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Cancer Council Mineral Fluid SPF50 Zinc Oxide 150 mg/mL Lotion — NDC 84258-006-01 (Billing 84258-0006-01)

by Vitality US Co. · 1 TUBE in 1 CARTON / 50 mL in 1 TUBE

This is a package of Cancer Council Mineral Fluid SPF50 Zinc Oxide 150 mg/mL Lotion from Vitality US Co., marketed since Sep 2024 and currently FDA-listed. It is this product's only package size.

NDC 84258-0006-01
🏷️ FDA NDC (as labeled) 84258-006-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 84258-006-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84258 labeler · 006 product · 01 package
Package marketed since
Sep 30, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8425800601 5
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84258-006-01
Product NDC 84258-006
11-digit billing NDC 84258000601
UNII SOI2LOH54Z
Application # M020
SPL Set ID 1638f8a4-a2da-4e1f-e063-6294a90a03d9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-30
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 84258-006-01 — 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 → 84258-0006-01. 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.

Clinical

🧪 What is this product?

This is a topical lotion sunscreen marketed as an over-the-counter monograph product. It contains zinc oxide, a mineral UV filter that functions as a broad-spectrum sunscreen agent. Zinc oxide is typically used in sun protection products to help block ultraviolet radiation from reaching the skin. This lotion formulation is designed to be applied to the skin surface for sun protection purposes.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
84258-0006-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 50 mL in 1 TUBE 2024-09-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Proven Personalized Day Moisturizer With SPF 50 150 mg/mL 73572-0004-30 Proven 30 ml — — FDA listed —
MIAMI BEACH BUM Save Face SPF-30 Sunscreen 150 mg/mL 82812-0336-00 MIAMI 100 ml — — FDA listed —
MIAMI BEACH BUM Blocked SPF-30 Sunscreen 150 mg/mL 82812-0337-00 MIAMI 180 ml — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Tinted Moisturizer 150 mg/mL 90086-0012-01 Clean 40 ml — — FDA listed —
SEAWEED BATH CO Everyday Mineral SPF 40 150 mg/mL 81159-0259-00 The 100 ml — — FDA listed —
Miami Beach Bum SPF 30 Bodyguard Face Body Mineral Sunscreen 150 mg/mL 82812-0958-00 Miami 100 ml — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four 150 mg/mL 90086-0017-01 Clean 1 tube — — FDA listed —
Sqween Paint-On Sun Protection for Independent Kids Mineral Sunscreen SPF 30 150 mg/mL 83005-0002-01 Sqween 118 ml — — FDA listed —
ETADERM Tattoo Sunscreen Broad Spectrum SPF-30 150 mg/mL 84180-0472-00 NUEPHASE 118 ml — — FDA listed —
Oathology Inzincable Lip Balm SPF 35 150 mg/mL 85562-0694-00 SKINOATH 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three and Half 150 mg/mL 90086-0016-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five 150 mg/mL 90086-0019-01 Clean 1 tube — — FDA listed —
Sun Bum Daily Mineral Sunscreen Moisturizer Broad Spectrum SPF 30 150 mg/mL 69039-0761-02 Sun 1 bottle — — FDA listed —
Saie Sunvisor Broad Spectrum SPF 35 Sheer Moisturizer 150 mg/mL 90086-0011-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four and Half 150 mg/mL 90086-0018-01 Clean 1 tube — — FDA listed —
Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen 150 mg/mL 64657-0007-02 Naturopathica 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three 150 mg/mL 90086-0015-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine 150 mg/mL 90086-0024-01 Clean 1 tube — — FDA listed —
Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water Resistant 150 mg/mL 83005-0001-01 SQWEEN 60 ml — — FDA listed —
Good Weather Skin The One Daily Sun Warm Glow SPF 30 150 mg/mL 85090-0002-01 Good 1 bottle — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine and Half 150 mg/mL 90086-0025-01 Clean 1 tube — — FDA listed —
Lion Pose Ghost-Buster Broad Spectrum Spf 42 Sunscreen 150 mg/mL 83605-0001-01 Lion 2 ml — — Discontinued —
Cancer Council Mineral Fluid SPF50 150 mg/mLthis 84258-0006-01 Vitality 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade One 150 mg/mL 90086-0013-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer ShadeTwo 150 mg/mL 90086-0014-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Eight 150 mg/mL 90086-0023-01 Clean 1 tube — — FDA listed —
Duke Cannon Supply Co. Daily Defense Face Mineral Sunscreen Broad Spectrum SPF 32 150 mg/mL 71782-0201-03 DUKE 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Ten 150 mg/mL 90086-0026-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five and Half 150 mg/mL 90086-0020-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Six 150 mg/mL 90086-0021-01 Clean 1 tube — — FDA listed —
Lion Pose Unghosted Tinted Mineral Spf 42 Uva Uvb Sunscreen 150 mg/mL 83605-0002-01 Lion 1 bottle — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Seven 150 mg/mL 90086-0022-01 Clean 1 tube — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Light Green 150 mg/mL 83005-0005-01 Sqween 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Blue 150 mg/mL 83005-0003-01 Sqween 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Blue 150 mg/mL 58419-0011-00 Atlantis 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Pink 150 mg/mL 83005-0006-01 Sqween 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Gold 150 mg/mL 83005-0004-01 Sqween 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Rose Gold 150 mg/mL 83005-0007-01 Sqween 60 ml — — 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
Sep 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.

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 77MKL7AR5I
    A natural oil extracted from baobab tree seeds. It's used as an emollient and skin-conditioning agent to help soften the product texture and improve how the medicine feels on application.
  • 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 PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII 2EH13UN8D3
    A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
  • UNII P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII Z17H97EA6Y
    A plant-derived mild cleanser made from natural sugars and oils. It acts as an emulsifier and surfactant to help mix water and oil-based ingredients together in the medicine.
  • UNII 11A386X1QH
    Dodecane is a clear, colorless liquid hydrocarbon derived from petroleum. It functions as a solvent and lubricant in medicines, helping dissolve active ingredients and improve how the product flows during manufacturing.
  • 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 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 B68LJT9544
    A fatty acid derivative used as a preservative and antimicrobial agent in topical medicines. It helps prevent bacterial and fungal growth to maintain product stability and safety.
  • UNII TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • 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 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII 6M3P64V0NC
    A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
  • 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 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII 56687D1Z4D
    A natural plant extract from pomegranate fruit, used as a flavor and color ingredient to enhance taste and appearance in medicines.
  • 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 W8K377W98I
    A mixture of sugars made by rearranging glucose molecules. It acts as a sweetener and filler to improve taste and add bulk to the medicine while helping it hold together.
  • UNII X6JU3FX5UU
    A salt derived from citric acid, sodium citrate monohydrate acts as a buffer in medicines to stabilize pH and prevent ingredient breakdown. It may also help improve taste and texture.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • 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 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 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.
  • UNII 44FQ49X6UN
    A polysaccharide (complex carbohydrate) derived from yeast cell walls. In medicines, it acts as a binder to hold tablet ingredients together and may help with tablet structure and stability.

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

The official label also statesAdansonia Digitata (Baobab) Oil, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Ascorbic Acid (Vitamin C), Betaglucan, Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Citric Acid, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Caprylate, Glyceryl Stearate SE, Glyceryl Undecylenate, Iron Oxides (Black, Red, Yellow), Magnesium Aluminum Silicate, Methyl Dihydroabietate, Niacinamide, Polysorbate 20, Propanediol, Punica Granatum (Pomegranate) Fruit Extract, Saccharide Isomerate, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Citrate, Sodium Hyaluronate, Squalane, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Water (Aqua), Xanthan Gum

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.

Manufacturer & labeler

LabelerVitality US Co.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84258
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio6 products on file

More NDCs from Vitality US Co. labeler code 84258

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.

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 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 101 words ▾

Directions apply liberally 15 minutes before sun exposure apply to all skin exposed to the sun reapply: after 80 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 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 56 words ▾

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 Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredients Zinc Oxide 15%

🧪 Inactive Ingredients 90 words ▾

Inactive ingredients Adansonia Digitata (Baobab) Oil, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Ascorbic Acid (Vitamin C), Betaglucan, Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Citric Acid, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Caprylate, Glyceryl Stearate SE, Glyceryl Undecylenate, Iron Oxides (Black, Red, Yellow), Magnesium Aluminum Silicate, Methyl Dihydroabietate, Niacinamide, Polysorbate 20, Propanediol, Punica Granatum (Pomegranate) Fruit Extract, Saccharide Isomerate, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Citrate, Sodium Hyaluronate, Squalane, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Water (Aqua), Xanthan Gum

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin

📄 When Using This Product 13 words ▾

When using this product keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if rash occurs

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

📄 Other Information 11 words ▾

Other information protect this product from excessive heat and direct sun

📄 Questions or Comments 4 words ▾

Questions or comments? [email protected]

📄 Package Label / Principal Display Panel 3 words ▾

Product Packaging 1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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

Macular Degeneration460
Nausea365
Pyrexia351
Pain348
Malaise289
Weight Decreased284
Constipation256

Age at onset

Neonate6
Infant11
Child35
Adolescent8
Adult218
Elderly272

Reporter sex

3,195 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization1,367
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 365 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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Vitality US Co.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Vitality US Co. 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.
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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.