Home › NDC Lookup › Ingredients › Octinoxate, Zinc Oxide › 14141-0349-01
CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CHERRY CREAMY OCTINOXATE, ZINC OXIDE 39.2 mg/g; 25 mg/g Stick — NDC 14141-0349-01 package photo

CYZONE CY PLAY CREAMY LIP BALM HIDRATANTE EN BARRA PARA LABIOS 24H FPS 12 CHERRY CREAMY OCTINOXATE, ZINC OXIDE 39.2 mg/g; 25 mg/g Stick

by BEL STAR S A · 1 TUBE in 1 CARTON (14141-349-01) / 3 g in 1 TUBE
NDC 14141-0349-01
🏷️ FDA NDC (as labeled) 14141-349-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 14141-349-01
Product NDC 14141-349
11-digit billing NDC 14141034901
UNII 4Y5P7MUD51, SOI2LOH54Z
Application # M020
SPL Set ID ea39a1c0-6b12-77ba-e053-2995a90a7314
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-12
Route TOPICAL
Dosage form STICK
Substance ZINC OXIDE; OCTINOXATE
Why two NDCs? The FDA registers this code as 14141-349-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 14141-0349-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerBEL STAR S A
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code14141
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio70 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is a lip balm stick applied topically to the lips, marketed as an OTC monograph product under FDA rules for sunscreen category products. It contains zinc oxide and octinoxate, which are mineral and chemical ultraviolet (UV) filters commonly used in sunscreen products to help protect skin from sun exposure. The product is formulated with a creamy texture and labeled as providing 24-hour hydration with SPF 12 protection.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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.

  • UNII P01OUT964K
    A fragrant plant-derived alcohol used as a flavoring agent and fragrance component in medicines. It provides taste and aroma to make the product more pleasant to use.
  • UNII 9ACA4K9013
    Apple seed oil is a plant-derived oil extracted from apple seeds. It's used in medicines as an emollient and conditioning agent to help soften and smooth the product's texture or delivery.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • UNII 8470G57WFM
    Corn oil is a vegetable oil extracted from corn kernels. It's used in medicines as a solvent to dissolve active ingredients and help the body absorb them, and sometimes as a lubricant in capsules.
  • UNII 73KDS3BW5E
    A plant oil extracted from cranberry seeds, used in medications as an emollient and emulsifier. It helps blend oil and water-based ingredients together and keeps the product's texture smooth and stable.
  • UNII 2M7H5Y5MJP
    A synthetic red colorant made by combining D&C Red No. 21 dye with aluminum salts. It's used to give tablets, capsules, or other medicines their red color and help identify the product.
  • UNII 2LRS185U6K
    D&C Red No. 27 is a synthetic red colorant used in medicines and cosmetics. It gives tablets, capsules, or liquids their red or reddish color so products are visually identifiable.
  • UNII 2S42T2808B
    A synthetic red dye used as a colorant to give the medicine its red color. It helps make pills or liquids visually distinct and easier to identify.
  • 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.
  • UNII 554N82UWVW
    A synthetic oily substance made from dipentaerythritol combined with caprylic and capric acids. It functions as an emollient and skin-conditioning agent in topical formulations, helping to soften and smooth the product texture.
  • 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.
  • UNII J9EQA3S2JM
    FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • 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.
  • 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.
  • 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.
  • 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.
  • UNII O82C39RR8C
    A tart citrus fruit extract used as a natural flavor and aroma ingredient in medications. It enhances taste and may help mask bitter drug flavors in liquid formulations.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • UNII YK3DC63Y5M
    A mineral compound derived from natural or synthetic sources that acts as an anti-caking agent and flow aid. It helps prevent clumping and improves the powder's ability to flow smoothly during manufacturing and tablet formation.
  • UNII V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • UNII VLW429K27K
    A synthetic oily liquid made from neopentyl glycol and medium-chain fatty acids. Used in medicines as an emollient and solubilizer to help dissolve active ingredients and improve how the body absorbs them.
  • 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.
  • UNII XO45V955LT
    A natural oil extract from olives that contains compounds resistant to saponification. Used as an emollient and skin-conditioning agent to improve product texture and spreadability in topical formulations.
  • 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.
  • 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.
  • 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.
  • UNII 0UI45XV0T6
    A plant oil extracted from pomegranate seeds. It's used in formulations as an emollient to soften and smooth the product texture, and sometimes as a carrier or conditioning agent in topical preparations.
  • UNII R60QEP13IC
    Rice bran is a natural powder made from the outer layer of rice grains. It's used in medicines as a filler and flow agent to add bulk and help the product mix and flow smoothly during manufacturing.
  • UNII LZO6K1506A
    Rice bran oil is a natural oil extracted from rice grain. It's used in medicines as an emollient and solvent to help dissolve or suspend active ingredients and improve how the medicine feels when applied or taken.
  • 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.
  • UNII XUK1106UBO
    A natural resin derived from the sal tree, used as a binder and film-former in tablets and capsules to help hold ingredients together and create protective coatings.
  • UNII 9X3RP3RJFH
    A natural oil extracted from sweet cherry seeds. It's used in medicines as a solvent and to improve how the product feels or spreads on the skin.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.
  • 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.
  • UNII 684PA7HRMI
    A natural wax derived from the fruit of the Toxicodendron succedaneum tree. It functions as a coating and glazing agent in medicines to provide a protective barrier and smooth finish to tablets or capsules.
  • UNII 6RG2461FCH
    A natural plant-based wax derived from the fruit rind of Toxicodendron vernicifluum (Chinese lacquer tree). Used as a coating agent and lubricant to provide a smooth surface on tablets or capsules and improve handling during manufacturing.
  • UNII A8OE252M6L
    A synthetic fatty substance made from plant or mineral oils. It works as a lubricant and emollient in medicines, helping pills slide smoothly during manufacturing and improving how the product feels or spreads.
  • UNII FY36J270ES
    A synthetic chemical compound used as a plasticizer in film coatings. It makes tablet or capsule coatings flexible and durable so they don't crack or break during handling and storage.
  • 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.
  • 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.

53 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesOctyldodecanol, ricinus communis (castor) seed oil, butyrospermum parkii (shea) butter, polyethylene, helianthus annuus (sunflower) seed wax, copernicia cerifera (carnauba) wax, glycerin, dipentaerythrityl hexacaprylate/hexacaprate, vegetable oil, oryza sativa (rice) bran oil, tridecyl trimellitate, olea europaea (olive) oil unsaponifiables, phytosteryl/behenyl/octyldodecyl lauroyl glutamate, oryza sativa (rice) bran wax, rhus succedanea fruit wax, fragrance, tridecyl stearate, disteardimonium hectorite, rhus verniciflua peel wax, shorea robusta resin, neopentyl glycol dicaprylate/dicaprate, phenoxyethanol, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, lauroyl lysine, hexyl laurate, punica granatum seed oil, prunus avium (sweet cherry) seed oil, pyrus malus (apple) seed oil, vaccinium macrocarpon (cranberry) seed oil, triethoxycaprylylsilane, caprylyl glycol, lecithin, chlorphenesin, water, citrus paradisi (grapefruit) fruit extract, ascorbyl palmitate, tocopherol, citronellol. May contain: Mica, titanium dioxide, iron oxides, synthetic fluorphlogopite, red 30 lake, red 7 lake, red 40 lake, talc, red 27 lake, yellow 5 lake, hydrogenated polyisobutene, blue 1 lake, red 21 lake, palmitic acid.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eachPer 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cyzone Cy Play Creamy Lip Balm Hidratante En Barra Para Labios 24H Fps 12 Nude Creamy 39.2 mg/g; 25 mg/g 14141-0308-01 BEL 1 tube — — FDA listed —
Cyzone Cy Play Creamy Lip Balm Hidratante En Barra Para Labios 24H Fps 12 Pink Creamy 39.2 mg/g; 25 mg/g 14141-0307-01 BEL 1 tube — — FDA listed —
Cyzone Cy Play Creamy Lip Balm Hidratante En Barra Para Labios 24H Fps 12 Berry Creamy 39.2 mg/g; 25 mg/g 14141-0348-01 BEL 1 tube — — FDA listed —
Cyzone Cy Play Creamy Lip Balm Hidratante En Barra Para Labios 24H Fps 12 Cherry Creamy 39.2 mg/g; 25 mg/gthis 14141-0349-01 BEL 1 tube — — FDA listed —
Cyzone Cy Play Creamy Lip Balm Hidratante En Barra Para Labios 24H Fps 12 Coral Creamy 39.2 mg/g; 25 mg/g 14141-0309-01 BEL 1 tube — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for OCTINOXATE, ZINC OXIDE — the ingredient across all brands.

Top reported reactions

Application Site Erythema2
Application Site Swelling2
Pruritus2
Skin Exfoliation2
Urticaria2
Anaphylactic Shock1
Application Site Burn1

Age at onset

Adult1

Reporter sex

8 reports
Female · 100%

Serious outcomes

Hospitalization1
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 3 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
14141-0349-01 You're viewing this 1 TUBE in 1 CARTON (14141-349-01) / 3 g in 1 TUBE 2024-09-12 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 14141-349-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 14141-0349-01, written without dashes as 14141034901. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 14141-0349-01, the first segment (14141) is the labeler code FDA assigned to BEL STAR S A; the middle segment (0349) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by BEL STAR S A. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
BEL STAR S A is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 4 words ▾

Uses Helps prevent sunburn.

⏱️ Dosage and Administration 34 words ▾

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 93 words ▾

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 7 words ▾

Active Ingredients Octinoxate 2.50% Zinc Oxide 3.92%

🧪 Inactive Ingredients 146 words ▾

Inactive Ingredients Octyldodecanol, ricinus communis (castor) seed oil, butyrospermum parkii (shea) butter, polyethylene, helianthus annuus (sunflower) seed wax, copernicia cerifera (carnauba) wax, glycerin, dipentaerythrityl hexacaprylate/hexacaprate, vegetable oil, oryza sativa (rice) bran oil, tridecyl trimellitate, olea europaea (olive) oil unsaponifiables, phytosteryl/behenyl/octyldodecyl lauroyl glutamate, oryza sativa (rice) bran wax, rhus succedanea fruit wax, fragrance, tridecyl stearate, disteardimonium hectorite, rhus verniciflua peel wax, shorea robusta resin, neopentyl glycol dicaprylate/dicaprate, phenoxyethanol, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, lauroyl lysine, hexyl laurate, punica granatum seed oil, prunus avium (sweet cherry) seed oil, pyrus malus (apple) seed oil, vaccinium macrocarpon (cranberry) seed oil, triethoxycaprylylsilane, caprylyl glycol, lecithin, chlorphenesin, water, citrus paradisi (grapefruit) fruit extract, ascorbyl palmitate, tocopherol, citronellol.

May contain: Mica, titanium dioxide, iron oxides, synthetic fluorphlogopite, red 30 lake, red 7 lake, red 40 lake, talc, red 27 lake, yellow 5 lake, hydrogenated polyisobutene, blue 1 lake, red 21 lake, palmitic acid.

🎯 Purpose 2 words ▾

Purpose Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 14141-0348-01 · BEL 14141-0350-01 · BEL →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.