UV Daily Hydration Tinted octisalat and zinc oxide sunscreen 50 g/1000g; 110 g/1000g Lotion, 48 g — NDC 72043-2816-01 package photo

UV Daily Hydration Tinted octisalat and zinc oxide sunscreen 50 g/1000g; 110 g/1000g Lotion, 48 g

by CP Skin Health Group, Inc · 48 g in 1 BOTTLE (72043-2816-1)
NDC 72043-2816-01
🏷️ FDA NDC (as labeled) 72043-2816-1 billing pads the package segment with a zero
This package
Contains48 g Pack sizes2 compare ↓
Also comes in: 2 g 72043-2816-02
OTC On market Non-controlled
🗂️ Data synced Jul 24, 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) 72043-2816-1
Product NDC 72043-2816
11-digit billing NDC 72043281601
UNII 4X49Y0596W, SOI2LOH54Z
UPC 0827854022466
Application # M020
SPL Set ID 02e71602-13e1-43b3-9cba-a75e46cccacc
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-18
Route TOPICAL
Dosage form LOTION
Substance OCTISALATE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 72043-2816-1 — 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 → 72043-2816-01. 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

LabelerCP Skin Health Group, Inc
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code72043
First marketedMay 2026
Product typeHuman Otc Drug
Portfolio19 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?

UV Daily Hydration Tinted is an over-the-counter lotion applied to the skin that contains two active ingredients used as sunscreens. Octisalate and zinc oxide are both mineral and chemical UV filters that are commonly included in sunscreen products to help block ultraviolet radiation from the sun. This product is marketed under FDA's monograph rules for over-the-counter sunscreen drugs rather than as an individually approved new drug application.

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 brown
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 WR1WPI7EW8
    A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • 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 331KBJ17RK
    Canola oil is a plant-based oil derived from rapeseed. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and may improve how the body absorbs certain medications.
  • UNII 8HO6PVN24W
    Carnosine is a naturally occurring compound made from two amino acids. In medicines, it may serve as a buffer to help maintain the product's pH stability.
  • 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 09FUA47KNA
    Cetearyl glucoside is a plant-derived surfactant made from vegetable oils and glucose. It helps oils and water mix together in creams and lotions, and can also soften and smooth the skin feel of the product.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 S3KFG6Q5X8
    An organic chemical compound used as a UV filter in topical formulations. It helps protect the medicine or product from degradation caused by sunlight exposure during storage and use.
  • 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 EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 86FQE96TZ4
    A synthetic polymer, this ingredient acts as a thickener and suspending agent in liquid formulations. It helps maintain uniform consistency and keeps particles evenly distributed throughout the medicine.
  • UNII 8CRQ2TH63M
    Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
  • UNII 772Y4UFC8B
    Octyl stearate is an oily compound made from stearic acid and octanol. It works as a lubricant and emollient in medicines to help them flow smoothly during manufacturing and reduce sticking.
  • UNII X8725R883T
    A synthetic oily liquid derived from branched carboxylic acids, used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product's texture while improving how it spreads on skin.
  • UNII 8Q0Z18J1VL
    A surfactant derived from oleic acid, a naturally occurring fatty acid. It helps mix oil and water-based ingredients together in formulations, improving product stability and texture.
  • UNII 0345752X7U
    A synthetic compound made from polyethylene glycol, glucose, and stearic acid. It acts as an emulsifier to help blend oil and water-based ingredients, and improves how the medicine dissolves and is absorbed in the body.
  • UNII MVJ3AD73GG
    A synthetic liquid derived from coconut oil and polyethylene glycol, used as an emulsifier and solubilizer to help mix water and oil-based ingredients and improve how the medicine dissolves and spreads throughout the formulation.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • 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 6QR7NJP3G8
    A synthetic polymer used as a thickening agent and viscosity modifier in liquid formulations. It helps control the medicine's flow and consistency, making it easier to pour, mix, or apply properly.
  • UNII 5XB3A63Y52
    A synthetic rubber polymer used as a glidant and lubricant in tablet and capsule formulations. It reduces friction between particles and equipment surfaces, helping medicines flow smoothly during manufacturing and preventing sticking.
  • UNII C2BRV53B1V
    A plant-derived oil from pongamia seeds used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product texture while improving how it spreads on skin.
  • 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 LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII SAS9Z1SVUK
    A natural oil extracted from ginger root that adds flavor and aroma to the medicine. It may also serve as a preservative or help mask unpleasant tastes in the formulation.

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

The official label also stateswater, petrolatum, isopropyl palmitate, butyloctyl salicylate, ethylhexyl methoxycrylene, cetearyl alcohol, dimethicone, phenoxyethanol, oleth-3 phosphate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, PEG-20 methyl glucose seesquistearate, polyisobutene, cetearyl glucoside, pongamia pinnata seed extract, octyldodecyl neopentanoate, ethylhexyl stearate, polyether-1, tocopheryl acetate, carnosine, ethylhexylglycerin, bisabolol, tocopherol, PEG-7 trimethylolpropaane cocunt ether, sodium hyaluronate, triethoxycaprylylsilane, zingier officinale (ginger) root extract, iron oxides

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: 2 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
UV Daily Hydration Tinted 50 g/1000g; 110 g/1000gthis 72043-2816-01 CP 48 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

🏛️
2026
On the market since
May 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
72043-2816-01 You're viewing this 48 g in 1 BOTTLE (72043-2816-1) 2026-05-18 Active
72043-2816-02 2 g in 1 PACKET (72043-2816-2) 2026-05-18 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 72043-2816-01?
NDC 72043-2816-01 contains 48 g — 48 g in 1 bottle.
What is the difference between NDC 72043-2816-01 and NDC 72043-2816-02?
Both are UV Daily Hydration Tinted octisalat and zinc oxide sunscreen 50 g/1000g; 110 g/1000g Lotion — the drug itself is identical. NDC 72043-2816-01 is the 48 g package, while NDC 72043-2816-02 is the 2 g package.
What NDC number is used to bill for this package of UV Daily Hydration Tinted octisalat and zinc oxide sunscreen 50 g/1000g; 110 g/1000g Lotion?
Bill NDC 72043-2816-01 — the 11-digit billing format is 72043281601. 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 72043-2816-1, 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: 72043-2816-01, written without dashes as 72043281601. 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 72043-2816-01, the first segment (72043) is the labeler code FDA assigned to CP Skin Health Group, Inc; the middle segment (2816) 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 CP Skin Health Group, 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 2 g (72043-2816-02). 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?
CP Skin Health Group, 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 29 words

Uses Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

⏱️ Dosage and Administration 93 words

Directions Apply liberally to face and neck 15 minutes before sun exposure. Use a water resistant sunsccreen if swimming or sweating, reapply 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

⚠️ Warnings 50 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 physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 7 words

Active Ingredients Octisalate 5.0% Zinc Oxide 11.0%

🧪 Inactive Ingredients 57 words

Inactive ingredients water, petrolatum, isopropyl palmitate, butyloctyl salicylate, ethylhexyl methoxycrylene, cetearyl alcohol, dimethicone, phenoxyethanol, oleth-3 phosphate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, PEG-20 methyl glucose seesquistearate, polyisobutene, cetearyl glucoside, pongamia pinnata seed extract, octyldodecyl neopentanoate, ethylhexyl stearate, polyether-1, tocopheryl acetate, carnosine, ethylhexylglycerin, bisabolol, tocopherol, PEG-7 trimethylolpropaane cocunt ether, sodium hyaluronate, triethoxycaprylylsilane, zingier officinale (ginger) root extract, iron oxides

🎯 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.