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Lather Daily Defense Mineral SPF 45 Facial Sunscreen Zinc Oxide 19 g/100g Lotion, 1 bottle — NDC 77394-0204-02 package photo

Lather Daily Defense Mineral SPF 45 Facial Sunscreen Zinc Oxide 19 g/100g Lotion, 1 bottle

by Lather, Inc. · 1 BOTTLE, PUMP in 1 CARTON (77394-204-02) / 56.7 g in 1 BOTTLE, PUMP
NDC 77394-0204-02
🏷️ FDA NDC (as labeled) 77394-204-02 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

⚠️
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) 77394-204-02
Product NDC 77394-204
11-digit billing NDC 77394020402
UNII SOI2LOH54Z
UPC 0836583007521
Application # M020
SPL Set ID 50c732a0-b282-d61b-e063-6294a90aa76b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-06
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 77394-204-02 — 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 → 77394-0204-02. 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

LabelerLather, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code77394
First marketedMay 2026
Product typeHuman Otc Drug
Portfolio3 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?

Lather Daily Defense Mineral SPF 45 Facial Sunscreen is a lotion applied to the skin that contains zinc oxide as its active ingredient. Zinc oxide is a mineral sun filter typically used in sunscreen products to help protect skin from ultraviolet (UV) radiation. This product is marketed as an over-the-counter monograph drug, meaning it is made and sold under FDA's established rules for sunscreen products rather than as an individually approved application.

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.

🧪 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 EJ9JK8J58D
    A brown seaweed extract used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of liquid or semi-solid formulations.
  • 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 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 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 G3232Z5S2O
    A synthetic emollient and emulsifier derived from plant oils and glycerin. It helps blend oil and water components together and gives the product a smooth texture in topical formulations.
  • UNII XPD6ZY79TB
    A synthetic preservative derived from the amino acid arginine. It prevents microbial growth in medicines, helping 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 W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII SCJ765569P
    Holy basil leaf is a plant-derived ingredient used in some formulations as a flavoring agent or botanical additive. It may contribute taste and aroma to the medicine.
  • 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 M1SLX00M3M
    Isoamyl laurate is a synthetic ester made from isoamyl alcohol and lauric acid. It functions as an emollient and lubricant in topical formulations to help smooth and soften the skin.
  • 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 V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • UNII MJ95C3OH47
    A plant extract from olive leaves used in formulations as an antioxidant and preservative. It helps protect the medicine from degradation and extend shelf life.
  • UNII XRQ165498B
    A plant-derived emulsifier made from glycerin and oleic acid. It helps mix oil and water-based ingredients together in the formulation and improves product texture and stability.
  • UNII 8KQ7I65XZE
    A waxy compound derived from stearic acid, used as a thickener and emulsifier to help blend oil and water-based ingredients. It improves the texture and stability of the medicine formulation.
  • 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 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 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • 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 5EHL50I4MY
    A sodium salt compound used as a chelating agent in medicines. It binds to metals and minerals to improve stability, prevent discoloration, and help the medication stay effective longer.
  • 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 856YO1Z64F
    Turmeric is a natural spice derived from the turmeric plant root. It serves as a colorant in medicines, giving products a yellow or golden appearance, and may also provide mild flavoring.
  • 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.

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

The official label also statesWater (Aqua), Aloe Barbadensis leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Glycerin, Polyglyceryl-3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyceryl-3 Dime Dilinoleate, Mica, Caprylic/Capric Triglycride, Magnesium Sulfate, Squalane**, Camellia Sineis (Green Tea) Leaf Extract*, Olea Europa (Olive) Leaf Extract*, Curcuma Longa (Turmeeric) Root Extract*, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Oil, Alaria Esculenta (Wakame Seaweed) Extract, Ocimum Tenuiflorum (Tulsi) Leaf Extract*, Ethyl Lauroyl Arginate HCl, Mixed Tocopherols, Sodium Stearoyl Glutamate, Tetrasodium Glutamate Diacetate, Silica, Xanthan Gum, Iron Oxides (CI 77492, CI 44791, CI 77499), *Organic Ingredient **Olive

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
Wonderscreen Tinted Broad Spectrum SPF 30 19 g/100g 82870-0005-01 Dime 50 g — — FDA listed —
Zoey naturals Broad Spectrum SPF 50 Fragrance Free Sunscreen 19 g/100g 70793-0033-68 Absolutely 19.5 g — — FDA listed —
Lather Daily Defense Mineral SPF 45 Facial Sunscreen 19 g/100gthis 77394-0204-02 Lather, 1 bottle — — FDA listed —
Wonderscreen Broad Spectrum SPF 30 19 g/100g 44717-0062-01 Wasatch 50 g — — FDA listed —
Hustle Butter Spf 50 Mineral Sunscreen 19 g/100g 72014-0202-02 H.B.D.DIST. 19.5 g — — FDA listed —
Banana Boat 19 g/100g 63354-0373-01 Edgewell 74 g — — FDA listed —
SPF 30 Mineral Sunscreen 19 g/100g 83369-0003-01 Smalls 50 g — — FDA listed —
Baby Donna SHeer SPF Sunscreen Stick 19 g/100g 69555-0044-01 Stream2Sea, 16 g — — FDA listed —
Smart Care Mineral-Enhanced SUNSCREEN SPF 50 19 g/100g 70108-0269-01 Ashtel 170 g — — Discontinued —
Wonderscreen Broad Spectrum SPF 30 Shade 1 19 g/100g 82870-0007-01 Dime 50 g — — FDA listed —
Banana Boat 19 g/100g 63354-0374-23 Edgewell 147 g — — FDA listed —
Wonderscreen Tinted Broad Spectrum SPF 30 Shade 3 19 g/100g 82870-0008-01 Dime 50 g — — FDA listed —
Wonderscreen Broad Spectrum SPF 30 19 g/100g 82870-0001-01 Dime 50 g — — FDA listed —
Absolutely Natural Broad Spectrum SPF 50 Sunscreen 19 g/100g 70793-0035-68 Absolutely 19.5 g — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
77394-0204-02 You're viewing this 1 BOTTLE, PUMP in 1 CARTON (77394-204-02) / 56.7 g in 1 BOTTLE, PUMP 2026-05-06 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 77394-204-02, 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: 77394-0204-02, written without dashes as 77394020402. 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 77394-0204-02, the first segment (77394) is the labeler code FDA assigned to Lather, Inc.; the middle segment (0204) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Lather, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Lather, 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 29 words ▾

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

⏱️ Dosage and Administration 92 words ▾

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours. Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or. higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses children under 6 months: ask a doctor

⚠️ Warnings 34 words ▾

For external use only Do not use on damaged or broken sin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs

🧪 Active Ingredient 3 words ▾

Zinc Oxide 19%

🧪 Inactive Ingredients 84 words ▾

Water (Aqua), Aloe Barbadensis leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Glycerin, Polyglyceryl-3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyceryl-3 Dime Dilinoleate, Mica, Caprylic/Capric Triglycride, Magnesium Sulfate, Squalane**, Camellia Sineis (Green Tea) Leaf Extract*, Olea Europa (Olive) Leaf Extract*, Curcuma Longa (Turmeeric) Root Extract*, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Oil, Alaria Esculenta (Wakame Seaweed) Extract, Ocimum Tenuiflorum (Tulsi) Leaf Extract*, Ethyl Lauroyl Arginate HCl, Mixed Tocopherols, Sodium Stearoyl Glutamate, Tetrasodium Glutamate Diacetate, Silica, Xanthan Gum, Iron Oxides (CI 77492, CI 44791, CI 77499), *Organic Ingredient **Olive

🎯 Purpose 1 words ▾

Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 77394-0203-03 · Lather, 77412-0199-01 · Shandong →
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.