ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene 50 mg/mL; 30 mg/mL; 100 mg/mL; 68 mg/mL Lotion — NDC 42851-0096-20 package photo

ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene 50 mg/mL; 30 mg/mL; 100 mg/mL; 68 mg/mL Lotion

by ZO Skin Health, Inc. · 1 TUBE in 1 CARTON (42851-096-20) / 45 mL in 1 TUBE
NDC 42851-0096-20
🏷️ FDA NDC (as labeled) 42851-096-20 billing pads the product segment with a zero
This package
Contains45 mL in 1 tube Pack sizes2 compare ↓
Also comes in: 45 mL 42851-0096-45
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 →

🆔 Identity & classification

FDA NDC (as labeled) 42851-096-20
Product NDC 42851-096
11-digit billing NDC 42851009620
UNII 4X49Y0596W, G63QQF2NOX, 5A68WGF6WM, V06SV4M95S
Application # M020
SPL Set ID 1560a6b6-8d4a-6942-e063-6294a90a4a44
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-04-19
Route TOPICAL
Dosage form LOTION
Substance OCTISALATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE
Why two NDCs? The FDA registers this code as 42851-096-20 — 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 → 42851-0096-20. 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

LabelerZO Skin Health, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code42851
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio23 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?

ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 is a topical lotion that contains four active sunscreen ingredients: avobenzone, homosalate, octisalate, and octocrylene. These ingredients function as ultraviolet (UV) filters, working together to absorb and scatter UVA and UVB rays from the sun. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established safety and effectiveness standards for sunscreen products in this category.

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 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.
  • UNII TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII GEV2EL4D9G
    A synthetic polymer made from acrylic compounds that form a network structure. It works as a thickener and gelling agent in topical products to create the right texture and consistency.
  • 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.
  • 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.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • 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.
  • 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 3J2P07GVB6
    Cellulose acetate is a plant-derived polymer made by chemically modifying cellulose fibers. In medications, it serves as a film-coating material for tablets and capsules to protect the drug, control release, and improve appearance.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII ICS790225B
    A plant-derived cleaning agent made from coconut oil and glucose. It works as a surfactant and emulsifier to help mix oil and water-based ingredients together in the formulation.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII T3064TZ75A
    A silicone-based polymer mixture used as an anti-foaming agent and skin protectant in topical formulations. It helps reduce surface bubbles during manufacturing and creates a smooth, water-resistant barrier on the skin.
  • UNII 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 5B8915UELW
    A plant-derived compound used as an antioxidant in medicines. It helps prevent spoilage and degradation of active ingredients during storage by protecting them from oxidative damage.
  • UNII MJ2YTT4J8M
    Ethyl linoleate is a fatty acid ester derived from linoleic acid. It acts as an emollient and solvent in formulations, helping to dissolve or carry active ingredients and improve product texture and absorption.
  • UNII 9A87HC7ROD
    A synthetic compound used as a plasticizer and conditioning agent in tablet coatings and film formulations. It helps make coatings flexible and improves how they cling to the tablet surface.
  • 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.
  • 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 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 KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII O0CV1RMR44
    A dark pigment made synthetically from tyrosine and peroxide. It's used as a colorant in tablets and capsules to give medicines their color and help distinguish different dosages visually.
  • 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 172F2WN8DV
    A fatty alcohol derived from animal or plant oils. It acts as an emollient and helps stabilize emulsions, allowing oil and water to mix evenly in the medication.
  • UNII 1206E8961B
    A synthetic moisturizing compound derived from panthenol. It's used in topical formulations as an emollient and skin conditioner to help soften and hydrate the skin surface.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII 762O8IWA10
    PEG-8 laurate is a synthetic compound made by combining polyethylene glycol with lauric acid. It acts as an emulsifier and solubilizer in medicines, helping to blend water and oil-based ingredients together and improve how well some drugs dissolve.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • UNII 6F650HF10T
    A plant extract from Japanese butterbur root used as a natural flavoring agent or botanical ingredient in some formulations to add taste and plant-derived components to the medicine.
  • 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 Z47NNT4J11
    A synthetic plastic polymer used as a film-coating material on tablets and capsules. It helps protect the medicine, control how fast it dissolves, and improve appearance by creating a smooth, glossy outer layer.
  • UNII UEM62QMW5F
    Polyamide-5 is a synthetic plastic polymer used in pharmaceuticals as a coating or film-forming agent. It helps protect the medicine and control how quickly the drug releases in the body.
  • 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.
  • UNII MZM1I680W0
    Propylene glycol stearate is a waxy substance made by combining stearic acid with propylene glycol. It acts as an emulsifier to help blend oil and water ingredients, and also serves as a thickener or stabilizer in the medicine.
  • UNII IJ67X351P9
    A natural plant extract from rosemary leaves used as a preservative to help prevent oils and fats in the medicine from spoiling or becoming rancid during storage.
  • 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.
  • UNII V56DFE46J5
    Steareth-2 is a synthetic emulsifier made from stearic acid and ethylene oxide. It helps mix oil and water-based ingredients together in the formulation and may improve how the medicine spreads or dissolves.
  • UNII 53J3F32P58
    A synthetic detergent derived from stearic acid, a fatty substance. It helps dissolve or distribute oil-based ingredients evenly throughout the medicine, acting as an emulsifier and solubilizer in tablets and capsules.
  • 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.
  • 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.
  • 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 1D1K0N0VVC
    A fat-soluble form of vitamin A used as a colorant and nutritional fortification ingredient. It gives products a yellow or orange tint and increases vitamin A content in the formula.
  • 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.

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

The official label also statesWater, Dimethicone, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Mica, Polyamide-5, Steareth-21, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Petasites Japonicus Root Extract, Tocopheryl Acetate, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Caprylyl Glycol, Hexylene Glycol, Propylene Glycol Stearate, Melanin, Pentylene Glycol, Tetrahexyldecyl Ascorbate, Beta-Glucan, Glycerin, Ethyl Linoleate, Oleyl Alcohol, Acrylates Crosspolymer-4, Dimethicone/Vinyl Dimethicone Crosspolymer, Magnesium Stearate, Panthenyl Triacetate, Cetearyl Alcohol, PEG-8 Laurate, Coco-Glucoside, Steareth-2, Polymethyl Methacrylate, Cellulose Acetate,Acrylates/Ammonium Methacrylate Copolymer, Simethicone, Disodium EDTA, Sodium Hydroxide, Ethyl Ferulate, Phenoxyethanol, 1,2-Hexanediol, Potassium Sorbate, Ethylhexylglycerin, Ethylene Brassylate, Fragrance, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, 77492, 77499).

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 DailyMedingredient 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 gPer 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.
Try another pack size: 45 mL
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
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 50 mg/mL; 30 mg/mL; 100 mg/mL; 68 mg/mLthis 42851-0096-20 ZO 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
Apr 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 Avobenzone, Homosalate, Octisalate, Octocrylene — the ingredient across all brands.

Top reported reactions

Rash40
Skin Cancer39
Pruritus31
Erythema26
Pain26
Dyspnoea25
Fatigue25

Age at onset

Infant1
Child6
Adolescent4
Adult61
Elderly45

Reporter sex

650 reports
Male · 36%
Female · 64%

Serious outcomes

Hospitalization99
Disabling23
Death23
Life-threatening11
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 159 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
42851-0096-20 You're viewing this 1 TUBE in 1 CARTON (42851-096-20) / 45 mL in 1 TUBE 2024-04-19 Active
42851-0096-45 1 TUBE in 1 CARTON (42851-096-45) / 45 mL in 1 TUBE 2024-04-19 Active

Pack size FAQ

What quantity is in NDC 42851-0096-20?
NDC 42851-0096-20 is listed by the FDA — 1 tube in 1 carton / 45 ml in 1 tube.
What NDC number is used to bill for this package of ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene 50 mg/mL; 30 mg/mL; 100 mg/mL; 68 mg/mL Lotion?
Bill NDC 42851-0096-20 — the 11-digit billing format is 42851009620. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 42851-096-20, 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: 42851-0096-20, written without dashes as 42851009620. 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 42851-0096-20, the first segment (42851) is the labeler code FDA assigned to ZO Skin Health, Inc.; the middle segment (0096) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) 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 ZO Skin Health, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (42851-0096-45). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
ZO Skin Health, Inc. 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 96 words

Directions Apply liberally 15 minutes before sun exposure and as needed. Use a water-resistant sunscreen if swimming or sweating. Reapply: ■ at least every 2 hours ■ Children under 6 months of age: Ask a doctor.

Sun Protection 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.

⏱️ Dosage and Administration ~2 min read

Drug Facts Active Ingredients Ingredients Purpose Avobenzone 3.0%............. Sunscreen Homosalate 6.8%............. Sunscreen Octisalate 5.0%................

Sunscreen Octocrylene 10.0%................ Sunscreen Uses helps prevent sunburn higher SPF gives more sunburn protection provides high protection against 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 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 swallowed, get medical help or contact a Poison Control Center right away. Directions Apply liberally 15 minutes before sun exposure and as needed.

Use a water-resistant sunscreen if swimming or sweating. Reapply: ■ at least every 2 hours ■ Children under 6 months of age: Ask a doctor. Sun Protection 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. Other Information Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Protect this product from excessive heat and direct sun. Inactive Ingredients Water, Dimethicone, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Mica, Polyamide-5, Steareth-21, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Petasites Japonicus Root Extract, Tocopheryl Acetate, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Caprylyl Glycol, Hexylene Glycol, Propylene Glycol Stearate, Melanin, Pentylene Glycol, Tetrahexyldecyl Ascorbate, Beta-Glucan, Glycerin, Ethyl Linoleate, Oleyl Alcohol, Acrylates Crosspolymer-4, Dimethicone/Vinyl Dimethicone Crosspolymer, Magnesium Stearate, Panthenyl Triacetate, Cetearyl Alcohol, PEG-8 Laurate, Coco-Glucoside, Steareth-2, Polymethyl Methacrylate, Cellulose Acetate,Acrylates/Ammonium Methacrylate Copolymer, Simethicone, Disodium EDTA, Sodium Hydroxide, Ethyl Ferulate, Phenoxyethanol, 1,2-Hexanediol, Potassium Sorbate, Ethylhexylglycerin, Ethylene Brassylate, Fragrance, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, 77492, 77499).

⚠️ Warnings 54 words

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 swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 38 words

Other Information Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. Protect this product from excessive heat and direct sun.

🧪 Active Ingredient 16 words

Active Ingredients Ingredients Purpose Avobenzone 3.0%............. Sunscreen Homosalate 6.8%............. Sunscreen Octisalate 5.0%................ Sunscreen Octocrylene 10.0%................ Sunscreen

🧪 Inactive Ingredients 108 words

Inactive Ingredients Water, Dimethicone, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Mica, Polyamide-5, Steareth-21, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Petasites Japonicus Root Extract, Tocopheryl Acetate, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Caprylyl Glycol, Hexylene Glycol, Propylene Glycol Stearate, Melanin, Pentylene Glycol, Tetrahexyldecyl Ascorbate, Beta-Glucan, Glycerin, Ethyl Linoleate, Oleyl Alcohol, Acrylates Crosspolymer-4, Dimethicone/Vinyl Dimethicone Crosspolymer, Magnesium Stearate, Panthenyl Triacetate, Cetearyl Alcohol, PEG-8 Laurate, Coco-Glucoside, Steareth-2, Polymethyl Methacrylate, Cellulose Acetate,Acrylates/Ammonium Methacrylate Copolymer, Simethicone, Disodium EDTA, Sodium Hydroxide, Ethyl Ferulate, Phenoxyethanol, 1,2-Hexanediol, Potassium Sorbate, Ethylhexylglycerin, Ethylene Brassylate, Fragrance, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, 77492, 77499).

🎯 Purpose 41 words

Uses helps prevent sunburn higher SPF gives more sunburn protection provides high protection against 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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.