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Avene Hydrance Moisturizing SPF 30 Zinc oxide 100 mg/mL Lotion

by Pierre Fabre USA Inc. · 1 TUBE in 1 CARTON (64760-783-01) / 40 mL in 1 TUBE
NDC 64760-0783-01
🏷️ FDA NDC (as labeled) 64760-783-01 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) 64760-783-01
Product NDC 64760-783
11-digit billing NDC 64760078301
UNII SOI2LOH54Z
Application # M020
SPL Set ID 1361ebe5-2659-d88f-e063-6294a90a71bb
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-04-01
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 64760-783-01 — 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 → 64760-0783-01. 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.

🏭 Manufacturer & labeler

LabelerPierre Fabre USA Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code64760
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio12 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 moisturizer with sunscreen protection marketed under the FDA's over-the-counter monograph rules. The active ingredient zinc oxide functions as a physical sunscreen agent, reflecting and scattering ultraviolet light away from the skin. The product is typically used to help protect skin from sun exposure while providing moisture to the face.

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 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 B423VGH5S9
    A natural fruit ingredient derived from apples, used as a flavoring agent and sweetener to improve taste and palatability of the medicine.
  • 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 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII 4828G836N6
    A plant-derived oil mixture from coconut that acts as an emollient and solvent. It helps dissolve or carry active ingredients and improves how the medicine spreads or absorbs in topical formulations.
  • 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 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 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 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 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • 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 N8F53B3R4R
    A synthetic humectant and solvent derived from propane. It draws and holds moisture in the formulation, helping keep the medicine stable and improving texture or flow in liquid and semi-solid products.
  • UNII 0F897O3O4M
    A naturally occurring alcohol derived from plants or synthesized chemically. It functions as a preservative and flavoring agent in medicines, helping prevent microbial growth and add pleasant taste to oral products.
  • UNII 7Q0OK5DOT4
    A plant-derived emulsifier made from glycerin and ricinoleic acid (from castor oil). It helps blend oil and water-based ingredients together in formulations and improves product texture and stability.
  • 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 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 V2CI786FPG
    A plant-derived emollient made from shea butter, used in topical formulations to soften the skin and improve texture. It helps stabilize oil and water mixtures and creates a smooth, spreadable consistency in creams and ointments.
  • 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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 A3LZF0L939
    Tridecane is a clear, colorless liquid hydrocarbon derived from petroleum. It acts as a solvent and lubricant in medicines, helping distribute active ingredients evenly and reducing friction during manufacturing and tablet compression.
  • UNII AZQ08K38Z1
    A synthetic oily liquid derived from salicylic acid. It works as an emollient and penetration enhancer in topical formulations, helping active ingredients absorb into skin while conditioning and softening the application area.
  • UNII JV0QT00NUE
    Undecane is a clear liquid hydrocarbon derived from petroleum. It functions as a solvent and processing aid in medicines, helping dissolve or suspend active ingredients and improve how the drug is manufactured and delivered.
  • 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.

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

The official label also statesWater, Tridecyl Salicylate, Caprylic/Capric Triglyceride, Shea Butter Ethyl Esters, Propanediol, Coco-Caprylate, C13-15 Alkane, Glycerin, Undecane, Methylpropanediol, Polyglyceryl-3 Polyricinoleate, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Disteardimonium Hectorite, Isoamyl Laurate, Silica, Tridecane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Caprylyl Glycol, Bisabolol, Allantoin, Lecithin, Aloe Barbadensis Leaf Juice Powder, Phenylpropanol, Tetrasodium Glutamate Diacetate, Tocopherol, Sodium Hydroxide.

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
Dr. Perrys Day Thyme SPF 20 Broad Spectrum Sunscreen 100 mg/mL 14268-0017-00 Englewood 1 bottle — — FDA listed —
e.l.f Sun Boss Gloss SPF 25 Sunscreen Blush Much 100 mg/mL 76354-0127-01 e.l.f. 1 tube — — FDA listed —
elf Sun Boss Gloss SPF 25 Sunscreen Peachy Kween 100 mg/mL 76354-0134-01 e.l.f. 1 tube — — FDA listed —
pavise Lip Defense tinted hydrating oil (hue 604) 100 mg/mL 83100-1761-02 B.A.I. 1 bottle — — FDA listed —
pavise Lip Defense tinted hydrating oil (hue 774) 100 mg/mL 83100-1763-02 B.A.I. 1 bottle — — FDA listed —
Avene Cleanance Mattifying SPF 30 100 mg/mL 64760-0786-01 Pierre 1 tube — — Discontinued —
Ghosted 100 mg/mL 85385-0246-01 Spooge 1 tube — — FDA listed —
Bright as Day Mineral SPF50 100 mg/mL 84130-0005-03 Koco 8 ml — — FDA listed —
Avene Hydrance Moisturizing SPF 30 100 mg/mLthis 64760-0783-01 Pierre 1 tube — — FDA listed —
Tatcha The Silk Sunscreen 100 mg/mL 69417-0130-05 TATCHA 1 bottle — — FDA listed —
e l f Sun Boss Gloss SPF 25 Sunscreen Its your Mauve 100 mg/mL 76354-0129-01 e.l.f. 1 tube — — FDA listed —
e.l.f Sun Boss Gloss SPF 25 Sunscreen Thats my Jam 100 mg/mL 76354-0128-01 e.l.f. 1 tube — — FDA listed —
Naturium Dew Glow Moisturizer Mineral SPF 50 100 mg/mL 76354-0300-01 e.l.f. 1 tube — — FDA listed —
Colorescience Total Protection No Show Mineral Body Shield 100 mg/mL 68078-0892-02 Colorescience 1 tube — — FDA listed —
Colorescience Total Protection Body Shield Glow 100 mg/mL 68078-0893-02 Colorescience 1 tube — — FDA listed —
Mental Skin Care Lip Shield Intent 100 mg/mL 82696-4440-02 Mental 1 bottle — — FDA listed —
pavise Lip Defense tinted hydrating oil (hue 616) 100 mg/mL 83100-1762-02 B.A.I. 1 bottle — — FDA listed —
elf Sun Boss Gloss SPF 25 Sunscreen Pink Me Girl 100 mg/mL 76354-0126-01 e.l.f. 1 tube — — 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

🏛️
2024
On the market since
Apr 2024
📍
2026
Currently FDA-listed
2 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 Avene Hydrance Moisturizing SPF 30 (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

0 reports

Serious outcomes

Hospitalization988
Death204
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 272 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
64760-0783-01 You're viewing this 1 TUBE in 1 CARTON (64760-783-01) / 40 mL in 1 TUBE 2024-04-01 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 — 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 FDA registers it as 64760-783-01, 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: 64760-0783-01, written without dashes as 64760078301. 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 64760-0783-01, the first segment (64760) is the labeler code FDA assigned to Pierre Fabre USA Inc.; the middle segment (0783) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Pierre Fabre USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pierre Fabre USA 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 5 words ▾

Uses • helps prevent sunburn.

⏱️ Dosage and Administration 109 words ▾

Directions Adults and children 6 months and older: • Apply generously 15 minutes before sun exposure • Reapply: • at least every 2 hours • Use a water resistant sunscreen if swimming or sweating • Children under 6 months of age: Ask a doctor • 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 value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. to 2 p.m. • Wear long-sleeve shirts, pants, hats, and sunglasses.

⚠️ Warnings 5 words ▾

Warnings For external use only.

🧪 Active Ingredient 5 words ▾

Active ingredient Zinc oxide 10%

🧪 Inactive Ingredients 52 words ▾

Inactive Ingredients Water, Tridecyl Salicylate, Caprylic/Capric Triglyceride, Shea Butter Ethyl Esters, Propanediol, Coco-Caprylate, C13-15 Alkane, Glycerin, Undecane, Methylpropanediol, Polyglyceryl-3 Polyricinoleate, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Disteardimonium Hectorite, Isoamyl Laurate, Silica, Tridecane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Caprylyl Glycol, Bisabolol, Allantoin, Lecithin, Aloe Barbadensis Leaf Juice Powder, Phenylpropanol, Tetrasodium Glutamate Diacetate, Tocopherol, Sodium Hydroxide.

🎯 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 ↗
← 64760-0782-01 · Pierre 64760-0784-01 · Pierre →
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.