Home › NDC Lookup › Ingredients › Avobenzone 3%, Homosalate 9%, Octisalate... › 66800-4839-05
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9% 9 g/100g; 4.5 g/100g; 9 g/100g; 3 g/100g Lotion, 177 g — NDC 66800-4839-05 package photo

Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9% 9 g/100g; 4.5 g/100g; 9 g/100g; 3 g/100g Lotion, 177 g

by Beiersdorf Inc · 177 g in 1 BOTTLE, PLASTIC (66800-4839-5)
NDC 66800-4839-05
🏷️ FDA NDC (as labeled) 66800-4839-5 billing pads the package segment with a zero
This package
Contains177 g Pack sizes2 compare ↓
Also comes in: 177 g 66800-4839-06
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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) 66800-4839-5
Product NDC 66800-4839
11-digit billing NDC 66800483905
UNII V06SV4M95S, 4X49Y0596W, 5A68WGF6WM, G63QQF2NOX
UPC 0072140034436
Application # M020
SPL Set ID d3d471b8-7430-98b0-e053-2995a90aba4b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-12-29
Route TOPICAL
Dosage form LOTION
Substance HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
Why two NDCs? The FDA registers this code as 66800-4839-5 — 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 → 66800-4839-05. 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 marketedDec 2021
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?

Coppertone Waterbabies Pure and Simple is a topical lotion sunscreen formulated for over-the-counter use under FDA's sunscreen monograph rules. It contains four UV-filtering agents (avobenzone, homosalate, octisalate, and octocrylene) that work together to absorb ultraviolet light and are commonly included in sunscreen products. The lotion is designed to be applied to the skin to help reduce sun exposure. SPF 50 indicates the product's ultraviolet B protection level according to standard testing methods.

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.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 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 4GXD0Q3OS3
    A synthetic polymer made from acrylic compounds, crosslinked to form a network structure. It acts as a thickener, stabilizer, and suspending agent in liquid and gel formulations, helping maintain consistent texture and keep ingredients evenly distributed.
  • UNII A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • 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 6V475AX06U
    A chelating agent derived from ethylenediaminetetraacetic acid (EDTA) combined with copper. It binds metals in formulations to prevent discoloration and degradation, helping preserve the medicine's stability and appearance.
  • UNII XQQ9MKE2BJ
    Eicosyl povidone is a synthetic polymer derived from povidone with added long-chain fatty components. It functions as a solubilizer and absorption enhancer to help the medicine dissolve better and be absorbed more effectively by the body.
  • 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 WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 836SJG51DR
    Sodium ascorbyl phosphate is a derivative of vitamin C that acts as an antioxidant and preservative in medications. It helps protect the drug's active ingredients from degradation caused by air and light exposure.
  • UNII 5Z4DPO246A
    A synthetic plastic polymer made from styrene and acrylamide monomers. It acts as a film-former and binder in tablets and capsules, helping hold ingredients together and control how quickly the medicine dissolves and releases in your body.
  • 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 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.

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

The official label also stateswater, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, styrene/acrylates copolymer, butylene glycol, VP/Eicosene copolymer, 1,2-hexanediol, hydroxyacetophenone, aloe barbadensis leaf juice, tocopherol, acrylates/C10-30 alkyl acrylate crosspolymer, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate

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 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: 177 g
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 Waterbabies Sunscreen SPF 50 9 g/100g; 4.5 g/100g; 9 g/100g; 3 g/100g 66800-4109-00 Beiersdorf 296 g — — FDA listed —
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 9 g/100g; 4.5 g/100g; 9 g/100g; 3 g/100gthis 66800-4839-05 Beiersdorf 177 g — — 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

🏛️
2021
On the market since
Dec 2021
📍
2026
Currently FDA-listed
5 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 Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 (this brand).

Top reported reactions

Sepsis2
Abdominal Abscess1
Abscess1
Blood Magnesium Decreased1
Bradycardia1
Candida Infection1
Candida Test Positive1

Reporter sex

3 reports
Male · 67%
Female · 33%

Serious outcomes

Hospitalization3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1 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
66800-4839-06 177 g in 1 TUBE (66800-4839-6) 2021-12-02 Active
66800-4839-05 You're viewing this 177 g in 1 BOTTLE, PLASTIC (66800-4839-5) 2021-12-29 Active

Pack size FAQ

What quantity is in NDC 66800-4839-05?
NDC 66800-4839-05 contains 177 g — 177 g in 1 bottle, plastic.
What is the difference between NDC 66800-4839-05 and NDC 66800-4839-06?
Both are Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9% 9 g/100g; 4.5 g/100g; 9 g/100g; 3 g/100g Lotion — the drug itself is identical. NDC 66800-4839-05 is the 177 g package, while NDC 66800-4839-06 is the 177 g package.
What NDC number is used to bill for this package of Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9% 9 g/100g; 4.5 g/100g; 9 g/100g; 3 g/100g Lotion?
Bill NDC 66800-4839-05 — the 11-digit billing format is 66800483905. 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 66800-4839-5, 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: 66800-4839-05, written without dashes as 66800483905. 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 66800-4839-05, the first segment (66800) is the labeler code FDA assigned to Beiersdorf Inc; the middle segment (4839) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 177 g (66800-4839-06). 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?
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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 31 words ▾

Uses ■ helps prevent sunburn ■ if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

⏱️ Dosage and Administration 103 words ▾

Directions ■ apply liberally 15 minutes before sun exposure ■ reapply: ■ after 80 minutes of swimming or sweating ■ immediately after towel drying ■ at least every 2 hours ■ 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 9%, Octisalate 4.5%, Octocrylene 9%

🧪 Inactive Ingredients 33 words ▾

Inactive ingredients water, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, styrene/acrylates copolymer, butylene glycol, VP/Eicosene copolymer, 1,2-hexanediol, hydroxyacetophenone, aloe barbadensis leaf juice, tocopherol, acrylates/C10-30 alkyl acrylate crosspolymer, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate

🎯 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 ↗
← 66800-4744-05 · Beiersdorf 66800-5000-04 · Beiersdort →
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.