FRE Glow ME Lightweight Tinted Moisturizer Zinc Oxide 24 g/100mL Cream
by Peer Pharm Ltd · 1 BOTTLE, PUMP in 1 CARTON (69435-1407-1) / 50 mL in 1 BOTTLE, PUMP
NDC 69435-1407-01
🏷️ FDA NDC (as labeled)
69435-1407-1
billing pads the package 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 →
⚠️
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)
69435-1407-1
Product NDC
69435-1407
11-digit billing NDC
69435140701
UNII
SOI2LOH54Z
Application #
M020
SPL Set ID
1cf5b24a-e6fd-470a-e063-6294a90ab29c
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2024-08-01
Route
TOPICAL
Dosage form
CREAM
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 69435-1407-1 — 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 → 69435-1407-01. 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
LabelerPeer Pharm Ltd
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code69435
First marketedAug 2024
Product typeHuman Otc Drug
Portfolio2 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 lightweight tinted moisturizing cream applied to the skin that contains zinc oxide as its active ingredient. Zinc oxide is commonly used in topical products as a physical sunscreen agent that reflects and scatters ultraviolet light away from the skin. This product is marketed as an over-the-counter drug under the FDA's monograph system for sunscreen products, meaning it follows established safety and effectiveness standards for that category rather than undergoing individual FDA review.
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 4V59G5UW9X
Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
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UNII 51XV5WTF7E
A plant extract from the argan tree's leaves. Used in topical products as a conditioning agent and emollient to help soften and smooth skin or hair.
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UNII 83K6O4FR76
A plant extract from the argan tree, native to Morocco. Used in formulations as a conditioning agent and emollient to help soften and smooth the product's texture.
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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.
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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.
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UNII 8HO6PVN24W
Carnosine is a naturally occurring compound made from two amino acids. In medicines, it may serve as a buffer to help maintain the product's pH stability.
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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 UP0M8M3VZW
A fragrant essential oil extracted from lemongrass plants, used primarily as a flavoring and fragrance agent to improve taste and aroma in oral medications.
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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.
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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.
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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.
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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 NLE5KIG74K
A plant-based oily substance made from glycerin and citric acid. It helps keep oil and water mixed together in the medicine and may aid in dissolving or delivering active ingredients.
-
UNII S870P55O2W
Isomalt is a sugar alcohol made from sugar that's used as a sweetener and bulking agent in medicines. It helps give tablets and powders the right texture and sweetness while having minimal calories.
-
UNII 113171Q70B
Lauroyl lysine is a compound made by combining an amino acid (lysine) with a fatty acid (lauric acid). It works as a glidant and lubricant to help powder particles flow smoothly during manufacturing and tablet compression.
-
UNII 76LN7P7UCU
Lauryl glucoside is a mild plant-based cleansing agent made from coconut oil and glucose. It's used in medicines as a surfactant to help dissolve and distribute ingredients evenly throughout the formulation.
-
UNII ZBP1YXW0H8
A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
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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.
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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 6AK28695LF
A plant-derived surfactant made from myristic acid and glucose. It helps dissolve or suspend other ingredients and improves how the medicine spreads or absorbs in the body.
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UNII WV9CM0O67Z
Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
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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 Q48X4BL3TV
A synthetic emulsifier made from plant-derived glycerin and lauric acid. It helps blend oil and water-based ingredients together in creams and lotions for smooth, uniform 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.
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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 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.
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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.
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UNII LDC331P08E
A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
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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.
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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.
30 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesWater, Coco-Caprylate, Glyceryl Oleate Citrate, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopherol, Argania Spinosa Kernel Oil, Polyhydroxystearic Acid, Panthenol, Triethoxycaprylylsilane, Lauryl Glucoside, Polyglyceryl-6 Laurate, Propanediol, Xanthan Gum, Myristyl Glucoside, Caprylic/Capric Triglyceride, Isomalt, Glycerin, Caprylyl Glycol, Lauroyl Lysine, Sodium Phytate, Argania Spinosa Leaf Extract, Caprylhydroxamic Acid, Cymbopogon Flexuosus Oil, Lavandula Angustifolia (Lavender) Oil, Carnosine, Argania Spinosa Callus Culture Extract, Lecithin, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).
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
🏛️
2024
On the market since
Aug 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 Zinc Oxide — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 36%
Female · 64%
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 |
|---|---|---|---|
| 69435-1407-01 You're viewing this | 1 BOTTLE, PUMP in 1 CARTON (69435-1407-1) / 50 mL in 1 BOTTLE, PUMP | 2024-08-01 | 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 69435-1407-1, 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: 69435-1407-01, written without dashes as 69435140701. 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 69435-1407-01, the first segment (69435) is the labeler code FDA assigned to Peer Pharm Ltd; the middle segment (1407) 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 Peer Pharm Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Peer Pharm Ltd 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
📦 Storage and Handling
🧪 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 • Shake well before use. • Apply liberally 15 minutes before sun exposure. • Reapply: • After 40 minutes of swimming or sweating. • Immediately after towel drying. • 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 value of 15 or higher and other sun protection measures. • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses. • For children under 6 months of age: 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 a doctor if rash occurs. • If swallowed, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information Protect the product in this container from excessive heat and direct sun. Do not use if the seal is broken.
🧪 Active Ingredient ▾
Drug Facts Active Ingredient: Zinc Oxide 24.0%
🧪 Inactive Ingredients ▾
Inactive Ingredients Water, Coco-Caprylate, Glyceryl Oleate Citrate, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopherol, Argania Spinosa Kernel Oil, Polyhydroxystearic Acid, Panthenol, Triethoxycaprylylsilane, Lauryl Glucoside, Polyglyceryl-6 Laurate, Propanediol, Xanthan Gum, Myristyl Glucoside, Caprylic/Capric Triglyceride, Isomalt, Glycerin, Caprylyl Glycol, Lauroyl Lysine, Sodium Phytate, Argania Spinosa Leaf Extract, Caprylhydroxamic Acid, Cymbopogon Flexuosus Oil, Lavandula Angustifolia (Lavender) Oil, Carnosine, Argania Spinosa Callus Culture Extract, Lecithin, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).
🎯 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.