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THERA Calazinc Body Shield Zinc Oxide 200 mg/g Paste — NDC 68599-0205-01 package photo

THERA Calazinc Body Shield Zinc Oxide 200 mg/g Paste

by McKesson Medical-Surgical Inc. · 144 PACKET in 1 CARTON (68599-0205-1) / 4 g in 1 PACKET
NDC 68599-0205-01
🏷️ FDA NDC (as labeled) 68599-0205-1 billing pads the package segment with a zero
This package
Contains4 g in 1 packet Pack sizes2 compare ↓
Also comes in: 113 g 68599-0205-04
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) 68599-0205-1
Product NDC 68599-0205
11-digit billing NDC 68599020501
UNII SOI2LOH54Z
Application # M016
SPL Set ID 974b1046-83ee-4207-91d3-40982beb9c63
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-09-01
Route TOPICAL
Dosage form PASTE
Substance ZINC OXIDE
GCN Seq No 086604
GCN 56338
HICL code 002304
Ingredient (HICL) Calamine/Zinc Oxide
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L3
Therapeutic class — intermediate (HIC2) Protectives
HIC3 code L3A
Therapeutic class — specific (HIC3) Protectives
AHFS code 84:24.12.00
AHFS class Basic Ointments And Protectants
FDB label name THERA CALAZINC 20% BODY SHIELD
FDB brand name Thera Calazinc
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 68599-0205-1 — 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 → 68599-0205-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerMcKesson Medical-Surgical Inc.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code68599
First marketedSep 2011
Product typeHuman Otc Drug
Portfolio16 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

Label name THERA CALAZINC 20% BODY SHIELD Ingredient Calamine/Zinc Oxide
🧪 What is this product?

This is a topical paste containing zinc oxide, marketed as an over-the-counter monograph product. Zinc oxide is commonly used in skin-care products as a barrier agent and mild astringent, typically applied to the skin to help protect and soothe minor irritation. The paste form allows for direct application to affected areas. This product is regulated under the FDA's OTC monograph rules for its category rather than as an individually approved application.

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 WR1WPI7EW8
    A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
  • UNII OF5P57N2ZX
    Alanine is a naturally occurring amino acid used in medicines as a buffering agent and pH stabilizer. It helps maintain the proper acidity level in liquid formulations to improve stability and taste.
  • 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 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
  • UNII 30KYC7MIAI
    Aspartic acid is an amino acid used in pharmaceutical formulations as a pH buffer and to help stabilize active ingredients. It works to maintain the proper acidity level in the medicine.
  • 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 568ET80C3D
    Calcium pantothenate is a salt form of pantothenic acid, a B-vitamin derivative. It's used as a nutritional supplement or vitamin fortification ingredient in medicines and formulations.
  • 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 9S60Q72309
    A plant-derived ingredient made from safflower seed components. It acts as an emulsifier and carrier to help distribute oils and active ingredients evenly throughout the medicine.
  • 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 C5529G5JPQ
    Ginger is a plant-derived ingredient used as a flavoring agent to add taste and aroma to medicines. It may also provide mild soothing properties to support product palatability.
  • UNII 3KX376GY7L
    Glutamic acid is an amino acid used in pharmaceuticals as a buffer and pH regulator. It helps maintain the medicine's chemical stability and proper acidity level.
  • UNII TE7660XO1C
    Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
  • UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • 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 04Y7590D77
    A naturally occurring amino acid used as a buffering agent and pH stabilizer in medications. It helps maintain the chemical balance of the formulation to protect drug stability.
  • UNII TP11QR7B8R
    A natural oil extracted from kukui nuts, used as an emollient and skin-conditioning agent in topical medicines. It helps soften the formulation and improve how the product spreads and absorbs into skin.
  • UNII GMW67QNF9C
    Leucine is an amino acid derived from natural sources. It acts as a glidant and flow agent in powders and tablets, helping the medicine move smoothly during manufacturing and packaging.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII K3Z4F929H6
    Lysine is an amino acid that serves as a buffer and pH regulator in medications. It helps maintain the medicine's stability and proper acidity level during storage and use.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • 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 12UZE4X73L
    A modified starch derived by chemically treating regular starch with succinic acid. It acts as a thickener, stabilizer, and emulsifier to improve texture and prevent separation in liquid or semi-solid formulations.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII 47E5O17Y3R
    Phenylalanine is an amino acid used as a sweetener and flavor enhancer in medicines and supplements. It helps make products taste better while keeping them shelf-stable.
  • UNII 9DLQ4CIU6V
    Proline is an amino acid used in pharmaceutical formulations as a bulking agent and stabilizer. It helps maintain product stability and can improve the texture or consistency of medicines, particularly in powders and freeze-dried products.
  • UNII 68Y4CF58BV
    Pyridoxine hydrochloride is a form of vitamin B6, added to medicines as a nutritional supplement or to meet dietary requirements. It supports the body's metabolism and nerve function.
  • UNII 65UEH262IS
    Safflower oil is a plant-based oil extracted from safflower seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and sometimes as an emollient to improve texture.
  • UNII 452VLY9402
    Serine is an amino acid, a building block of proteins. In medications, it functions as a buffering agent and stabilizer to help maintain the product's pH balance and protect active ingredients during storage.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 2ZD004190S
    Threonine is an amino acid, a naturally occurring protein building block. It functions as a buffering agent and pH stabilizer in medicines to maintain proper acidity levels and product stability.
  • UNII 42HK56048U
    Tyrosine is an amino acid, a building block of proteins. In medicines, it's used as a buffering agent to help stabilize the product's pH and improve its chemical stability during storage.
  • UNII HG18B9YRS7
    Valine is an amino acid, one of the building blocks of proteins. In medicines, it acts as a filler and bulking agent to give the product proper volume and texture.
  • 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 1G5HNE09V8
    A plant-based ingredient derived from whole corn. It serves as a filler and binder to add bulk and help hold the tablet or capsule together during manufacturing.
  • UNII EQR32Y7H0M
    Zinc carbonate is an inorganic mineral compound. It's used in medicines as a buffer and absorbent to help maintain pH balance and control moisture in solid dosage forms.

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

The official label also statesAleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, SAFFLEX TM (Consisting of: Calcium Pantothenate (Vitamin B 5), Maltodexdrin, Niacinamide (Vitamin B 3), Pyridoxine HCl (Vitamin B 6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E)), Bisabolol, Carthamus Tinctorius (Safflower) Olesomes, Carthamus Tinctorius (Safflower) Seed Oil, Lavender Ylang Fragrance, Modified Corn Starch, Pentaerythrityl Tetra-di-t-Butyl Hydroxyhydrocinnamate, Petrolatum, Phenoxyethanol, Sodium Hyaluronate, Zingiber Officinale (Ginger) Root Extract.

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: 113 g
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
Leader Zinc Oxide 200 mg/g 70000-0334-01 Cardinal 454 g $0.016 — Availability likely —
Nivagen Zinc Oxide 200 mg/g 75834-0170-01 Nivagen 28.4 g $0.107 — Availability likely —
Sheffield Zinc Oxide 200 mg/g 11527-0065-34 Sheffield 1 tube — — FDA listed —
Mineral Body Sunscreen Unscented 200 mg/g 69949-0111-01 Synchronicity 85 g — — FDA listed —
Shunly Zn20 Light Moisturizer 200 mg/g 81381-0205-04 Shunly 113 g — — FDA listed —
Zinc Oxide Pharma 200 mg/g 84387-0001-01 ALLIED 56.6 g — — FDA listed —
Skin Tone Defender 20% Zinc Oxide 200 mg/g 85298-0205-04 Cali 115 g — — FDA listed —
Protect 20 Zinc Oxide Mineral Sunscreen Tinted 200 mg/g 85314-0204-60 Melinda 60 g — — FDA listed —
Protect 20 Zinc Oxide Mineral Sunscreen Non-Tinted 200 mg/g 85314-0205-04 Melinda 113 g — — FDA listed —
Sol Purpose Mineral Sunscreen Tinted 200 mg/g 85317-0204-60 TRU 60 g — — FDA listed —
Sheer Mineral Sunscreen Satin Dewy Finish 200 mg/g 85317-0205-04 TRU 113 g — — FDA listed —
Covered 200 mg/g 85319-0205-15 Potency 1.5 g — — FDA listed —
SPF 40 Broad Spectrum Non-Tinted 200 mg/g 85339-0205-04 Teton 113 g — — FDA listed —
Hydrating Mineral Zinc Oxide SPF 40 200 mg/g 85360-0205-04 Spalina 113 g — — FDA listed —
Glass Skin Sunscreen Tinted 200 mg/g 85428-0204-15 Fleur 1.5 g — — FDA listed —
Hiya Kids SPF 40 Mineral Sunscren 200 mg/g 85447-0001-01 Hiya 65 g — — FDA listed —
Non Tinted Mineral Sunscreen 200 mg/g 85460-0205-04 Micro 113 g — — FDA listed —
ProtectME Tinted Mineral SPF 40 20% 200 mg/g 85470-0204-60 PUREFECTION 60 g — — FDA listed —
Skin Filter Glow SPF 200 mg/g 85496-0204-60 MALORIE 60 g — — FDA listed —
Chem-Free Sunscreen Non-Tinted Formula 200 mg/g 85507-0205-04 IT 113 g — — FDA listed —
Simply Zinc Mineral Sunscreen Tinted 200 mg/g 85519-0204-60 SKIN 60 g — — FDA listed —
Gentle Defense Sunscreen 200 mg/g 85533-0205-15 Mint 1.5 g — — FDA listed —
Moisturizing Mineral Sunscreen Tinted 200 mg/g 85558-0204-60 LOTUS 60 g — — FDA listed —
Sacred Aura 200 mg/g 85583-0205-04 IRIA 113 g — — FDA listed —
Mineral Sunscreen 200 mg/g 85645-0205-15 LEILANI 1.5 g — — FDA listed —
Non Tinted Mineral Sunscreen 20Percent Zinc Oxide 200 mg/g 85672-0205-04 JKH 113 g — — FDA listed —
Mineral Sunscreen Tinted Zinc Oxide 200 mg/g 85727-0204-60 KS 60 g — — FDA listed —
Stay Shady Non-Tinted Mineral Sunscreen 200 mg/g 85969-0205-15 AMOIE 1.5 g — — FDA listed —
Critic Aid Skin 200 mg/g 11701-0050-32 Coloplast 170 g — — FDA listed —
CoTZ Kids 200 mg/g 58892-0619-05 Fallien 5 g — — FDA listed —
THERA Calazinc Body Shield 200 mg/gthis 68599-0205-01 McKesson 144 packets — — FDA listed —
NATURAL MOISTURIZING FACE SUNSCREEN and PRIMER 200 mg/g 69949-0010-01 Synchronicity 50 g — — FDA listed —
5-In-1 Tinted Face Sunscreen - Golden Light 200 mg/g 69949-0053-01 Synchronicity 56.7 g — — FDA listed —
SPF 50 Sunscreen Stick 200 mg/g 79747-0004-01 ELEEO 14 g — — FDA listed —
Daily Moisturizing Glow Sunscreen Cream 200 mg/g 85326-0205-04 Shelley 113 g — — FDA listed —
Tinted Mineral Sunscreen 200 mg/g 85366-0204-60 Gentlehomme 60 g — — FDA listed —
non-tinted face and body mineral sunscreen SPF40 200 mg/g 85370-0205-04 Lisa 113 g — — FDA listed —
The Block 200 mg/g 85444-0204-60 ELITE 60 g — — FDA listed —
Tinted Mineral Sunscreen 200 mg/g 85469-0204-60 JMSE 60 g — — FDA listed —
Tinted Mineral Sunscreen Cream 200 mg/g 85554-0204-60 ESTILO 60 g — — FDA listed —
Sheer Mineral Face And Body Sunscreen Tinted 200 mg/g 85596-0204-60 LAURA 60 g — — FDA listed —
20 Zinc Oxide Tinted Mineral Sunscreen 200 mg/g 85621-0204-60 AGELESS 60 g — — FDA listed —
Tinted Ultra Zinc Face and Body 200 mg/g 85698-0204-60 LIV 60 g — — FDA listed —
Non Tinted Ultra Zinc Face and Body 200 mg/g 85698-0205-04 LIV 113 g — — FDA listed —
Daily Shade Sheer Matte 200 mg/g 85712-0205-04 BLISS 113 g — — FDA listed —
Not YO 80s Zinc Sunscreen 200 mg/g 85752-0205-15 CLEAN 15 g — — FDA listed —
Hint of Tint 200 mg/g 85768-0204-15 L.S. 1.5 g — — FDA listed —
Total Body Block Sunscreen 200 mg/g 85861-0205-15 ADR 1.5 g — — FDA listed —
Solar Shield Face and Body SPF 40 200 mg/g 85944-0205-04 BRIGHT 113 g — — FDA listed —
Tinted Mineral Sunscreen 200 mg/g 87122-0204-60 MADRE 60 g — — FDA listed —
Sun Defense Mineral Sunscreen SPF 30 Face 200 mg/g 54108-0420-01 derma 1 tube — — FDA listed —
CoTZ Flawless Complexion 200 mg/g 58892-0170-50 Fallien 1 tube — — FDA listed —
Proceuticals Private Label by TiZO tinted mineral sunscreen 20% zinc oxide 200 mg/g 58892-0204-50 Fallien 60 g — — FDA listed —
CVS Zinc Oxide 200 mg/g 69842-0065-34 CVS 1 tube — — FDA listed —
Natural Mineral Body Sunscreen 200 mg/g 69949-0100-01 Synchronicity 85 g — — FDA listed —
Healthy Mineral Sunscreen Brightening plus Tint 200 mg/g 85338-0204-60 ZEN 60 g — — FDA listed —
Sun Therapy Sunscreen 200 mg/g 85357-0204-60 Skin 60 g — — FDA listed —
Z Bloc 200 mg/g 85394-0205-04 The 113 g — — FDA listed —
Daily Skin Protection Sunscreen NT 200 mg/g 85479-0205-04 SKINPLUSBYOROYO 113 g — — FDA listed —
Deflectin Tinted Mineral Sunscreen 200 mg/g 85497-0204-60 AEON 60 g — — FDA listed —
Ultra Zinc Physical Defense 200 mg/g 85499-0205-04 ATLANTA 113 g — — FDA listed —
Color Smart Tinted Mineral 200 mg/g 85560-0204-60 MEGAN 60 g — — FDA listed —
Tinted Moisturizing Mineral Sunscreen 200 mg/g 85642-0204-60 EDIT 60 g — — FDA listed —
Mineral Sunscreen Face plus Body 200 mg/g 85727-0205-04 KS 113 g — — FDA listed —
Non-Tinted Mineral Sunscreen Broad Spectrum SPF 40 200 mg/g 85747-0205-04 WECARE 113 g — — FDA listed —
Daily Protect Tinted Mineral Sunscreen 200 mg/g 87199-0204-15 SARAH'S 1.5 g — — FDA listed —
Baby Mineral Sunscreen SPF55 200 mg/g 73418-0100-03 Hello 85.05 g — — FDA listed —
Zinc Oxide SPF 40 Non-Tinted 200 mg/g 85296-0205-04 Skin 113 g — — FDA listed —
Mineral Sunscreen For Face and Body 200 mg/g 85330-0205-04 Skin 113 g — — FDA listed —
Ultra Zinc Mineral Non Tinted 200 mg/g 85357-0205-04 Skin 113 g — — FDA listed —
Mineral Sunscreen Non-Tinted 200 mg/g 85372-0205-04 Glow 113 g — — FDA listed —
face Plus body sunscreen non-tinted 200 mg/g 85425-0205-04 Skin 113 g — — FDA listed —
Tinted Mineral Sunscreen 200 mg/g 85460-0204-60 Micro 60 g — — FDA listed —
Body-Screen 200 mg/g 85496-0205-04 MALORIE 113 g — — FDA listed —
Daytime Moisture SPF40 200 mg/g 85504-0204-60 COLETTE 60 g — — FDA listed —
Chem Free Sunscreen Tinted Formula 200 mg/g 85507-0204-60 IT 60 g — — FDA listed —
Non Tinted Mineral Sunscreen 20Percent Zinc Oxide 200 mg/g 85554-0205-04 ESTILO 113 g — — FDA listed —
Non - Tinted Mineral Sunscreen 200 mg/g 85575-0205-04 NEXTEX 113 g — — FDA listed —
Nourish And Defend 200 mg/g 85584-0204-60 ANASTASIA 60 g — — FDA listed —
20Percent Zinc Oxide Non Tinted 200 mg/g 85585-0205-15 JEFFREY 1.5 g — — FDA listed —
Royal Screen 200 mg/g 85616-0205-15 QUEENIES 15 g — — FDA listed —
Calming Protection SPF40 200 mg/g 85630-0205-04 FRESH 113 g — — FDA listed —
Tinted Sheer Mineral Zinc Sunscreen 200 mg/g 85887-0204-60 SKIN 60 g — — FDA listed —
Daily Protect Mineral Sunscreen 200 mg/g 87199-0205-04 SARAH'S 113 g — — FDA listed —
HEB SPF 50 Kids Purple Mineral Sunscreen Stick Grape Scented 200 mg/g 37808-0039-01 H.E.B. 13.3 g — — FDA listed —
TiZO Ultra Zinc SPF 40 (Tinted) 200 mg/g 58892-0319-01 Fallien 1 tube — — FDA listed —
TiZO ULTRA ZINC Non-Tinted SPF 40 MINERAL SUNSCREEN FOR BODY and FACE With Antioxidants C and E 200 mg/g 58892-0322-30 Fallien 30 g — — FDA listed —
CoTZ Baby 200 mg/g 58892-0618-01 Fallien 1 tube — — FDA listed —
Safeguard SPF 40 200 mg/g 83578-0205-35 Skinsalvation 100 g — — FDA listed —
Glow Shield Spf 200 mg/g 85291-0205-04 ACNE 113 g — — FDA listed —
Zinc Oxide SPF 40 Tinted 200 mg/g 85296-0204-60 Skin 60 g — — FDA listed —
Tinted Zinc Protection 200 mg/g 85339-0204-60 Teton 60 g — — FDA listed —
Prime And Protect Dewy 200 mg/g 85363-0204-60 Kalon 60 g — — FDA listed —
Non Tinted Mineral Sunscreen 200 mg/g 85395-0205-15 SPECKTRA6 1.5 g — — FDA listed —
Canopy Untinted 200 mg/g 85399-0205-04 BORREGO 113 g — — FDA listed —
Ultimate Physical Sunscreen Tinted 200 mg/g 85413-0204-60 HALEM 60 g — — FDA listed —
Solar Eclipse Extreme Sunscreen 200 mg/g 85491-0205-04 ULTRAVIOLET 113 g — — FDA listed —
Non-Tinted Zinc Body And Face SPF40 200 mg/g 85508-0205-15 RSL89 1.5 g — — FDA listed —
Moisturizing Face and Body SPF 200 mg/g 85552-0205-04 SKIN 113 g — — FDA listed —
Non Tinted Mineral Sunscreen 200 mg/g 85589-0205-04 Natur 113 g — — FDA listed —
Sheer Mineral Face And Body Sunscreen Non Tinted 200 mg/g 85596-0205-04 LAURA 113 g — — FDA listed —
Mermaid Glow And Go Non Tinted Mineral Sunscreen 200 mg/g 85647-0205-15 Mermaid 1.5 g — — FDA listed —
Simply Protected Tinted Mineral Sunscreen 200 mg/g 85726-0204-60 Healthy 60 g — — FDA listed —
Non-Tinted 20% Zinc Mineral Sunscreen 200 mg/g 85758-0205-04 BELLA 113 g — — FDA listed —
Eclipse Body Non Tinted 200 mg/g 85890-0205-04 DENISE 113 g — — FDA listed —
Kind Restore Tinted Mineral Sunscreen 200 mg/g 85895-0204-60 POLISH 60 g — — FDA listed —
Premier Zinc 200 mg/g 85971-0205-04 ENSO 113 g — — FDA listed —
TiZO Ultra Zinc SPF 40 (Non-Tinted) 200 mg/g 58892-0317-01 Fallien 1 tube — — FDA listed —
DermacinRx Zinc Oxide Skin Healing 200 mg/g 59088-0563-01 PureTek 4 g — — FDA listed —
Thinkbaby Sunscreen SPF 30 200 mg/g 60781-2003-01 thinkOperations,LLC 18.4 g — — FDA listed —
Tinted Mineral Sunscreen 20% Zinc Oxide 200 mg/g 85306-0204-21 INTEGRATIVE 60 g — — FDA listed —
Florida Babe Active Non-Tinted 20percent Zinc Oxide Mineral Sunscreen 200 mg/g 85337-0205-04 Tichy 113 g — — FDA listed —
Healthy Mineral Sunscreen Face and Body 200 mg/g 85338-0205-04 Zen 113 g — — FDA listed —
MATTE Non Tinted Mineral Sunscreen 200 mg/g 85386-0205-04 Allure 113 g — — FDA listed —
Mineral Sunscreen Zinc Oxide 200 mg/g 85414-0205-04 Hirschman, 113 g — — FDA listed —
Glass Skin Sunscreen Non-Tinted 200 mg/g 85428-0205-04 Fleur 113 g — — FDA listed —
Ultra Sheer Sunscreen 200 mg/g 85462-0205-04 SKINBAR 113 g — — FDA listed —
Gentle Mineral SPF 40 Tinted 200 mg/g 85555-0204-60 ELIZA 60 g — — FDA listed —
Tinted Mineral Sunscreen 200 mg/g 85589-0204-60 Natur 60 g — — FDA listed —
Instant Glow 200 mg/g 85599-0205-15 CLEAN 1.5 g — — FDA listed —
Non Tinted Moisturizing Mineral Sunscreen 200 mg/g 85642-0205-04 EDIT 113 g — — FDA listed —
Face and Body Sunscreen 200 mg/g 85696-0205-04 SCIENCE 113 g — — FDA listed —
Non Tinted Sheer Mineral Zinc Sunscreen 200 mg/g 85887-0205-04 SKIN 113 g — — FDA listed —
Eclipse Face Tinted 200 mg/g 85890-0204-60 DENISE 60 g — — FDA listed —
Mineral Sunscreen 20percent Zinc Oxide 200 mg/g 85987-0205-04 ESTHETICS 113 g — — FDA listed —
Bella Blue Skin Care Tinted Sunscreen 200 mg/g 87099-0204-60 BELLA 60 g — — FDA listed —
Dermatone SPF 50 Sunscreen Stick 200 mg/g 54414-0108-01 Dermatone 14 g — — FDA listed —
Daily Mineral Sunscreen 20% Zinc Oxide 200 mg/g 85306-0205-40 INTEGRATIVE 113 g — — FDA listed —
3-in-1 Daily Vanishing Tinted Sunscreen Cream 200 mg/g 85326-0204-60 Shelley 60 g — — FDA listed —
20Percent Zinc Oxide Sunscreen 200 mg/g 85364-0205-04 Minder 113 g — — FDA listed —
Zinc 20 mineral sunscreen face Plus body 200 mg/g 85367-0205-15 PURE 1.5 g — — FDA listed —
Tinted Mineral Sunscreen 200 mg/g 85375-0204-60 KLOE 60 g — — FDA listed —
Mineral Sunscreen 20percent Zinc Oxide 200 mg/g 85377-0205-04 Mantra 113 g — — FDA listed —
GLOW Tinted Mineral Sunscreen 200 mg/g 85386-0204-60 Allure 60 g — — FDA listed —
The Tinted Mineral Sunscreen 200 mg/g 85412-0204-60 The 60 g — — FDA listed —
Protect ME Non Tinted Mineral SPF 40 200 mg/g 85470-0205-04 PUREFECTION 113 g — — FDA listed —
Non Tinted Mineral Moisturizing Sunscreen 200 mg/g 85490-0205-04 ABOUT 113 g — — FDA listed —
Zinc 20Percent SPF 40 200 mg/g 85531-0205-04 JOHANNA'S 113 g — — FDA listed —
Cotz Sensitive SPF 40 Sunscreen 200 mg/g 58892-0418-01 Fallien 1 tube — — FDA listed —
Thinksport SPF 30 200 mg/g 60781-4487-01 thinkOperations,LLC 1 applicator — — FDA listed —
5-In-1 Tinted Face Sunscreen - Light 200 mg/g 69949-0052-01 Synchronicity 56.7 g — — FDA listed —
SPF 50 Sunscreen Stick 200 mg/g 84061-0129-01 Australian 14 g — — FDA listed —
Florida Babe Active Tinted 20percent Zinc Oxide Mineral Sunscreen 200 mg/g 85337-0204-60 Tichy 60 g — — FDA listed —
tinted face and body mineral sunscreen SPF40 200 mg/g 85370-0204-60 Lisa 60 g — — FDA listed —
Extreme Protection Non Tinted 200 mg/g 85403-0205-15 BIOHEALTH 1.5 g — — FDA listed —
Prevention Body 200 mg/g 85404-0205-15 NY 1.5 g — — FDA listed —
Ultimate Physical Sunscreen 200 mg/g 85413-0205-04 HALEM 113 g — — FDA listed —
Oil Free Anti-Aging 200 mg/g 85466-0204-60 DERMOPERFECTION 60 g — — FDA listed —
20 Zinc Oxide Non-Tinted Mineral Sunscreen 200 mg/g 85621-0205-04 AGELESS 113 g — — FDA listed —
Ultra UV Shade tinted moisturizing mineral SPF 40 200 mg/g 85632-0204-60 Joyce 60 g — — FDA listed —
Ultra Solar Shield non-tinted moisturizing mineral SPF 40 200 mg/g 85632-0205-04 Joyce 113 g — — FDA listed —
Sunshade Mineral Sunscreen 200 mg/g 85730-0205-04 BELLAGENA 113 g — — FDA listed —
Non-Tinted Mineral Sunscreen 200 mg/g 85805-0205-04 OLGA 113 g — — FDA listed —
Bella Blu Skin Care Non Tinted Sunscreen 200 mg/g 87099-0205-15 BELLA 1.5 g — — FDA listed —
Dew Mineral 200 mg/g 87197-0204-60 ADVANCED 60 g — — FDA listed —
HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry Scented 200 mg/g 37808-0000-01 H.E.B. 13.3 g — — FDA listed —
SPF 50 Sunscreen Stick 200 mg/g 63645-0178-05 OraLabs 14 g — — FDA listed —
Mineral Based Facial Sunscreen 200 mg/g 81679-0205-04 KATHLEEN 113 g — — FDA listed —
Clove Hill acne safe mineral sunscreen SPF 40 200 mg/g 82746-0205-04 Clove 115 g — — FDA listed —
Skin Apeel Pure Protect SPF 40 Broad Spectrum 200 mg/g 83628-0205-40 Skin 113 g — — FDA listed —
Signature Tint SPF 40 200 mg/g 85325-0204-60 ADVANCED 60 g — — FDA listed —
Tinted Mineral Sunscreen Zinc Oxide 200 mg/g 85414-0204-60 Hirschman, 60 g — — FDA listed —
face Plus body sunscreen tinted 200 mg/g 85425-0204-60 Skin 60 g — — FDA listed —
Advanced Mineral Sunscreen 200 mg/g 85452-0205-04 Charisma 113 g — — FDA listed —
Glow Shield 200 mg/g 85516-0204-60 Kristina 60 g — — FDA listed —
20Percent Zinc Total Protection 200 mg/g 85563-0205-04 CLEAR 113 g — — FDA listed —
Ultimate Mineral Protection 200 mg/g 85715-0205-04 MARK 113 g — — FDA listed —
Ageless All Fitz 200 mg/g 85736-0204-60 A.Wall 60 g — — FDA listed —
Yoali SPF 40 200 mg/g 85773-0204-60 YOALI 60 g — — FDA listed —
Aura Defense 200 mg/g 87271-0204-60 Grace 60 g — — FDA listed —
Endit zinc oxide skin protection 200 mg/g 64068-0500-01 EndIt 56.7 g — — FDA listed —
5-In-1 Tinted Face Sunscreen - Fair 200 mg/g 69949-0051-01 Synchronicity 56.7 g — — FDA listed —
5-In-1 Tinted Face Sunscreen - Medium 200 mg/g 69949-0054-01 Synchronicity 56.7 g — — FDA listed —
Tinted Mineral Sunscreen Broad Spectrum SPF 25 200 mg/g 72812-0152-01 Earth 84 g — — FDA listed —
Shunly Zn20 Tinted Light Moisturizer 200 mg/g 81381-0204-60 Shunly 60 g — — FDA listed —
True Tone Non Tinted 200 mg/g 85393-0205-04 That 113 g — — FDA listed —
Body Protect 200 mg/g 85463-0205-04 Noble 113 g — — FDA listed —
Luminous Tinted Moisturizing 200 mg/g 85503-0204-60 SKIN 60 g — — FDA listed —
Proceuticals Private Label by TiZO non-tinted mineral sunscreen 20% zinc oxide 200 mg/g 58892-0205-04 Fallien 113 g — — FDA listed —
Baby Mineral Sunscreen Probiotics SPF55 200 mg/g 73418-0101-03 Hello 85.05 g — — FDA listed —
Mineral Sunscreen SPF 50 200 mg/g 73418-0102-05 Hello 141.75 g — — FDA listed —
Medline 200 mg/g 53329-0255-05 Medline 170 g — — 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

🏛️
2011
On the market since
Sep 2011
📍
2026
Currently FDA-listed
15 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for THERA Calazinc Body Shield (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 272 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
68599-0205-01 You're viewing this 144 PACKET in 1 CARTON (68599-0205-1) / 4 g in 1 PACKET 2011-09-01 Active
68599-0205-04 113 g in 1 TUBE (68599-0205-4) 2011-09-01 Active

Pack size FAQ

What quantity is in NDC 68599-0205-01?
NDC 68599-0205-01 is listed by the FDA — 144 packet in 1 carton / 4 g in 1 packet.
What NDC number is used to bill for this package of THERA Calazinc Body Shield Zinc Oxide 200 mg/g Paste?
Bill NDC 68599-0205-01 — the 11-digit billing format is 68599020501. 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 68599-0205-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68599-0205-01, written without dashes as 68599020501. 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 68599-0205-01, the first segment (68599) is the labeler code FDA assigned to McKesson Medical-Surgical Inc.; the middle segment (0205) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by McKesson Medical-Surgical 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 1 other package presentation of this same product, including 113 g (68599-0205-04). 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?
McKesson Medical-Surgical 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 22 words ▾

Uses For the treatment and/or prevention of diaper rash temporarily protects and helps relieve minor skin irritation and itching due to rashes

⏱️ Dosage and Administration 38 words ▾

Directions Cleanse skin with THERA TM Moisturizing Body Cleanser or THERA TM Foaming Body Cleanser Apply paste to area as needed For G-tubes, cleanse as above, apply thin layer and secure with drain sponge or product as directed

⚠️ Warnings 51 words ▾

Warnings For external use only Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days

📦 Storage and Handling 8 words ▾

Other information Protect from freezing. Avoid excessive heat.

🧪 Active Ingredient 8 words ▾

Active ingredient Zinc Oxide 20.0% (3.0% as Calamine)

🧪 Inactive Ingredients 73 words ▾

Aleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, SAFFLEX TM (Consisting of: Calcium Pantothenate (Vitamin B 5 ), Maltodexdrin, Niacinamide (Vitamin B 3 ), Pyridoxine HCl (Vitamin B 6 ), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E)), Bisabolol, Carthamus Tinctorius (Safflower) Olesomes, Carthamus Tinctorius (Safflower) Seed Oil, Lavender Ylang Fragrance, Modified Corn Starch, Pentaerythrityl Tetra-di-t-Butyl Hydroxyhydrocinnamate, Petrolatum, Phenoxyethanol, Sodium Hyaluronate, Zingiber Officinale (Ginger) Root Extract.

🎯 Purpose 3 words ▾

Purpose Skin Protectant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68599-0204-01 · McKesson 68599-0206-04 · McKesson →
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.