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Mineral Sun Drops Zinc Oxide 220 mg/mL Lotion — NDC 69949-025-01 (Billing 69949-0025-01)

by Synchronicity Spa, Inc. DBA Suntegrity · 1 BOTTLE, DROPPER in 1 BOX / 30 mL in 1 BOTTLE, DROPPER

This is a package of Mineral Sun Drops Zinc Oxide 220 mg/mL Lotion from Synchronicity Spa, Inc. DBA Suntegrity, marketed since Aug 2025 and currently FDA-listed. It is this product's only package size.

NDC 69949-0025-01
🏷️ FDA NDC (as labeled) 69949-025-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 69949-025-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69949 labeler · 025 product · 01 package
Package marketed since
Aug 15, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0854245006705
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69949-025-01
Product NDC 69949-025
11-digit billing NDC 69949002501
UNII SOI2LOH54Z
UPC 0854245006705
Application # M020
SPL Set ID d8acda81-4430-42f8-be56-d28bb010e630
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-08-15
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 69949-025-01 — 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 → 69949-0025-01. 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.

Clinical

🧪 What is this product?

Mineral Sun Drops is a topical lotion containing zinc oxide, a mineral sunscreen ingredient. Zinc oxide is commonly used in sunscreen and sun protection products to help block ultraviolet (UV) light from reaching the skin. This product is marketed as an over-the-counter drug under FDA's monograph rule for sunscreen ingredients, meaning it follows established safety and effectiveness standards for that category rather than undergoing individual product review.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (3 interactions) — ranked by severity →
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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
69949-0025-01 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 BOX / 30 mL in 1 BOTTLE, DROPPER 2025-08-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Suzanne Organics Tinted Mineral Sunscreen Broad Spectrum SPF 25 - Sand 220 mg/mL 15435-0300-04 SLC 60 ml — — FDA listed —
Suzanne Organics Tinted Mineral Sunscreen Broad Spectrum SPF 25 - Bronze 220 mg/mL 15435-0310-04 SLC 60 ml — — FDA listed —
Active Argan 365 Spf 30 Broad Spectrum Activated Argan Complex 220 mg/mL 70803-0250-01 SIBORG 1 bottle — — FDA listed —
Gin Amber Beauty Mineral Sunscreen Broad Spectrum SPF 25 BB Cream 220 mg/mL 82618-0320-04 Gin 59 ml — — FDA listed —
SPF 30 Daily Sunscreen 220 mg/mL 81136-0001-01 Brand 1 tube — — Discontinued —
Mineral Sun Drops 220 mg/mLthis 69949-0025-01 Synchronicity 1 bottle — — FDA listed —
Odacite Color Balm - Golden Hour 220 mg/mL 82088-0500-02 Odacite 1 jar — — FDA listed —
Odacite Color Balm - Sienna Rose 220 mg/mL 82088-0499-02 Odacite 1 jar — — FDA listed —
Charlis Neutral Tinted Face Moisturizer Mineral Sunscreen SPF 25 220 mg/mL 85566-0322-01 CHARLIS 1 jar — — FDA listed —
Odacite Color Balm - Bronze Jolie 220 mg/mL 82088-0498-02 Odacite 1 jar — — FDA listed —
Dolce Glow Body Balm 220 mg/mL 83869-2167-02 Dolce 1 jar — — FDA listed —
Odacite Color Balm - Frosted Petal 220 mg/mL 82088-0501-02 Odacite 1 jar — — 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
Aug 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.

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 36HQN158VC
    Alpha-bisabolol is a naturally derived oily liquid from plant sources. It works as a fragrance, flavor, and skin-conditioning agent in topical medicines and cosmetic products.
  • 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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • 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 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 N7YC58165T
    A synthetic polymer made from glycerin and sebacic acid, used as a film-former and binder in medications. It helps hold tablet or capsule ingredients together and may coat the product for controlled release.
  • UNII 609A3V1SUA
    A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
  • 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 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 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 981F40Q9FF
    A synthetic oil derived from isostearic acid, used as an emollient and lubricant in topical formulations. It helps soften the skin and improves the spreadability and texture of creams and lotions.
  • UNII 88496G1ERL
    Sodium phytate is a plant-derived salt used in medications as a chelating agent and preservative. It helps stabilize formulations and may improve how the body absorbs certain minerals in the medicine.
  • UNII 90TF85HH91
    A fatty substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water-based ingredients together in the medicine, and may also help with texture and consistency.
  • UNII 9229XJ4V12
    A synthetic emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients in formulations, keeping them mixed and preventing separation.
  • UNII 687U3PEB2Y
    A complex emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients together and improves the texture and stability of creams, lotions, and other formulated products.
  • UNII 8Y19QCY6I4
    Pongamol is a naturally occurring compound derived from Pongamia pinnata plant seeds. In medicines, it serves as an antimicrobial and antioxidant agent to help preserve product stability and prevent degradation.
  • UNII CH428W5O62
    A plant-derived emulsifier made from jojoba oil that has been chemically broken down and converted to potassium salts. It helps mix oil and water-based ingredients together in the formulation and improves product texture and stability.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • 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 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 24SC3U704I
    A powdery carbohydrate extracted from tapioca plant roots. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your digestive system.
  • 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.

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

The official label also statesAloe Barbadensis Leaf Juice and Water, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Propanediol, Jojoba Esters, Methylheptyl Isostearate, Polyglyceryl-10 Stearate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Hydrogenated Methyl Abietate, Caprylol Glycerin/Sebacic Acid Copolymer, Polyglyceryl-2 Dipolyhydroxystearate, Caprylhydroxamic acid (and) Glyceryl Caprylate (and) Glycerin, Tapioca Starch, Sorbitan Sesquioleate, Lecithin, Pongamia Pinnata Seed Extract, Tocopherol, Bisabolol, Sodium Phytate, Allantoin.

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.

Manufacturer & labeler

LabelerSynchronicity Spa, Inc. DBA Suntegrity
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code69949
First marketedAug 2025
Product typeHuman Otc Drug
Portfolio17 products on file

More NDCs from Synchronicity Spa, Inc. DBA Suntegrity labeler code 69949

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.

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 32 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 102 words ▾

Directions - Shake well before use. - Apply liberally 15 minutes before sun exposure. - Reapply: after 80 minutes of swimming or sweating; immediately after towel drying; at least every 2 hours - Children under 6 months: ask a doctor. - Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and skin early 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, expecially from 10am to 2pm – Wear long-sleeved shirts, pants, hats, and sunglasses.

⚠️ Warnings 59 words ▾

Warnings - For external use only - Do not use on damaged or broken skin - Stop use and 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.

📦 Storage and Handling 11 words ▾

Other Information Protect this product from excessive heat & direct sun

🧪 Active Ingredient 5 words ▾

Active Ingredient Zinc Oxide 22%

🧪 Inactive Ingredients 54 words ▾

Inactive Ingredients Aloe Barbadensis Leaf Juice and Water, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Propanediol, Jojoba Esters, Methylheptyl Isostearate, Polyglyceryl-10 Stearate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Hydrogenated Methyl Abietate, Caprylol Glycerin/Sebacic Acid Copolymer, Polyglyceryl-2 Dipolyhydroxystearate, Caprylhydroxamic acid (and) Glyceryl Caprylate (and) Glycerin, Tapioca Starch, Sorbitan Sesquioleate, Lecithin, Pongamia Pinnata Seed Extract, Tocopherol, Bisabolol, Sodium Phytate, Allantoin.

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 9 words ▾

- Do not use on damaged or broken skin

📄 When Using This Product 14 words ▾

- When using this product keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 10 words ▾

- Stop use and ask a doctor if rash occurs

📄 Keep Out of Reach of Children 20 words ▾

- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 3 words ▾

Questions? Call 888-786-5221

📄 Package Label / Principal Display Panel 42 words ▾

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box sun tegrity ® MINERAL SUN DROPS BROAD SPECTRUM SPF 30 SPF 30 NON-NANO ZINC OXIDE Water Resistant (80 Minutes) 30 mL ℮ 1 fl oz Lotion PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Mineral Sun Drops (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Age at onset

Neonate5
Infant8
Child28
Adolescent5
Adult110
Elderly192

Reporter sex

1,941 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization988
Death204
Life-threatening116
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 120 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.

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 — Not published for this NDC No photo available yet for this listing.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Synchronicity Spa, Inc. DBA Suntegrity. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Synchronicity Spa, Inc. DBA Suntegrity 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.
← 69949-0010-01 · Synchronicity 69949-0051-01 · Synchronicity →
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.