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Critic Aid Skin Zinc oxide 200 mg/g Paste, 71 g — NDC 11701-0050-33 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Critic Aid Skin Zinc oxide 200 mg/g Paste, 71 g — NDC 11701-050-33 (Billing 11701-0050-33)

by Coloplast Corp · 71 g in 1 TUBE

This is a package of 71 g of Critic Aid Skin Zinc oxide 200 mg/g Paste from Coloplast Corp, marketed since Jun 2009 and currently FDA-listed.

NDC 11701-0050-33
🏷️ FDA NDC (as labeled) 11701-050-33 billing pads the product segment with a zero
This package
Contains71 g Pack sizes2 compare ↓
Product page 11701-0050-32 Also comes in: 170 g 11701-050-32
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
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) 11701-050-33
Product NDC 11701-050
11-digit billing NDC 11701005033
NCPDP billing unit GM — per gram (weight)
RxCUI 416684, 1486031
UNII SOI2LOH54Z
Application # M015
SPL Set ID caaac1f0-437d-4185-8670-9f11b9cefe63
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-06-15
Route TOPICAL
Dosage form PASTE
Substance ZINC OXIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90972000004400
GPI class Critic-Aid Thick Moist Barrier
GCN Seq No 061779
GCN 97564
HICL code 034222
Ingredient (HICL) Zinc Oxide/Petrolatum, Yellow
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 CRITIC-AID SKIN PASTE
FDB brand name Critic-Aid
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 061779
  • GCN: 97564
  • GPI-14 (Medi-Span): 90972000004400
  • HICL (First Databank): 034222
  • AHFS class code: 84:24.12.00
  • RxCUI (RxNorm): 416684
Why two NDCs? The FDA registers this code as 11701-050-33 — 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 → 11701-0050-33. 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

Label name CRITIC-AID SKIN PASTE Ingredient Zinc Oxide/Petrolatum, Yellow
🧪 What is this product?

Critic Aid Skin Zinc Oxide is a topical paste containing zinc oxide, an over-the-counter monograph drug sold under FDA's established rules for this category. Zinc oxide is commonly used in skin-care products to help protect and soothe irritated or damaged skin. This paste form is applied directly to the affected area of the skin.

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: 170 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
11701-0050-32 11701-050-32 Main listing 170 g in 1 TUBE 2009-06-15 — Active
11701-0050-33 You're viewing this 71 g in 1 TUBE 2009-06-15 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 71 g — 71 g in 1 tube.
How does this package differ from NDC 11701-0050-32?
Both are Critic Aid Skin Zinc oxide 200 mg/g Paste — the drug itself is identical. This page's package is the 71 g one, while NDC 11701-0050-32 is the 170 g package.
What NDC number is used to bill for this package of Critic Aid Skin Zinc oxide 200 mg/g Paste?
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
Leader Zinc Oxide 200 mg/g 70000-0334-01 Cardinal 454 g $0.015 — Availability likely —
Nivagen Zinc Oxide 200 mg/g 75834-0170-01 Nivagen 28.4 g $0.105 — Availability likely —
Critic Aid Skin 200 mg/gthis 11701-0050-33 Coloplast 71 g — — FDA listed —
Medline 200 mg/g 53329-0255-05 Medline 170 g — — FDA listed —
DermacinRx Zinc Oxide Skin Healing 200 mg/g 59088-0563-01 PureTek 4 g — — FDA listed —
Zinctral 20 g/100g 59088-0627-05 PureTek 57 g — — FDA listed —
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 —
CoTZ Kids 200 mg/g 58892-0619-05 Fallien 5 g — — FDA listed —
THERA Calazinc Body Shield 200 mg/g 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 —
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 —
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

🏛️
2009
On the market since
Jun 2009
📍
2026
Currently FDA-listed
17 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • 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 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.

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

The official label also statesCellulose Gum (CMC), Dimethicone, Petrolatum

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

LabelerColoplast Corp
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code11701
First marketedJun 2009
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.

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 21 words ▾

Uses Helps protect minor skin irritation due to diaper rash Protects chafed skin due to diaper rash Helps seal out wetness

⏱️ Dosage and Administration 35 words ▾

Directions Clean the affected area and dry thoroughly Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a doctor. Change wet and soiled absorbent brief/diapers promptly.

⚠️ Warnings 57 words ▾

Warnings For external use only. When using this product: avoid contact with eyes Consult a doctor: if condition worsens or does not improve within 7 days. Do not use on: deep or puncture wounds animal bites serious burns Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active ingredients Zinc Oxide: 20%

🧪 Inactive Ingredients 7 words ▾

Inactive ingredients Cellulose Gum (CMC), Dimethicone, Petrolatum

🎯 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 ↗

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 Critic Aid Skin (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

0 reports

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.

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 Coloplast Corp. 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 170 g (11701-0050-32). 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?
Coloplast Corp 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.
← 11701-0048-14 · Coloplast 11701-0052-04 · Coloplast →
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.