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Farmasi BB Beauty Balm Cream SPF 15- 03 Medium TITANIUM DIOXIDE 35 mg/mL Cream — NDC 74690-0042-00 package photo

Farmasi BB Beauty Balm Cream SPF 15- 03 Medium TITANIUM DIOXIDE 35 mg/mL Cream

by Farmasi US LLC · 1 TUBE in 1 CARTON (74690-042-00) / 30 mL in 1 TUBE
NDC 74690-0042-00
🏷️ FDA NDC (as labeled) 74690-042-00 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) 74690-042-00
Product NDC 74690-042
11-digit billing NDC 74690004200
UNII 15FIX9V2JP
Application # M020
SPL Set ID 6ef986df-4044-4c32-8b64-f8110c9c9543
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-07-01
Route TOPICAL
Dosage form CREAM
Substance TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 74690-042-00 — 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 → 74690-0042-00. 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

LabelerFarmasi US LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code74690
First marketedJul 2023
Product typeHuman Otc Drug
Portfolio31 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?

Farmasi BB Beauty Balm Cream SPF 15 is a topical cream sold as an over-the-counter sunscreen product. The active ingredient, titanium dioxide, is a mineral UV filter commonly used in sunscreens to help block ultraviolet rays from the sun. This particular formulation is labeled as a BB cream, a type of cosmetic product that typically combines coverage and sun protection. The product is marketed and sold under FDA's established rules for over-the-counter sunscreen ingredients.

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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • 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 7CY8BVL34N
    Carrageenan sodium is a thickening agent derived from red seaweed. It's used in medicines to create a gel-like consistency, improve texture, and help the product hold together in liquid or semi-solid formulations.
  • UNII 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • 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 X687XDK09L
    A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
  • 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 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 ML9LGA7468
    A naturally-derived alcohol used as a preservative and fragrance in medicines. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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.

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

The official label also statesWater/Aqua, Cyclopentasiloxane, Butylene Glycol, PEG-10 Dimethicone, Dimethicone, Disteardimonium Hectorite, Tr i m e t h y l s i l o x y s i l i c a t e, Phenoxyethanol, Phenethyl Alcohol, Sodium Chloride, Sodium Carrageenan, Silica, Sea Salt/Maris Sal, Polymethylsilsesquioxane, Jojoba Esters, Tocopherol, Tocopheryl Acetate, E t h y l h e x y l g l y c e r i n, Triethoxycaprylylsilane, Fragrance. [+/- May Contain: Titanium  Dioxide/77891, Iron Oxides/CI 77491, CI 77492, CI77499.]

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
Farmasi BB Beauty Balm Cream SPF 15- 01 Light 35 mg/mL 74690-0040-00 Farmasi 1 tube — — FDA listed —
Farmasi BB Beauty Balm Cream SPF 15- 02 Light to Medium 35 mg/mL 74690-0041-00 Farmasi 1 tube — — FDA listed —
Farmasi BB Beauty Balm Cream SPF 15- 03 Medium 35 mg/mLthis 74690-0042-00 Farmasi 1 tube — — FDA listed —
Farmasi BB Beauty Balm Cream SPF 15- 04 Medium to Tan 35 mg/mL 74690-0043-00 Farmasi 1 tube — — FDA listed —
Farmasi BB Beauty Balm Cream SPF 15- 05 Tan 35 mg/mL 74690-0044-00 Farmasi 1 tube — — FDA listed —
Farmasi BB Beauty Balm Cream SPF 15- 06 Deep 35 mg/mL 74690-0045-00 Farmasi 1 tube — — FDA listed —
Farmasi BB Cream LIGHT to MEDIUM 02 35 mg/mL 78317-0052-00 TAN 1.5 ml — — FDA listed —
Farmasi BB Cream- MEDIUM 03 35 mg/mL 78317-0054-00 TAN 1.5 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

🏛️
2023
On the market since
Jul 2023
📍
2026
Currently FDA-listed
3 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 TITANIUM DIOXIDE — the ingredient across all brands.

Top reported reactions

Hypersensitivity27
Erythema25
Rash23
Pruritus20
Pain18
Abdominal Pain Upper15
Dyspnoea15

Age at onset

Child2
Adolescent3
Adult25
Elderly22

Reporter sex

0 reports
Male · 39%
Female · 60%
Unknown · 1%

Serious outcomes

Hospitalization83
Death36
Disabling21
Life-threatening17
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 52 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
74690-0042-00 You're viewing this 1 TUBE in 1 CARTON (74690-042-00) / 30 mL in 1 TUBE 2023-07-01 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 74690-042-00, 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: 74690-0042-00, written without dashes as 74690004200. 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 74690-0042-00, the first segment (74690) is the labeler code FDA assigned to Farmasi US LLC; the middle segment (0042) 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 Farmasi US LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Farmasi US 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 4 words ▾

Use: Helps prevent sunburn.

⏱️ Dosage and Administration 73 words ▾

Directions: · Apply 15 minutes before sun exposure.· 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. For Sunscreen Use Sun Protection Measures:

⚠️ Warnings 60 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 doctor if rash occurs. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Shake well before use.

🧪 Active Ingredient 7 words ▾

Active Ingredient: Titanium Dioxide 3.5% Purpose Sunscreen

🧪 Inactive Ingredients 83 words ▾

Inactive Ingredients: Water/Aqua, Cyclopentasiloxane, Butylene Glycol, PEG-10 Dimethicone, Dimethicone, Disteardimonium Hectorite, Tr i m e t h y l s i l o x y s i l i c a t e , Phenoxyethanol, Phenethyl Alcohol, Sodium Chloride, Sodium Carrageenan, Silica, Sea Salt/Maris Sal, Polymethylsilsesquioxane, Jojoba Esters, Tocopherol, Tocopheryl Acetate, E t h y l h e x y l g l y c e r i n , Triethoxycaprylylsilane, Fragrance. [+/- May Contain: Titanium Dioxide/77891, Iron Oxides/CI 77491, CI 77492, CI77499.]

🎯 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 ↗
← 74690-0041-00 · Farmasi 74690-0043-00 · Farmasi →
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.