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(from DailyMed)

Coppertone Every Tone Brightening Sunscreen SPF 60 Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10% 5 g/100g; 10 g/100g; 3 g/100g; 15 g/100g Lotion

by Beiersdorf Inc · 1 BOTTLE, PUMP in 1 CARTON (66800-8000-1) / 50 g in 1 BOTTLE, PUMP
NDC 66800-8000-01
🏷️ FDA NDC (as labeled) 66800-8000-1 billing pads the package 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 →

🆔 Identity & classification

FDA NDC (as labeled) 66800-8000-1
Product NDC 66800-8000
11-digit billing NDC 66800800001
UNII 4X49Y0596W, 5A68WGF6WM, G63QQF2NOX, V06SV4M95S
UPC 0072140039929
Application # M020
SPL Set ID 23e368db-4b2f-d23b-e063-6394a90a1f06
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-10-15
Route TOPICAL
Dosage form LOTION
Substance OCTISALATE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE
Why two NDCs? The FDA registers this code as 66800-8000-1 — a 5-4-1 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 package segment → 66800-8000-01. 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

LabelerBeiersdorf Inc
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code66800
First marketedOct 2024
Product typeHuman Otc Drug
Portfolio105 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 topical lotion sunscreen marketed under the FDA's over-the-counter monograph rules. It contains four UV-filtering agents (avobenzone, homosalate, octisalate, and octocrylene) that are commonly used together in sunscreen formulations to help absorb and scatter ultraviolet radiation from the sun. The product is labeled with an SPF 60 rating, which indicates the level of UVB protection the combination of filters is intended to provide. This lotion is applied directly to the skin as a sun-protective product.

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 933ANU3H2S
    12-Hydroxystearic acid is a fatty acid derived from plant or animal oils. It works as a thickener and emulsifier in medicines, helping blend ingredients together and give the product a smooth, stable texture.
  • UNII 2IK4UQ3ZGA
    A synthetic chemical compound used in topical formulations as an antioxidant and stabilizer. It helps prevent degradation of active ingredients and maintains product consistency during storage.
  • UNII 8Z5ZAL5H3V
    A synthetic polymer made from acrylate compounds. It acts as a thickener and stabilizer in topical formulations, helping create the right texture and prevent separation of ingredients.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 75D21FL1PI
    A synthetic liquid derived from butylene glycol and fatty acids. It acts as an emollient and solvent to help dissolve or suspend active ingredients, improving texture and absorption in topical or oral formulations.
  • 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 Y15I6XI14C
    An oily liquid derived from petroleum, C12-20 alkyl benzoate serves as a solvent and emollient in medicines. It helps dissolve other ingredients and gives the product a smooth, spreadable texture.
  • UNII S4255P4G5M
    Calcium silicate is a white powder made from calcium and silicon compounds. It acts as an anti-caking agent and flow aid, helping powder ingredients move smoothly during tablet or capsule manufacturing.
  • UNII GSA2TXZ34G
    A synthetic polymer made from castor oil and a chemical linker, used as a coating or binder in medications to control how and when the active ingredient is released in the body.
  • UNII 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • UNII 89B2BSF9I3
    A synthetic compound made by chemically combining corn dextrin (a starch derivative) with palmitic acid. It acts as a binder and flow agent, helping hold tablet ingredients together and improve powder handling during manufacturing.
  • UNII F4K100DXP3
    Dibutyl adipate is a synthetic oily liquid derived from adipic acid. It serves as a plasticizer and solvent in medicines, helping softens coatings and improves flexibility so tablets and capsules don't crack or break.
  • 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.
  • UNII I0DQJ7YGXM
    A synthetic chemical compound used as a plasticizer in pharmaceutical coatings. It makes film coatings more flexible and durable so they don't crack or peel during manufacturing and storage.
  • UNII P7E6YFV72X
    Diisopropyl adipate is a clear, oily liquid derived from adipic acid. It acts as a plasticizer and solvent in medicines, helping soften coatings and improve how the drug dissolves or spreads in the body.
  • UNII 1F2S8T535O
    A synthetic polymer made from fatty acids and a chemical compound that binds ingredients together. It works as a binder and film-former in solid dosage forms, helping hold tablets together and coat their surface.
  • 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 H895X08VNQ
    A silicone-based polymer that forms small, hard particles. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
  • 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.
  • UNII OU4GI2R2WB
    A blend of fragrance compounds that adds a fresh citrus and floral scent to the medicine. Fragrances mask unpleasant tastes or odors to make the product more pleasant to use.
  • UNII G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII 5LKW3C543X
    A synthetic oily liquid derived from neopentyl glycol and heptanoic acid. It serves as an emollient and solvent in formulations, helping to dissolve or suspend active ingredients and improve the texture and spreadability of topical products.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • 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 8K8B5SD7ZR
    A synthetic plastic material made by combining two types of vinyl polymers. It acts as a film-former and binder in medications, helping create tablets or coatings that hold ingredients together and control how the medicine dissolves.
  • 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.
  • UNII 97K5YEF88C
    A clay-based ingredient used as a suspending agent and thickener in liquid medicines. It helps keep solid particles evenly distributed throughout the product so the medication mixes properly when shaken.
  • 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.
  • 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.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 2P6O7CFW5K
    Triheptanoin is a synthetic fat made from glycerol and seven-carbon fatty acids. It's used as a caloric supplement and carrier in certain formulations to deliver active ingredients and provide nutritional support.
  • 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.

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

The official label also statesdicaprylyl carbonate, butylene glycoldicaprylate/dicaprate, silica dimethyl silylate, neopentyl glycoldiheptanoate, dibutyl adipate, dimethicone, dextrin palmitate, coco-caprylate/caprate, acetyl ethylhexyl polyhydroxystearate, butyloctylsalicylate, diethylhexyl 2,6-naphthalate, diisopropyl adipate, poly C10-30alkyl acrylate, triheptanoin, silica, alcohol denat., 4-butylresorcinol,dimethicone/vinyl dimethicone crosspolymer, niacinamide, stearalkoniumhectorite, dimethicone crosspolymer, C12-15 alkyl benzoate, 12-hydroxy stearic acid, dilinoleic acid/butanediol copolymer, propylene carbonate,ethylhexyl palmitate, hydroxyacetophenone, quaternium-90 bentonite,fragrance, stearic acid, castor oil/IPDI copolymer, water, 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 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.
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
Coppertone Every Tone Brightening Sunscreen SPF 60 5 g/100g; 10 g/100g; 3 g/100g; 15 g/100gthis 66800-8000-01 Beiersdorf 1 bottle 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
Oct 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
66800-8000-01 You're viewing this 1 BOTTLE, PUMP in 1 CARTON (66800-8000-1) / 50 g in 1 BOTTLE, PUMP 2024-10-15 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 — Not published for this NDC No photo available yet for this listing.
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 66800-8000-1, 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: 66800-8000-01, written without dashes as 66800800001. 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 66800-8000-01, the first segment (66800) is the labeler code FDA assigned to Beiersdorf Inc; the middle segment (8000) 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 Beiersdorf Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Beiersdorf 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 5 words

Uses ■ helps prevent sunburn

⏱️ Dosage and Administration 98 words

Directions ■ apply liberally 15 minutes before sun exposure ■ reapply at least every 2 hours ■ use a water resistant sunscreen if swimming or sweating ■ 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-sleeve shirts, pants, hats, and sunglasses ■ children under 6 months: Ask a doctor

⚠️ Warnings 5 words

Warnings For external use only

🧪 Active Ingredient 10 words

Active ingredients Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

🧪 Inactive Ingredients 62 words

Inactive ingredients dicaprylyl carbonate, butylene glycoldicaprylate/dicaprate, silica dimethyl silylate, neopentyl glycoldiheptanoate, dibutyl adipate, dimethicone, dextrin palmitate, coco-caprylate/caprate, acetyl ethylhexyl polyhydroxystearate, butyloctylsalicylate, diethylhexyl 2,6-naphthalate, diisopropyl adipate, poly C10-30alkyl acrylate, triheptanoin, silica, alcohol denat., 4-butylresorcinol,dimethicone/vinyl dimethicone crosspolymer, niacinamide, stearalkoniumhectorite, dimethicone crosspolymer, C12-15 alkyl benzoate, 12-hydroxy stearic acid, dilinoleic acid/butanediol copolymer, propylene carbonate,ethylhexyl palmitate, hydroxyacetophenone, quaternium-90 bentonite,fragrance, stearic acid, castor oil/IPDI copolymer, water, 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 ↗
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.