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SPF 50 Mineral Sunscreen Face and Body Zinc Oxide 20 g/100mL Lotion, 100 mL — NDC 85865-0002-02 package photo

SPF 50 Mineral Sunscreen Face and Body Zinc Oxide 20 g/100mL Lotion, 100 mL

by Toddle Born Wild, Inc. · 100 mL in 1 TUBE (85865-002-02)
NDC 85865-0002-02
🏷️ FDA NDC (as labeled) 85865-002-02 billing pads the product segment with a zero
This package
Contains100 mL Pack sizes3 compare ↓
Also comes in: 50 ml 85865-0002-01 177 ml 85865-0002-03
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 85865-002-02
Product NDC 85865-002
11-digit billing NDC 85865000202
UNII SOI2LOH54Z
Application # M020
SPL Set ID e97d82fe-cd45-43a5-9c1f-3900025240a1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-10
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 85865-002-02 — 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 → 85865-0002-02. 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

LabelerToddle Born Wild, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code85865
First marketedDec 2025
Product typeHuman Otc Drug
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 mineral sunscreen lotion applied to the skin to help protect against sun damage. It contains zinc oxide, an inorganic UV filter that sits on top of the skin and reflects ultraviolet rays away from the surface. Products in this category are marketed as over-the-counter drugs under FDA's sunscreen rule, which sets standards for strength, labeling, and safety. This particular formulation provides SPF 50 protection and is intended for use on both the face and body.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (3 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 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 RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • 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 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 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 609A3V1SUA
    A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
  • 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 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 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII ZF94AP8MEY
    Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
  • UNII JOS53KRJ01
    Inulin is a fiber derived from plants like chicory root. It acts as a filler and binder in medicines to add bulk and help hold tablets together.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • 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 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 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 7Q0OK5DOT4
    A plant-derived emulsifier made from glycerin and ricinoleic acid (from castor oil). It helps blend oil and water-based ingredients together in formulations and improves product texture and stability.
  • UNII 8KQ7I65XZE
    A waxy compound derived from stearic acid, used as a thickener and emulsifier to help blend oil and water-based ingredients. It improves the texture and stability of the medicine formulation.
  • UNII 06XEA2VD56
    Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
  • 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 08MNR5YE2R
    A wax made in a laboratory to mimic natural beeswax. It's used as a coating, binder, and thickener to give medicines a smooth texture and protect them from moisture.
  • 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.

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

The official label also statesAloe Barbadensis Leaf Juice Butylene Glycol Butyloctyl Salicylate Caprylic/Capric Triglyceride Cetearyl Olivate Dicaprylyl Carbonate Dimethicone Ethylhexyl Methoxycrylene Ethylhexylglycerin Helianthus Annuus (Sunflower) Seed Oil Hydrogenated Castor Oil Inulin Isopropyl Myristate Magnesium Sulfate Niacinamide Phenoxyethanol Polyglyceryl-3 Polyricinoleate Polyhydroxystearic Acid Sorbitan Oleate Sorbitan Olivate Synthetic Beeswax Tocopheryl Acetate VP/Hexadecene Copolymer Water 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.

💲 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: 50 ml 177 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.

🔁 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/100mLthis 85865-0002-02 Toddle 100 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/100mL 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 — — FDA listed —
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

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year 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 SPF 50 Mineral Sunscreen Face and Body (this brand).

Top reported reactions

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

Age at onset

Neonate5
Infant8
Child28
Adolescent5
Adult110
Elderly192

Reporter sex

1,941 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization988
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85865-0002-01 50 mL in 1 TUBE (85865-002-01) 2025-12-10 Active
85865-0002-02 You're viewing this 100 mL in 1 TUBE (85865-002-02) 2026-02-10 Active
85865-0002-03 177 mL in 1 PACKAGE (85865-002-03) 2025-12-10 Active

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

Pack size FAQ

What quantity is in NDC 85865-0002-02?
NDC 85865-0002-02 contains 100 mL — 100 ml in 1 tube.
What is the difference between NDC 85865-0002-02 and NDC 85865-0002-01?
Both are SPF 50 Mineral Sunscreen Face and Body Zinc Oxide 20 g/100mL Lotion — the drug itself is identical. NDC 85865-0002-02 is the 100 mL package, while NDC 85865-0002-01 is the 50 ml package.
What NDC number is used to bill for this package of SPF 50 Mineral Sunscreen Face and Body Zinc Oxide 20 g/100mL Lotion?
Bill NDC 85865-0002-02 — the 11-digit billing format is 85865000202. 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 85865-002-02, 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: 85865-0002-02, written without dashes as 85865000202. 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 85865-0002-02, the first segment (85865) is the labeler code FDA assigned to Toddle Born Wild, Inc.; the middle segment (0002) 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 Toddle Born Wild, Inc.. 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 50 ml (85865-0002-01), 177 ml (85865-0002-03). 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?
Toddle Born Wild, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 28 words ▾

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 94 words ▾

Apply evenly to face and neck 15 minutes beofre 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 including: Limin time in the sun, especially from 10a.m - 2p.m Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.

⚠️ Warnings 4 words ▾

For external use only

🧪 Active Ingredient 3 words ▾

Zinc Oxide 20.00%

🧪 Inactive Ingredients 50 words ▾

Aloe Barbadensis Leaf Juice Butylene Glycol Butyloctyl Salicylate Caprylic/Capric Triglyceride Cetearyl Olivate Dicaprylyl Carbonate Dimethicone Ethylhexyl Methoxycrylene Ethylhexylglycerin Helianthus Annuus (Sunflower) Seed Oil Hydrogenated Castor Oil Inulin Isopropyl Myristate Magnesium Sulfate Niacinamide Phenoxyethanol Polyglyceryl-3 Polyricinoleate Polyhydroxystearic Acid Sorbitan Oleate Sorbitan Olivate Synthetic Beeswax Tocopheryl Acetate VP/Hexadecene Copolymer Water Xanthan Gum

🎯 Purpose 1 words ▾

Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85863-0208-50 · Eco 85866-0223-04 · Orca →
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.