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Babyganics Sheer Blend SPF50 Mineral Sunscreen Zinc Oxide 20 g/100mL Lotion, 50 mL — NDC 59062-2202-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Babyganics Sheer Blend SPF50 Mineral Sunscreen Zinc Oxide 20 g/100mL Lotion, 50 mL — NDC 59062-2202-1 (Billing 59062-2202-01)

by KAS Direct LLC dba BabyGanics · 50 mL in 1 TUBE

This is a package of 50 mL of Babyganics Sheer Blend SPF50 Mineral Sunscreen Zinc Oxide 20 g/100mL Lotion from KAS Direct LLC dba BabyGanics, marketed since Dec 2023 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 59062-2202-01
🏷️ FDA NDC (as labeled) 59062-2202-1 billing pads the package segment with a zero
This package
Contains50 mL Pack sizes3 compare ↓
Main listing for product 59062-2202 · Also comes in: 89 ml 59062-2202-3 236 ml 59062-2202-8
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 59062-2202-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
59062 labeler · 2202 product · 1 package
Package marketed since
Dec 1, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0810035921382
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) 59062-2202-1
Product NDC 59062-2202
11-digit billing NDC 59062220201
UNII SOI2LOH54Z
UPC 0810035921382
Application # M020
SPL Set ID edced0dc-dd43-4ac9-b816-f4edb45fc87b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-12-01
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 59062-2202-1 — 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 → 59062-2202-01. 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?

Babyganics Sheer Blend SPF50 is a lotion applied to the skin to help protect against ultraviolet rays from the sun. The active ingredient is zinc oxide, a mineral UV filter that sits on top of the skin and reflects sunlight away. This product is marketed as an over-the-counter sunscreen under FDA's established monograph rules for sunscreen drugs, meaning it follows a standard formula category rather than being individually reviewed by the FDA.

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.
Try another pack size: 89 ml 236 ml
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
59062-2202-01 You're viewing this Main listing 50 mL in 1 TUBE 2023-12-01 — Active
59062-2202-03 59062-2202-3 89 mL in 1 TUBE 2023-12-01 — Active
59062-2202-08 59062-2202-8 236 mL in 1 TUBE 2023-12-01 — Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 50 mL — 50 ml in 1 tube.
How does this package differ from NDC 59062-2202-03?
Both are Babyganics Sheer Blend SPF50 Mineral Sunscreen Zinc Oxide 20 g/100mL Lotion — the drug itself is identical. This page's package is the 50 mL one, while NDC 59062-2202-03 is the 89 ml package.
What NDC number is used to bill for this package of Babyganics Sheer Blend SPF50 Mineral Sunscreen Zinc Oxide 20 g/100mL Lotion?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Surface SPF 50 3oz Tinted mineral sunscreen with Water Resistance 20 g/100mL 72344-0112-03 Surface 88 ml — — FDA listed —
Solara Suncare - Clean Freak Spf-30 Naturally Scented 20 g/100mL 73054-0102-11 SOLARA 1 tube — — FDA listed —
Rio Radiance SPF 50 BodyLotion 20 g/100mL 83982-4838-00 SOL 1 tube — — FDA listed —
Thrive Daily Sunscreen For Sensitive Skin SPF 30 20 g/100mL 84138-0002-02 Thrive 1 bottle — — FDA listed —
Spf-30 Bb 20 g/100mL 69090-0100-01 ZION 110 ml — — FDA listed —
Native Mineral Sunscreen Broad Spectrum SPF 30 Unscented 20 g/100mL 69423-0550-14 The 147 ml — — Discontinued —
Solara Suncare - Fortune Teller Spf-30 20 g/100mL 73054-0120-11 SOLARA 1 tube — — FDA listed —
Babyganics Kids Sheer Blend SPF50 Mineral Sunscreen 20 g/100mL 59062-2203-03 KAS 89 ml — — FDA listed —
Sunceutical SPF 50 Mineral Body Cream 20 g/100mL 70157-0368-02 Baxter 1 jar — — FDA listed —
SPF 50 Mineral Sunscreen Face and Body 20 g/100mL 85865-0002-01 Toddle 50 ml — — FDA listed —
BOA VIDA Calvida 20 g/100mL 62654-0145-04 Central 118 ml — — FDA listed —
Sheer Mineral Sunscreen 20 g/100mL 84009-0816-01 Plant 1 tube — — FDA listed —
Native Mineral Sunscreen Broad Spectrum SPF 30 Tropical Breeze 20 g/100mL 84126-0605-14 The 147 ml — — FDA listed —
Ava Isa Sun Lip Sun Whip Strawberry Zinnia 20 g/100mL 71644-0010-10 Cyberderm 1 tube — — FDA listed —
Solara Suncare - Glow Getter Spf-30 Naturally Scented 20 g/100mL 73054-0103-11 SOLARA 1 tube — — FDA listed —
Solara Suncare - Time Traveler Spf-30 Unscented 20 g/100mL 73054-0105-11 SOLARA 1 tube — — FDA listed —
Native Mineral Suncare Daily Face Broad Spectrum SPF 30 Unscented 20 g/100mL 84126-0157-50 The 1 tube — — FDA listed —
Thrive Daily Defense Sunscreen Balm SPF30 20 g/100mL 84138-0001-02 Thrive 1 bottle — — FDA listed —
Surface Sun SPF 50 Mineral 20 g/100mL 72344-0110-03 Surface 88 ml — — FDA listed —
ARAMORE MULTI-DEFENSE SUNSCREEN - AM Broad Spectrum SPF 30 20 g/100mL 83127-0101-11 New 50 ml — — FDA listed —
Native Mineral Suncare Broad Spectrum SPF 30 Unscented 20 g/100mL 84126-0156-14 The 147 ml — — FDA listed —
Babyganics Sheer Blend SPF50 Mineral Sunscreen 20 g/100mLthis 59062-2202-01 KAS 50 ml — — FDA listed —
Native Mineral Face Broad Spectrum SPF 30 Unscented 20 g/100mL 69423-0548-50 The 50 ml — — Discontinued —
Native Facial Care Brightening Facial Moisturizer Broad Spectrum SPF 30 20 g/100mL 69423-0621-50 The 1 bottle — — FDA listed —
Native Mineral Sunscreen Broad Spectrum SPF 30 Sweet Peach and Nectar 20 g/100mL 69423-0731-14 The 147 ml — — FDA listed —
Sunceutical SPF 50 Mineral Glow Serum 20 g/100mL 70157-0367-02 Baxter 1 jar — — FDA listed —
Sunceutical SPF 50 Mineral Face Cream 20 g/100mL 70157-0369-02 Baxter 1 jar — — FDA listed —
Ava Isa Sun Lip Sun Whip Clear Sunshine 20 g/100mL 71644-0009-10 Cyberderm 1 tube — — FDA listed —
Mineral Defense Sport Antioxidant Face Sunscreen Spf-50 20 g/100mL 73054-0107-11 SOLARA 1 tube — — FDA listed —
Silk Mineral SPF 50 Sunscreen Face 20 g/100mL 70157-0026-01 Baxter 50 ml — — FDA listed —
Ava Isa Sun Lip Sun Whip Watermelon Lily 20 g/100mL 71644-0011-10 Cyberderm 1 tube — — FDA listed —
Native Daily Face Mineral Sunscreen Broad Spectrum SPF 30 Coconut and Pineapple 20 g/100mL 84126-0112-50 The 50 ml — — FDA listed —
Native Mineral Suncare Broad Spectrum SPF 30 Coconut and Pineapple 20 g/100mL 84126-0155-14 The 147 ml — — FDA listed —
Sol de Janiero Rio Radiance SPF 50 Body 20 g/100mL 66163-4838-01 Cosmetic 1 bottle — — FDA listed —
Native Mineral Face Broad Spectrum SPF 30 Coconut and Pineapple 20 g/100mL 69423-0549-50 The 50 ml — — Discontinued —
Solara Suncare - Clean Freak Spf-30 Unscented 20 g/100mL 73054-0101-11 SOLARA 1 tube — — FDA listed —
Bliss Block Star Sheer Liquid Daily Sunscreen SPF 50 SPF-50 20 g/100mL 67038-0203-60 Bliss 1 bottle — — FDA listed —
First Aid Beauty FAB Mineral Sunscreen Broad Spectrum SPF 30 20 g/100mL 69423-0622-50 The 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
Dec 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.

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 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 8TY5YO42NJ
    Capryloyl glycine is a mild, skin-conditioning ingredient made from a natural fatty acid and the amino acid glycine. In medicines, it acts as a surfactant and preservative booster, helping the product spread evenly and resist contamination.
  • 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 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 38ZFO1X2U7
    A plant-derived ingredient from cranberry seeds, used as a natural colorant and antioxidant in medicines to provide color and help preserve the product's stability during storage.
  • 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 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 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII 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 CS4U38E731
    A plant-derived oil from nigella sativa seeds, used as a carrier and emollient in formulations. It helps dissolve or suspend active ingredients and improves product texture and absorption.
  • 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 5759J47SAM
    A plant-derived emulsifier made from glycerin and oleic acid. It helps blend water and oil ingredients together in creams and lotions, keeping the product uniform and stable.
  • UNII 253MC0P0YV
    A waxy compound made from glycerin and stearic acid, used as an emulsifier to help mix oil and water-based ingredients together in the formulation.
  • 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 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 M3CL7US2ZG
    A natural plant extract from red raspberry seeds. It's used as an antioxidant and flavoring agent to help preserve the medicine and improve its taste.
  • 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 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.
  • UNII R9N3379M4Z
    Sunflower seed is a plant-derived ingredient used as a filler and source of oil in medications. It helps add bulk to the formulation and may serve as a natural binding or lubricating component.
  • UNII 7N87T9C06T
    A natural oil extracted from tomato seeds. It's used as an emollient and skin-conditioning agent in topical formulations to help soften and smooth the product's texture.
  • UNII 4D20464K2J
    A synthetic compound derived from undecylenic acid combined with the amino acid glycine. It functions as a preservative and antimicrobial agent to help prevent contamination and extend the product's shelf life.
  • 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.

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

The official label also statesbutyloctyl salicylate, butyrospermum parkii (shea) butter Certified Organic Ingredient Unless otherwise specified, product not labeled as organic., caprylic/capric triglyceride, capryloyl glycine, caprylyl glycol, coco-caprylate, cocos nucifera (coconut) oil, ethylhexylglycerin, glycerin, helianthus annuus (sunflower) seed oil, lsoamyl laurate, magnesium stearate, magnesium sulfate, nigella sativa seed oil, polyglyceryl-2 oleate, polyglyceryl-2 stearate, polyhydroxystearic acid, propanediol, rubus ldaeus (raspberry) seed oil, sodium phytate, solanum lycopersicum (tomato) seed oil, stearyl/octyldodecyl citrate crosspolymer, undecylenoyl glycine, vaccinium macrocarpon (cranberry) seed oil, water

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

LabelerKAS Direct LLC dba BabyGanics
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code59062
First marketedDec 2023
Product typeHuman Otc Drug
Portfolio17 products on file

More NDCs from KAS Direct LLC dba BabyGanics labeler code 59062

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 📦 Storage and Handling 🧪 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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 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 93 words ▾

Directions apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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.-2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses

⚠️ Warnings 54 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 swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 11 words ▾

Other information protect this product from excessive heat and direct sun

🧪 Active Ingredient 5 words ▾

Active ingredients Zinc oxide 20%

🧪 Inactive Ingredients 82 words ▾

Inactive ingredients butyloctyl salicylate, butyrospermum parkii (shea) butter Certified Organic Ingredient Unless otherwise specified, product not labeled as organic. , caprylic/capric triglyceride, capryloyl glycine, caprylyl glycol, coco-caprylate, cocos nucifera (coconut) oil , ethylhexylglycerin, glycerin , helianthus annuus (sunflower) seed oil , lsoamyl laurate, magnesium stearate, magnesium sulfate, nigella sativa seed oil , polyglyceryl-2 oleate, polyglyceryl-2 stearate, polyhydroxystearic acid, propanediol, rubus ldaeus (raspberry) seed oil, sodium phytate, solanum lycopersicum (tomato) seed oil, stearyl/octyldodecyl citrate crosspolymer, undecylenoyl glycine, vaccinium macrocarpon (cranberry) seed oil, water

🎯 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 19 words ▾

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

📄 Package Label / Principal Display Panel 69 words ▾

PRINCIPAL DISPLAY PANEL - 236 mL Tube Label non allergenic blends in & blocks out babyganics ® SHEER BLEND SPF 50 mineral sunscreen fragrance free tear free • pediatrician tested broad spectrum SPF 50 water resistant (80 minutes) made without oxybenzone, octinoxate, parabens, fragrance, nano-particles Discover which of our ingredients are Certified Organic on back panel. 8 FL OZ (236 mL) PRINCIPAL DISPLAY PANEL - 236 mL Tube Label

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 Babyganics Sheer Blend SPF50 Mineral Sunscreen (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Reporter sex

0 reports

Serious outcomes

Death204
Life-threatening116
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 196 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 ✓ 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 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 KAS Direct LLC dba BabyGanics. 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 2 other package presentations of this same product, including 89 ml (59062-2202-03), 236 ml (59062-2202-08). 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?
KAS Direct LLC dba BabyGanics 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.
← 59062-2201-04 · KAS 59062-2203-03 · KAS →
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.