Babo Botanicals Daily Dew Milk Mineral Sunscreen SPF 27 Zinc Oxide 170 mg/mL Lotion
by Babo Botanicals, Inc. · 1 TUBE in 1 CARTON (79265-8062-0) / 50 mL in 1 TUBE
NDC 79265-8062-00
🏷️ FDA NDC (as labeled)
79265-8062-0
billing pads the package segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Aug 6, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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
FDA NDC (as labeled)
79265-8062-0
Product NDC
79265-8062
11-digit billing NDC
79265806200
UNII
SOI2LOH54Z
Application #
M020
SPL Set ID
54db8d28-2bb5-3ae4-e063-6294a90aa5ad
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-08-01
Route
TOPICAL
Dosage form
LOTION
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 79265-8062-0 — 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 → 79265-8062-00. 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
LabelerBabo Botanicals, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code79265
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio24 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 lotion sunscreen marketed as an over-the-counter monograph product. It contains zinc oxide, a mineral UV filter that is typically used to protect skin from ultraviolet (UV) radiation from the sun. Zinc oxide works by sitting on top of the skin and reflecting UV rays away. This product is formulated at SPF 27 strength, indicating a moderate level of sun protection.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:
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.
💬 Questions about Zinc Oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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UNII TR046Y3K1G
A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
-
UNII 114P5I43UJ
A hydrocarbon oil derived from petroleum, containing 13 to 15 carbon atoms per molecule. It serves as a lubricant and glidant in tablets and capsules to reduce friction during manufacturing and improve powder flow.
-
UNII P0M7O4Y7YD
A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
-
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 FGL3685T2X
Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
-
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 8D9H4QU99H
A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
-
UNII 37GVN739ZQ
A plant extract from meadowsweet leaves used as a natural flavoring agent or botanical ingredient. It may also serve as a mild preservative or sensory enhancer in the formulation.
-
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 958BJW095Q
A plant-based oil derived from white lupin seeds. It acts as an emollient and skin-conditioning agent in topical formulations, helping to soften and smooth the product texture while improving how it spreads on skin.
-
UNII YH89GMV676
A plant extract from watercress used as a natural flavoring or coloring agent in medications. It may help mask taste or add color to the formulation.
-
UNII 25X51I8RD4
Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
-
UNII MCA43PK7MH
Octyldodecyl oleate is a synthetic oil derived from oleic acid. It's used in medicines as an emollient and lubricant to improve texture, help ingredients mix smoothly, and enhance skin feel in topical formulations.
-
UNII F3VOA31UHQ
A natural oil extracted from passion fruit seeds. It serves as an emollient and skin-conditioning agent in topical products, helping to soften and moisturize the formulation while improving texture and spreadability.
-
UNII 598RES7AXX
A synthetic emulsifier derived from glycerin and oleic acid. It helps mix oil and water components in formulations, improving texture and stability of creams, lotions, or suspensions.
-
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 YXH47AOU0F
A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
-
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 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 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 6AXM7XCV3D
A natural oil extract from wheat germ that contains compounds resistant to saponification. Used in formulations as an emollient and conditioning agent to improve texture and skin feel.
-
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.
24 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesDaily Dew Milk Mineral Sunscreen SPF 27 Water (Aqua), Caprylic/Capric Triglyceride, C13-15 Alkane, Coco-Caprylate/Caprate, Propanediol, Polyglyceryl-6 Polyricinoleate, Stearyl/Octyldodecyl Citrate Crosspolymer, Polyhydroxystearic Acid, Polyglyceryl-10 Dioleate, Niacinamide, Lupinus Albus Seed Oil, Passiflora Edulis (Maracuja) Seed Oil, Triticum Vulgare (Wheat) Germ Oil Unsaponifiables, Octyldodecyl Oleate, Xanthan Gum, Caprylhydroxamic Acid, Helianthus Annuus (Sunflower) Seed Oil, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Nasturtium Officinale (Watercress) Extract, Spiraea Ulmaria (Meadowsweet) Flower Extract, Sodium Chloride, 1,2-Hexanediol, Iron Oxides. Daily Dew Milk Tinted Mineral Sunscreen SPF 27 Water (Aqua), Caprylic/Capric Triglyceride, C13-15 Alkane, Coco-Caprylate/Caprate, Propanediol, Polyglyceryl-6 Polyricinoleate, Stearyl /Octyldodecyl Citrate Crosspolymer, Polyhydroxystearic Acid, Polyglyceryl-10 Dioleate, Niacinamide, Lupinus Albus Seed Oil, Passiflora Edulis (Maracuja) Seed Oil, Triticum Vulgare (Wheat) Germ Oil Unsaponifiables, Helianthus Annuus (Sunflower) Seed Oil, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Nasturtium Officinale (Watercress) Extract, Spiraea Ulmaria (Meadowsweet) Flower Extract, Sodium Chloride, 1,2-Hexanediol, Octyldodecyl Oleate, Xanthan Gum, Caprylhydroxamic Acid, 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 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 system | Per g | Per 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
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
Aug 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.
🔬 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 Babo Botanicals Daily Dew Milk Mineral Sunscreen SPF 27 (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 37%
Female · 63%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 79265-8062-00 You're viewing this | 1 TUBE in 1 CARTON (79265-8062-0) / 50 mL in 1 TUBE | 2026-08-01 | 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 79265-8062-0, 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: 79265-8062-00, written without dashes as 79265806200. 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 79265-8062-00, the first segment (79265) is the labeler code FDA assigned to Babo Botanicals, Inc.; the middle segment (8062) 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 Babo Botanicals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Babo Botanicals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
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 ▾
Directions • Apply liberally 15 minutes before sun exposure. • Use water resistant sunscreen if swimming or sweating • Reapply at least every two 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 protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months: ask a doctor
⚠️ Warnings ▾
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 doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
🧪 Active Ingredient ▾
Active Ingredient Zinc Oxide 17%
🧪 Inactive Ingredients ▾
Inactive ingredients: Daily Dew Milk Mineral Sunscreen SPF 27 Water (Aqua), Caprylic/Capric Triglyceride, C13-15 Alkane, Coco-Caprylate/Caprate, Propanediol, Polyglyceryl-6 Polyricinoleate, Stearyl/Octyldodecyl Citrate Crosspolymer, Polyhydroxystearic Acid, Polyglyceryl-10 Dioleate, Niacinamide, Lupinus Albus Seed Oil, Passiflora Edulis (Maracuja) Seed Oil, Triticum Vulgare (Wheat) Germ Oil Unsaponifiables, Octyldodecyl Oleate, Xanthan Gum, Caprylhydroxamic Acid, Helianthus Annuus (Sunflower) Seed Oil, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Nasturtium Officinale (Watercress) Extract, Spiraea Ulmaria (Meadowsweet) Flower Extract, Sodium Chloride, 1,2-Hexanediol, Iron Oxides.
Daily Dew Milk Tinted Mineral Sunscreen SPF 27 Water (Aqua), Caprylic/Capric Triglyceride, C13-15 Alkane, Coco-Caprylate/Caprate, Propanediol, Polyglyceryl-6 Polyricinoleate, Stearyl /Octyldodecyl Citrate Crosspolymer, Polyhydroxystearic Acid, Polyglyceryl-10 Dioleate, Niacinamide, Lupinus Albus Seed Oil, Passiflora Edulis (Maracuja) Seed Oil, Triticum Vulgare (Wheat) Germ Oil Unsaponifiables, Helianthus Annuus (Sunflower) Seed Oil, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Nasturtium Officinale (Watercress) Extract, Spiraea Ulmaria (Meadowsweet) Flower Extract, Sodium Chloride, 1,2-Hexanediol, Octyldodecyl Oleate, Xanthan Gum, Caprylhydroxamic Acid, Iron Oxides.
🎯 Purpose ▾
Purpose Sunscreen
No label section mentions that — try another word, or open the full label on DailyMed below.
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.