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Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30 Titanium Dioxide, Zinc Oxide 58 mg/mL; 125 mg/mL Lotion — NDC 69968-0813-02 package photo

Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30 Titanium Dioxide, Zinc Oxide 58 mg/mL; 125 mg/mL Lotion

by Kenvue Brands LLC · 1 TUBE in 1 CARTON (69968-0813-2) / 48 mL in 1 TUBE
NDC 69968-0813-02
🏷️ FDA NDC (as labeled) 69968-0813-2 billing pads the package segment with a zero
This package
Contains48 mL in 1 tube Pack sizes2 compare ↓
Also comes in: 12 tubes 69968-0813-01
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 Titanium Dioxide, Zinc Oxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 3, 2024 — Microbial Contamination of Non-Sterile Product (Vivier Pharma, Inc.) · FDA recall D-0662-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 69968-0813-2
Product NDC 69968-0813
11-digit billing NDC 69968081302
UNII 15FIX9V2JP, SOI2LOH54Z
UPC 0381371196203
Application # M020
SPL Set ID fbf8be03-93e2-4d7e-e053-6294a90a4fd5
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-06-01
Route TOPICAL
Dosage form LOTION
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 69968-0813-2 — 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 → 69968-0813-02. 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

LabelerKenvue Brands LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code69968
First marketedJun 2023
Product typeHuman Otc Drug
Portfolio564 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 that combines moisturizing ingredients with mineral-based sun protection. The active ingredients are titanium dioxide and zinc oxide, which are mineral UV filters commonly used in sunscreens to reflect and scatter ultraviolet light away from the skin. The product is formulated as an over-the-counter monograph drug, meaning it follows FDA's established rules for sunscreen products rather than requiring individual approval. It is designed to be applied to the skin to provide broad-spectrum sun protection with an SPF of 30.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 5QB0T2IUN0
    Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
  • UNII 58B69Q84JO
    A plant-derived emulsifier made from olive oil and fatty alcohols. It helps blend oil and water ingredients together and stabilizes the product's texture in creams, lotions, and similar formulations.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII I670DAL4SZ
    A preservative that fights bacteria and fungi. It keeps medicines and topical products stable and safe from microbial contamination during storage and use.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • UNII S3KFG6Q5X8
    An organic chemical compound used as a UV filter in topical formulations. It helps protect the medicine or product from degradation caused by sunlight exposure during storage and use.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII G7036X8B5H
    A dark iron compound that gives medicine its color. Used as a colorant in tablets and capsules to help identify the medication and make it visually distinctive.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • 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 Z6J799EAJK
    Oat is a cereal grain used in medicines as a filler and binder. It helps give the medication its shape and structure while adding bulk to the formulation.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • 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 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 MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 6GE7Z0761K
    A plant-derived ingredient from feverfew used as a natural flavoring or botanical additive in some formulations. It may contribute mild taste or aroma properties to the medicine.
  • UNII N0SS3Q238D
    A synthetic polymer made by combining povidone with long-chain fatty compounds. It acts as a binder and film-former to help hold tablet ingredients together and create smooth coatings on medicine surfaces.
  • 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.
  • UNII KFR5QEN0N9
    A synthetic plastic polymer that helps form a protective film coating on the medicine. It's used as a binder and film-former to hold the tablet or capsule together and control how quickly the drug dissolves.
  • 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.

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

The official label also statesWater, Caprylic/Capric Triglyceride, Glycerin, Ethylhexyl,Methoxycrylene, Dimethicone, Triacontanyl PVP, Glyceryl Stearate, Calcium Sodium Borosilicate, PEG-100 Stearate, Polyhydroxystearic Acid, VP/Hexadecene Copolymer, Avena Sativa (Oat) Kernel Extract, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice, Tocopheryl Acetate, Xanthan Gum, Cetearyl Olivate, Sorbitan Olivate, Stearic Acid,Triethoxycaprylylsilane, Ethylhexylglycerin, Sodium Chloride, Phenoxyethanol, Cetearyl Alcohol, Chlorphenesin, Disodium EDTA, Aluminum Hydroxide, 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 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.
Try another pack size: 12 tubes
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
Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30 58 mg/mL; 125 mg/mLthis 69968-0813-02 Kenvue 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

🏛️
2023
On the market since
Jun 2023
📍
2026
Currently FDA-listed
3 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69968-0813-01 12 TUBE in 1 TRAY (69968-0813-1) / 14 mL in 1 TUBE 2023-06-01 Active
69968-0813-02 You're viewing this 1 TUBE in 1 CARTON (69968-0813-2) / 48 mL in 1 TUBE 2023-06-01 Active

Pack size FAQ

What quantity is in NDC 69968-0813-02?
NDC 69968-0813-02 is listed by the FDA — 1 tube in 1 carton / 48 ml in 1 tube.
What NDC number is used to bill for this package of Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30 Titanium Dioxide, Zinc Oxide 58 mg/mL; 125 mg/mL Lotion?
Bill NDC 69968-0813-02 — the 11-digit billing format is 69968081302. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 69968-0813-2, 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: 69968-0813-02, written without dashes as 69968081302. 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 69968-0813-02, the first segment (69968) is the labeler code FDA assigned to Kenvue Brands LLC; the middle segment (0813) 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 Kenvue Brands LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 12 tubes (69968-0813-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Kenvue Brands LLC 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 30 words ▾

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

⏱️ Dosage and Administration 103 words ▾

Directions For sunscreen use: ▪ Apply generously and evenly 15 minutes before sun exposure ▪ Reapply at least every 2 hours ▪ Use a water resistant sunscreen if swimming or sweating ▪ 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.–2 p.m. ▪ wear long-sleeved shirts, pants, hats, and sunglasses ▪ children under 6 months of age: Ask a doctor.

⚠️ Warnings 53 words ▾

Warnings For external use only 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

📦 Storage and Handling 15 words ▾

Other information Protect this product from excessive heat and direct sun May stain some fabrics

🧪 Active Ingredient 15 words ▾

Titanium Dioxide Zinc Oxide Active ingredients Purpose Titanium Dioxide (5.8%) Sunscreen Zinc Oxide (12.5%) Sunscreen

🧪 Inactive Ingredients 54 words ▾

Inactive ingredients Water, Caprylic/Capric Triglyceride, Glycerin, Ethylhexyl,Methoxycrylene, Dimethicone, Triacontanyl PVP, Glyceryl Stearate, Calcium Sodium Borosilicate, PEG-100 Stearate, Polyhydroxystearic Acid, VP/Hexadecene Copolymer, Avena Sativa (Oat) Kernel Extract, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice, Tocopheryl Acetate, Xanthan Gum, Cetearyl Olivate, Sorbitan Olivate, Stearic Acid,Triethoxycaprylylsilane, Ethylhexylglycerin, Sodium Chloride, Phenoxyethanol, Cetearyl Alcohol, Chlorphenesin, Disodium EDTA, Aluminum Hydroxide, Iron Oxides

🎯 Purpose 11 words ▾

Active ingredients Purpose Titanium Dioxide (5.8%) Sunscreen Zinc Oxide (12.5%) Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69968-0812-01 · Kenvue 69968-0815-01 · Kenvue →
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.