished product.
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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 1A281RJ859
A natural oil derived from luffa plant seeds, used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the formulation or improve how it feels on skin.
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UNII 2BF9E65L7I
A chemical compound combining menthol with lactic acid. It's used in medicines as a flavoring agent and to provide a cooling or soothing sensation on the skin or mouth.
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UNII 461N1O614Y
A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
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UNII 3K0J1S7QGC
A fragrant essential oil derived from geranium flowers, used as a flavoring and fragrance agent to improve the taste and aroma of medicines.
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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 UG00KM4WR7
A plastic polymer used as a container material and film coating. It helps protect the medicine from moisture and air exposure during storage and shipping.
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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 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 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 59Z907ZB69
A synthetic silicone polymer used as a glidant and anti-caking agent. It reduces friction between particles, helping powders and tablets flow smoothly during manufacturing and use.
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UNII 9DLQ4CIU6V
Proline is an amino acid used in pharmaceutical formulations as a bulking agent and stabilizer. It helps maintain product stability and can improve the texture or consistency of medicines, particularly in powders and freeze-dried products.
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UNII 8D08K3S51E
Propylene carbonate is a clear liquid solvent derived from propylene. It helps dissolve or suspend active ingredients in liquid medicines and can improve how well the product flows and mixes.
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UNII 6T47AS764T
Red 40 Lake is a synthetic colorant made by combining Red 40 dye with aluminum hydroxide. It's used to give tablets, capsules, and other medicines a red or pink color for identification and appearance.
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UNII 5ET1T25H82
A protein component derived from rice that serves as a binder and filler in medications. It helps hold tablet ingredients together and adds bulk to the formulation.
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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 EU2PSP0G0W
Silica dimethyl silylate is a silicon-based powder that acts as a glidant and anti-caking agent. It reduces friction between particles and helps powders flow smoothly during manufacturing and tablet compression.
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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 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 SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
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UNII OLX698AH5P
A clay mineral processed with a quaternary ammonium compound. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
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UNII R53Q4ZWC99
Terpineol is a fragrant alcohol derived from pine oil or other plant sources. It's used in medicines as a flavoring agent and to improve the taste or aroma of the product.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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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 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 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.
64 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 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 |
|---|---|---|---|---|---|---|
| Lbel Solutions Pro Hialuron Balm Balsamo Labial Hidratante 72H Fps 20 Hydrating Lip Balm 72H Spf 20 Cherry Glaze 49 mg/g; 75 mg/g 14141-0463-01 | BEL | 1 tube | — | — | FDA listed | — |
| Lbel Solutions Pro Hialuron Balm Balsamo Labial Hidratante 72H Fps 20 Hydrating Lip Balm 72H Spf 20 Nude Universel 49 mg/g; 75 mg/g 14141-0352-01 | BEL | 1 tube | — | — | FDA listed | — |
| Lbel Solutions Pro Hialuron Balm Balsamo Labial Hidratante 72H Fps 20 Hydrating Lip Balm 72H Spf 20 Coral Universel 49 mg/g; 75 mg/gthis 14141-0351-01 | BEL | 1 tube | — | — | FDA listed | — |
| Lbel Solutions Pro Hialuron Balm Balsamo Labial Hidratante 72H Fps 20 Hydrating Lip Balm 72H Spf 20 Rose Creme 49 mg/g; 75 mg/g 14141-0464-01 | BEL | 1 tube | — | — | FDA listed | — |
| Lbel Solutions Pro Hialuron Balm Balsamo Labial Hidratante 72H Fps 20 Hydrating Lip Balm 72H Spf 20 Rose Universel 49 mg/g; 75 mg/g 14141-0353-01 | BEL | 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 |
|---|---|---|---|
| 14141-0351-01 You're viewing this | 1 TUBE in 1 BOX (14141-351-01) / 2 g in 1 TUBE | 2024-10-30 | 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?
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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.
⏱️ Dosage and Administration ▾
Directions Apply liberally and evenly 15 minutes before sun exposure Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor.
⚠️ Warnings ▾
Warnings Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. 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 swallowed, get medical help or contact a Poison Control Center right away.
🧪 Active Ingredient ▾
Active ingredients Octinoxate 7.50% Zinc Oxide 4.90%
🧪 Inactive Ingredients ▾
Inactive Ingredients Isononyl isononanoate, hydrogenated polycyclopentadiene, hydrogenated polyisobutene, polyethylene, glycerin, beeswax, butyrospermum parkii (shea) butter extract, isododecane, silica, polyglyceryl-3 diisostearate, simmondsia chinensis (jojoba) seed oil, octyldodecanol, dicaprylyl carbonate, butyrospermum parkii (shea) butter, diethylhexyl syringylidenemalonate, copernicia cerifera (carnauba) wax, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, disteardimonium hectorite, tocopheryl acetate, polymethylsilsesquioxane, menthyl lactate, hexyl laurate, irvingia gabonensis kernel butter, ethylhexyl palmitate, fragrance, glycine soja (soybean) seed extract, hdi/trimethylol hexyllactone crosspolymer, silica dimethyl silylate, butyrospermum parkii (shea) butter unsaponifiables, hydrogenated coco-glycerides, phenoxyethanol, sorbitol/sebacic acid copolymer behenate, argania spinosa kernel oil, sodium hyaluronate, caprylic/capric triglyceride, caprylyl glycol, sodium saccharin, triethoxycaprylylsilane, chlorphenesin, croton lechleri resin extract, luffa cylindrica seed oil, tocopherol, ascorbyl tetraisopalmitate, water, hydrolyzed soy protein, rice amino acids, proline, hydrolyzed adansonia digitata seed extract, geraniol, terpineol, hydroxycitronellal, benzyl alcohol, benzyl benzoate, pelargonium graveolens flower oil.
May contain : Red 40 lake, red 6 lake, red 7 lake, iron oxides, titanium dioxide, isopropyl myristate, blue 1 lake, isopropyl titanium triisostearate, stearalkonium hectorite, polyhydroxystearic acid, propylene carbonate.
🎯 Purpose ▾
Purpose Sunscreen