Home › NDC Lookup › Ingredients › Homosalate, Octisalate, Octocrylene, Avo... › 83735-0002-02
P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum Homosalate, Octisalate, Octocrylene, Avobenzone 2.7 g/100mL; 4.5 g/100mL; 9 g/100mL; 13.5 g/100mL Lotion — NDC 83735-0002-02 package photo

P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum Homosalate, Octisalate, Octocrylene, Avobenzone 2.7 g/100mL; 4.5 g/100mL; 9 g/100mL; 13.5 g/100mL Lotion

by LIFE WITHCORPORATION Inc. · 1 TUBE in 1 BOX (83735-002-02) / 50 mL in 1 TUBE (83735-002-01)
NDC 83735-0002-02
🏷️ FDA NDC (as labeled) 83735-002-02 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) 83735-002-02
Product NDC 83735-002
11-digit billing NDC 83735000202
UNII G63QQF2NOX, 4X49Y0596W, 5A68WGF6WM, V06SV4M95S
Application # M020
SPL Set ID 44ea9fb4-8e01-6969-e063-6294a90a6a94
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-01
Route TOPICAL
Dosage form LOTION
Substance AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE
Why two NDCs? The FDA registers this code as 83735-002-02 — 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 → 83735-0002-02. 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

LabelerLIFE WITHCORPORATION Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83735
First marketedFeb 2026
Product typeHuman Otc Drug
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?

P.CALM Water Barrier Sunscreen SPF 50 is a topical lotion marketed as an over-the-counter sunscreen product under FDA's monograph rules for sunscreen drugs. It contains four active ingredients: homosalate, octisalate, octocrylene, and avobenzone, which are ultraviolet (UV) filters commonly used together in sunscreen formulations to help absorb UVA and UVB radiation. This product is formulated as a lotion intended to be applied to the skin for sun protection purposes.

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 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 W59H9296ZG
    A synthetic polymer made from acrylic compounds and vinylpyrrolidone. It works as a film-former and thickener in topical products, helping create a smooth texture and improve how the medication spreads on skin.
  • 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 O4M0347C6A
    C20-22 alcohols are fatty alcohols derived from natural oils or fats. They act as emulsifiers and thickeners in medicines, helping blend oil and water-based ingredients and give the product its desired texture.
  • UNII L4VKP0Y7RP
    A synthetic chemical compound derived from fatty acids with 20-22 carbon atoms, combined with phosphate. It functions as an emulsifier and surfactant to help mix oil and water-based ingredients evenly throughout the medicine.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII Q95M2P1KJL
    A silicone-based ingredient that acts as a lubricant and glidant. It helps the tablet or capsule move smoothly through manufacturing equipment and improves powder flow during production.
  • UNII 7M867G6T1U
    Centella asiatica is a plant extract used in medicines as a skin-conditioning or soothing ingredient. It helps maintain product stability and may support skin comfort in topical formulations.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • 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 E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • 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 Q7UI015FF9
    A synthetic polymer material used as a thickener and stabilizer in liquid formulations. It helps create the right texture and prevents separation of ingredients in medicines and topical products.
  • UNII 59Z907ZB69
    A synthetic silicone polymer used as a glidant and anti-caking agent. It reduces friction between particles, helping powders and tablets flow smoothly during manufacturing and use.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • 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 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
  • UNII 035MV9S1C3
    A plastic-like polymer made from two chemical compounds joined together. It acts as a binder and film-former in tablets and capsules, helping hold ingredients together and create a protective coating on the medicine's surface.

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

The official label also statesWater, Butyloctyl Salicylate, Diethylhexyl 2,6-Naphthalate, Dipropylene Glycol, Panthenol, C20-22 Alkyl Phosphate, C20-22 Alcohols, 1,2-Hexanediol, Caprylyl Methicone, Silica, Pentylene Glycol, Cetyl Alcohol, Glyceryl Stearate, Polymethylsilsesquioxane, VP/Eicosene Copolymer,Tromethamine, Polyacrylate Crosspolymer-6, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ethylhexylglycerin, Hydrolyzed Sodium Hyaluronate, Tocopherol, Butylene Glycol, Centella Asiatica Extract, Camellia Sinensis Leaf Extract

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.
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
P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum 2.7 g/100mL; 4.5 g/100mL; 9 g/100mL; 13.5 g/100mLthis 83735-0002-02 LIFE 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

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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
83735-0002-02 You're viewing this 1 TUBE in 1 BOX (83735-002-02) / 50 mL in 1 TUBE (83735-002-01) 2026-02-01 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 83735-002-02, 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: 83735-0002-02, written without dashes as 83735000202. 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 83735-0002-02, the first segment (83735) is the labeler code FDA assigned to LIFE WITHCORPORATION Inc.; the middle segment (0002) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 LIFE WITHCORPORATION Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
LIFE WITHCORPORATION 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 28 words ▾

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

⏱️ Dosage and Administration 93 words ▾

apply liberally 15 minutes before sun exposure 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 children under 6 months of age: Ask a doctor reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating

⚠️ Warnings 149 words ▾

For external use only Do not use on damaged skin 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 rash occurs Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away apply liberally 15 minutes before sun exposure 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 children under 6 months of age: Ask a doctor reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating

🧪 Active Ingredient 7 words ▾

Avobenzone 2.7% Octisalate 4.5% Homosalate13.5% Octocrylene 9%

🧪 Inactive Ingredients 45 words ▾

Water, Butyloctyl Salicylate, Diethylhexyl 2,6-Naphthalate, Dipropylene Glycol, Panthenol, C20-22 Alkyl Phosphate, C20-22 Alcohols, 1,2-Hexanediol, Caprylyl Methicone, Silica, Pentylene Glycol, Cetyl Alcohol, Glyceryl Stearate, Polymethylsilsesquioxane, VP/Eicosene Copolymer,Tromethamine, Polyacrylate Crosspolymer-6, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ethylhexylglycerin, Hydrolyzed Sodium Hyaluronate, Tocopherol, Butylene Glycol, Centella Asiatica Extract, Camellia Sinensis Leaf Extract

🎯 Purpose 1 words ▾

sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 83733-0037-01 · Procurall 83737-0001-30 · Archie's →
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.