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Zinc Oxide Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/Light 20 mg/100mL Cream, 29 mL — NDC 61197-0314-00 package photo

Zinc Oxide Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/Light 20 mg/100mL Cream, 29 mL

by Pacifica Beauty, LLC · 29 mL in 1 BOTTLE, PUMP (61197-314-00)
NDC 61197-0314-00
🏷️ FDA NDC (as labeled) 61197-314-00 billing pads the product segment with a zero
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 →

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) 61197-314-00
Product NDC 61197-314
11-digit billing NDC 61197031400
UNII SOI2LOH54Z
Application # M020
SPL Set ID 373aba7c-2ae1-8726-e063-6294a90ae3d8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-01
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 61197-314-00 — 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 → 61197-0314-00. 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

LabelerPacifica Beauty, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code61197
First marketedApr 2025
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?

This is a topical cream foundation marketed as an OTC monograph sunscreen product. Zinc oxide is the active ingredient and functions as a physical (mineral) ultraviolet filter, typically used in sunscreen products to help protect skin from UV radiation. The product is formulated as a cosmetic foundation that combines sun protection with coverage, applied directly to facial skin. As an OTC monograph drug, it is marketed under established FDA guidelines for sunscreen ingredients rather than as an individually reviewed new drug application.

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 RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • UNII LZI0HJ3K2R
    A synthetic peptide (short chain of amino acids) used as a conditioning agent in topical formulations. It helps soften and smooth the skin or hair by forming a protective layer on the surface.
  • UNII UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • 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 6BJQ43T1I9
    A synthetic peptide made from copper and amino acids. It's used in topical formulations as an active conditioning or skin-support ingredient, though classified as an excipient in some product listings.
  • UNII NO0DI2V62B
    A plant extract from sea kale leaves used in cosmetic and personal care formulations as a skin-conditioning agent and moisturizer to help maintain product texture and feel.
  • UNII J7IHY79BKY
    A plant extract from glasswort, a coastal herb. It's used in formulations as a humectant to help retain moisture and may serve as a skin-conditioning agent in topical products.
  • UNII YY7C30VXJT
    A natural plant extract from cucumber that adds flavor and freshness to medicines. It may also serve as a moisturizing agent or mild preservative in topical or oral formulations.
  • UNII I8LHQ0D645
    Dextran 1 is a sugar-based polymer made from bacteria. In medicines, it acts as a binder and filler to hold tablet ingredients together and add bulk to 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 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 TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • 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 ZF94AP8MEY
    Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
  • UNII A23O709X8O
    A synthetic compound derived from rosin that acts as a film-forming agent and binder. It helps create a protective coating on tablets or capsules and improves how the medicine holds together during manufacturing and storage.
  • UNII UDR641JW8W
    A plant-derived oil from jojoba seeds that has been broken down into smaller components. It acts as an emollient and skin-conditioning agent to help soften and smooth the product's texture.
  • UNII S870P55O2W
    Isomalt is a sugar alcohol made from sugar that's used as a sweetener and bulking agent in medicines. It helps give tablets and powders the right texture and sweetness while having minimal calories.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII EF626V855K
    A plant extract from domestic apple flowers used as a natural flavoring agent and fragrance component in medicines. It adds taste and aroma to the product to improve palatability.
  • UNII MZQ63P0N0W
    A plant-derived emulsifier made from glycerin and castor oil. It helps mix oil and water ingredients together in formulations like creams and lotions, keeping them blended.
  • UNII YPM0ZOC2HR
    A synthetic emulsifier derived from glycerin and castor oil. It helps mix oil and water-based ingredients together in the formulation to create a uniform product and improve texture.
  • 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 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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 0W8RRI5W5A
    A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.
  • UNII PN88NW0KPK
    A synthetic polymer made from citric acid and long-chain alcohols. It acts as a thickener and stabilizer in creams and lotions, helping maintain consistent texture and prevent ingredient separation.
  • UNII 4938BNS0GU
    A fungal extract from tremella fuciformis, a jelly-like mushroom. It acts as a thickener, emulsifier, and skin-conditioning agent in topical formulations to improve texture and moisture retention.
  • UNII YQ5Q4Y2Z8U
    A plant-based oil extracted from grape seeds or fruit. It serves as an emollient and solvent in formulations, helping to dissolve or suspend active ingredients and improve how the medicine feels on skin or mucous membranes.
  • 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 TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesInactive ingredietns: aqua (eau), caprylic/capric triglyceride, aloe barbadensis leaf juice, polyglyceryl-3 polyricinoleate, glycerin, simmondsia chinensis (jojoba) seed oil, hydrogenated castor oil, sorbitan sesquioleate, hydrogenated methyl abietate, stearyl/octyldodecyl citrate crosspolymer, magnesium sulfate, cucumis sativus (cucumber), extract, malus domestica fruit cell culture extract, helianthus annuus (sunflower) seed oil, sodium hyaluronate, crithmum maritimum extract, crambe maritima leaf extract, vitis vinifera (grape) fruit cell extract, isomalt, lecithin, tremella fuciformis polysaccharide, dextran, caprooyl tetrapeptide-3, copper tripeptide-1, jojoba esters, polyglyceryl-6 polyricinoleate, fragrance (parfum), iron oxides (CI 77492), silica, caprylhydroxamic acid, glyceryl caprylate, ethylhexylglycerin, xanthan gum, sodium benzoate, iron oxides (CI 77491), iron oxides (CI 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 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
Zinc Oxide 20 mg/100mLthis 61197-0314-00 Pacifica 29 ml — — 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

🏛️
2025
On the market since
Apr 2025
📍
2026
Currently FDA-listed
1 year 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 Skin Protectant — the ingredient across all brands.

Top reported reactions

Macular Degeneration462
Pyrexia396
Nausea360
Malaise315
Pain314
Weight Decreased267
Diarrhoea245

Age at onset

Neonate5
Infant10
Child36
Adolescent12
Adult200
Elderly303

Reporter sex

3,197 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization1,740
Death442
Life-threatening239
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 423 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
61197-0314-00 You're viewing this 29 mL in 1 BOTTLE, PUMP (61197-314-00) 2025-04-01 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 61197-314-00, 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: 61197-0314-00, written without dashes as 61197031400. 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 61197-0314-00, the first segment (61197) is the labeler code FDA assigned to Pacifica Beauty, LLC; the middle segment (0314) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 Pacifica Beauty, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pacifica Beauty, LLC 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 30 words ▾

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

⏱️ Dosage and Administration 71 words ▾

Directions Directions Apply + reapply at least every 80 minutes. Sun protection measures. Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher & other sun protection measures including: -limit time in the sun, especially from 10 a.m. - 2 p.m. -wear long-sleeve shirts, pants, hats & sunglasses.

⚠️ Warnings 69 words ▾

Warnings Warnings For external use only. Do not use on damaged or broken skin. Stop use & ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Can stain clothing. Keep away from clothes. Children under 6 months: ask a doctor.

📦 Storage and Handling 13 words ▾

Other information Other information Protect this product from excessive heat & direct sun.

🧪 Active Ingredient 7 words ▾

Active ingredients Active ingredients Zinc Oxide 20%

🧪 Inactive Ingredients 101 words ▾

Inactive ingredients Inactive ingredietns: aqua (eau), caprylic/capric triglyceride, aloe barbadensis leaf juice, polyglyceryl-3 polyricinoleate, glycerin, simmondsia chinensis (jojoba) seed oil, hydrogenated castor oil, sorbitan sesquioleate, hydrogenated methyl abietate, stearyl/octyldodecyl citrate crosspolymer, magnesium sulfate, cucumis sativus (cucumber), extract, malus domestica fruit cell culture extract, helianthus annuus (sunflower) seed oil, sodium hyaluronate, crithmum maritimum extract, crambe maritima leaf extract, vitis vinifera (grape) fruit cell extract, isomalt, lecithin, tremella fuciformis polysaccharide, dextran, caprooyl tetrapeptide-3, copper tripeptide-1, jojoba esters, polyglyceryl-6 polyricinoleate, fragrance (parfum), iron oxides (CI 77492), silica, caprylhydroxamic acid, glyceryl caprylate, ethylhexylglycerin, xanthan gum, sodium benzoate, iron oxides (CI 77491), iron oxides (CI 77499).

🎯 Purpose 3 words ▾

Purpose Purpose Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61197-0313-00 · Pacifica 61197-0315-00 · Pacifica →
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.