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Soft Focus Mineral Defense Tinted Titanium Dioxide, Zinc Oxide 80 mg/g; 38 mg/g Cream, 53 g — NDC 85607-203-50 (Billing 85607-0203-50)

by SPOTLESS SKIN STUDIO · 53 g in 1 BOTTLE, PUMP

This is a package of 53 g of Soft Focus Mineral Defense Tinted Titanium Dioxide, Zinc Oxide 80 mg/g; 38 mg/g Cream from SPOTLESS SKIN STUDIO, marketed since Jul 2019 and currently FDA-listed. It is this product's only package size.

NDC 85607-0203-50
🏷️ FDA NDC (as labeled) 85607-203-50 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Titanium Dioxide, Zinc Oxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 3, 2024 — Microbial Contamination of Non-Sterile Product (Vivier Pharma, Inc.) · FDA recall D-0662-2024
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) 85607-203-50
Product NDC 85607-203
11-digit billing NDC 85607020350
UNII 15FIX9V2JP, SOI2LOH54Z
Application # M020
SPL Set ID 387f1ea9-4764-3abe-e063-6394a90adde0
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-07-16
Route TOPICAL
Dosage form CREAM
Substance TITANIUM DIOXIDE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 85607-203-50 — 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 → 85607-0203-50. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

🧪 What is this product?

Soft Focus Mineral Defense is a tinted cream applied to the skin that contains titanium dioxide and zinc oxide. These mineral ingredients are commonly used in over-the-counter sunscreen and sun protection products to reflect and scatter ultraviolet light away from the skin. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for sunscreen ingredients and category rather than undergoing individual product approval.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
85607-0203-50 You're viewing this Main listing 53 g in 1 BOTTLE, PUMP 2019-07-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Priia Tinted Mineral Sunscreen and Primer 80 mg/g; 38 mg/g 81493-0203-50 Priia 53 g — — FDA listed —
Shaded 80 mg/g; 38 mg/g 85319-0203-15 Potency 1.5 g — — FDA listed —
Prime And Protect Matte 80 mg/g; 38 mg/g 85363-0203-50 Kalon 53 g — — FDA listed —
non-tinted face mineral sunscreen SPF40 80 mg/g; 38 mg/g 85370-0202-50 Lisa 53 g — — FDA listed —
Non-Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85376-0202-15 HSC 15 g — — FDA listed —
Complexion Correction Tinted Primer Sunscreen 80 mg/g; 38 mg/g 85449-0201-85 MCRAE 85 g — — FDA listed —
Tinted Primer Anti-Aging 80 mg/g; 38 mg/g 85466-0203-50 DERMOPERFECTION 53 g — — FDA listed —
Tinted SPF40 80 mg/g; 38 mg/g 85531-0203-50 JOHANNA'S 53 g — — FDA listed —
Mattifying Mineral SPF 40 Tinted 80 mg/g; 38 mg/g 85555-0201-85 ELIZA 85 g — — FDA listed —
Tinted Mineral Primer SPF 40 80 mg/g; 38 mg/g 85591-0203-50 JOSEPHINA 53 g — — FDA listed —
Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85597-0203-50 ESTHETIC 53 g — — FDA listed —
Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85604-0203-15 ESTHETICS 15 g — — FDA listed —
Advanced Sun Protection 80 mg/g; 38 mg/g 85609-0201-85 HELLO 85 g — — FDA listed —
Prime Protection Sunscreen, tinted 80 mg/g; 38 mg/g 85641-0203-15 KRISTI 1.5 g — — FDA listed —
Mattify Total Protection Sunscreen 80 mg/g; 38 mg/g 85752-0203-50 CLEAN 53 g — — FDA listed —
PURE Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85774-0203-50 LA 53 g — — FDA listed —
Scalp Sunscreen 80 mg/g; 38 mg/g 85846-0203-50 FOLICULE 53 g — — FDA listed —
Mineral Sunscreen Tinted 80 mg/g; 38 mg/g 87003-0203-50 YUMA 53 g — — FDA listed —
Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 87049-0203-50 THE 53 g — — FDA listed —
Priia Tinted Mineral Sunscreen and Primer 80 mg/g; 38 mg/g 81493-0201-80 Priia 85 g — — FDA listed —
Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85302-0203-50 Face 50 g — — FDA listed —
Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85327-0203-50 Rhonda 53 g — — FDA listed —
Tinted Mineral Matte CE Sunscreen 80 mg/g; 38 mg/g 85394-0203-50 The 53 g — — FDA listed —
Mineral Fusion Tinted 80 mg/g; 38 mg/g 85416-0203-15 FOREFRONT 15 g — — FDA listed —
SUNerchi Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85422-0203-50 SYNERCHI 53 g — — FDA listed —
sheer tinted matte mineral 80 mg/g; 38 mg/g 85575-0203-50 NEXTEX 53 g — — FDA listed —
Daily Defense Facial Sunscreen Plus Primer 80 mg/g; 38 mg/g 85596-0203-50 LAURA 53 g — — FDA listed —
Happy Mineral Sunscreen Primer SPF 80 mg/g; 38 mg/g 85723-0203-50 ACNE 53 g — — FDA listed —
Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85728-0203-50 Dermacare 53 g — — FDA listed —
Sheer Mineral Sunscreen Silk Matte Finish 80 mg/g; 38 mg/g 85317-0202-50 TRU 53 g — — FDA listed —
Smoothing Mineral Sunscreen Non-Tinted 80 mg/g; 38 mg/g 85328-0202-50 DANIEL 53 g — — FDA listed —
Proper Protection Plus Primer Tinted 80 mg/g; 38 mg/g 85358-0203-50 Skin 53 g — — FDA listed —
Mineral Sunscreen 80 mg/g; 38 mg/g 85382-0203-50 DAISY'S 53 g — — FDA listed —
Sheer Mineral Sunscreen 80 mg/g; 38 mg/g 85394-0202-50 The 53 g — — FDA listed —
Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85513-0203-50 THE 53 g — — FDA listed —
Sun Elegant Mineral Sunscreen Tinted 80 mg/g; 38 mg/g 85519-0203-50 SKIN 53 g — — FDA listed —
Facial Mineral Sunscreen Mineral Protection 80 mg/g; 38 mg/g 85627-0203-50 CAPE 53 g — — FDA listed —
Tinted Facial Protection SPF40 80 mg/g; 38 mg/g 85630-0203-50 FRESH 53 g — — FDA listed —
Day Defense Tinted 80 mg/g; 38 mg/g 85695-0203-50 THE 53 g — — FDA listed —
Mineral Matte Non-Tinted Sunscreen 80 mg/g; 38 mg/g 85939-0202-50 ORAIOS 53 g — — FDA listed —
PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreen 80 mg/g; 38 mg/g 58892-0203-50 Fallien 53 g — — FDA listed —
HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen Tinted 80 mg/g; 38 mg/g 81679-0203-50 Hutton, 53 g — — FDA listed —
Matte Mineral Sunscreen 80 mg/g; 38 mg/g 85330-0203-50 Skin 53 g — — FDA listed —
Mineral Primer tinted SPF40 80 mg/g; 38 mg/g 85356-0203-50 Oracle 53 g — — FDA listed —
Proper Protection Plus Primer NT 80 mg/g; 38 mg/g 85358-0202-15 Skin 1.5 g — — FDA listed —
Tinted Mineral 40 80 mg/g; 38 mg/g 85392-0203-15 2301 1.5 g — — FDA listed —
Replenishing Tinted Sunscreen 80 mg/g; 38 mg/g 85418-0203-50 Beauty 53 g — — FDA listed —
Complexion Correction Primer Sunscreen clear 80 mg/g; 38 mg/g 85449-0202-15 MCRAE 1.5 g — — FDA listed —
Complexion Correction Tinted Primer Sunscreen 80 mg/g; 38 mg/g 85449-0203-15 MCRAE 1.5 g — — FDA listed —
Anti-Aging Sun Protection NT 80 mg/g; 38 mg/g 85466-0202-50 DERMOPERFECTION 53 g — — FDA listed —
Skin Filter Matte SPF 80 mg/g; 38 mg/g 85496-0203-50 MALORIE 53 g — — FDA listed —
Tinted Facial Mineral Sunscreen SPF 40 80 mg/g; 38 mg/g 85508-0203-15 RSL89 1.5 g — — FDA listed —
Rejuvn8 80 mg/g; 38 mg/g 85635-0203-50 FLEUR 53 g — — FDA listed —
Matte Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85642-0203-50 EDIT 53 g — — FDA listed —
Tinted Facial Sunscreen 80 mg/g; 38 mg/g 85679-0203-50 HELTON 53 g — — FDA listed —
Age Defying Mineral Protection 80 mg/g; 38 mg/g 85715-0202-50 MARK 53 g — — FDA listed —
Non-Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 87049-0202-50 THE 53 g — — FDA listed —
Perfect Mineral Sunscreen 80 mg/g; 38 mg/g 87162-0203-15 SKIN 1.5 g — — FDA listed —
Anti-Aging Tinted Sunscreen 80 mg/g; 38 mg/g 87444-0201-85 LASER 85 g — — FDA listed —
Shunly Radiant Translucent SPF 40 80 mg/g; 38 mg/g 81381-0202-50 Shunly 53 g — — FDA listed —
Healthy Mineral Sunscreen No Shine - No Tint 80 mg/g; 38 mg/g 85338-0202-50 Zen 53 g — — FDA listed —
Dr B Clinical Skin Care Non Tinted Sunscreen 80 mg/g; 38 mg/g 85365-0202-50 NAIRA 53 g — — FDA listed —
Tinted Minerals 1point8 oz 80 mg/g; 38 mg/g 85395-0203-50 SPECKTRA6 53 g — — FDA listed —
UV Defense Mineral Sunscreen 80 mg/g; 38 mg/g 85495-0202-50 CCLEAR 53 g — — FDA listed —
Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85585-0203-50 JEFFREY 53 g — — FDA listed —
Soft Focus Mineral Defense Tinted 80 mg/g; 38 mg/gthis 85607-0203-50 SPOTLESS 53 g — — FDA listed —
Mineral Mousse 80 mg/g; 38 mg/g 85629-0203-50 CLARITY 53 g — — FDA listed —
Facial Mineral Sunscreen Tinted 80 mg/g; 38 mg/g 85634-0203-50 DR. 53 g — — FDA listed —
UV Protection Veil Mineral Sunscreen non tinted 80 mg/g; 38 mg/g 85926-0202-50 ATHENA 53 g — — FDA listed —
sheer tinted sunscreen 80 mg/g; 38 mg/g 85968-0203-50 SARA 53 g — — FDA listed —
CoTZ Face Prime and Protect SPF 40 (Tinted) 80 mg/g; 38 mg/g 58892-0354-45 Fallien 1 tube — — FDA listed —
Shunly Radiant Translucent Tinted SPF 40 80 mg/g; 38 mg/g 81381-0203-50 Shunly 53 g — — FDA listed —
BHSkin Sheer Tinted Zinc and Titanium SPF 40 80 mg/g; 38 mg/g 83095-0203-50 Don 53 g — — FDA listed —
Silk Screen 80 mg/g; 38 mg/g 83628-0201-85 Skin 85 g — — FDA listed —
Protect Mineral Sunscreen Non-Tinted 80 mg/g; 38 mg/g 85314-0202-50 Melinda 53 g — — FDA listed —
Mineral Primer non-tinted SPF40 80 mg/g; 38 mg/g 85356-0202-50 Oracle 53 g — — FDA listed —
Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85376-0203-50 HSC 53 g — — FDA listed —
Tinted Mineral Moisturizing Sunscreen 80 mg/g; 38 mg/g 85490-0203-50 ABOUT 53 g — — FDA listed —
Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85492-0203-50 The 53 g — — FDA listed —
Facial Mineral Fusion 80 mg/g; 38 mg/g 85507-0203-50 IT 53 g — — FDA listed —
Prime and Protect 80 mg/g; 38 mg/g 85557-0203-50 Shannon 53 g — — FDA listed —
non-tinted sheer matte mineral 80 mg/g; 38 mg/g 85575-0202-50 NEXTEX 53 g — — FDA listed —
Matte Finish 80 mg/g; 38 mg/g 85599-0203-15 CLEAN 1.5 g — — FDA listed —
Tinted Primer Mineral Sunscreen 80 mg/g; 38 mg/g 85640-0203-50 CECILIA 53 g — — FDA listed —
Barrier Plus Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85726-0203-50 Healthy 53 g — — FDA listed —
Mineral Sunscreen Non Tinted 80 mg/g; 38 mg/g 85798-0202-50 SAN 53 g — — FDA listed —
Mineral Sunscreen Tinted 80 mg/g; 38 mg/g 85987-0203-50 ESTHETICS 53 g — — FDA listed —
Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen Backbar 80 mg/g; 38 mg/g 58892-0201-85 Fallien 85 g — — FDA listed —
Flawless Brightening Sunscreen 80 mg/g; 38 mg/g 81535-0201-85 Flawless 85 g — — FDA listed —
Mineral SPF 40, Tinted 80 mg/g; 38 mg/g 85292-0203-15 Acne 1.5 g — — FDA listed —
Tinted Physical Block Sunscreen 80 mg/g; 38 mg/g 85301-0203-15 Tucson 1.5 g — — FDA listed —
Mineral Sunscreen tinted 80 mg/g; 38 mg/g 85302-0201-85 Face 85 g — — FDA listed —
Matte Velvet Tint 80 mg/g; 38 mg/g 85334-0203-50 Brent 53 g — — FDA listed —
Non Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85374-0202-50 BABYFACE 53 g — — FDA listed —
Non Tinted Sunscreen 80 mg/g; 38 mg/g 85381-0202-50 VIDA 53 g — — FDA listed —
AcneFix Non-Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85396-0202-50 ACNEFIX 53 g — — FDA listed —
Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85414-0201-85 Hirschman, 85 g — — FDA listed —
Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85442-0203-50 Saving 53 g — — FDA listed —
Advanced Sun Protection 80 mg/g; 38 mg/g 85609-0203-50 HELLO 53 g — — FDA listed —
Advanced Formula Tinted 80 mg/g; 38 mg/g 85883-0203-50 CR 53 g — — FDA listed —
CoTZ Face Prime and Protect SPF 40 (Non-Tinted) 80 mg/g; 38 mg/g 58892-0348-45 Fallien 1 tube — — FDA listed —
Tinted Mineral Sunscreen Spf 40 80 mg/g; 38 mg/g 85344-0203-50 DERMATOLOGY 53 g — — FDA listed —
Non-Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85359-0202-50 R. 53 g — — FDA listed —
Tinted Mineral Sun Protectant 80 mg/g; 38 mg/g 85459-0203-15 PANDA 1.5 g — — FDA listed —
Tinted Physical Defense 80 mg/g; 38 mg/g 85499-0203-50 ATLANTA 53 g — — FDA listed —
Silk Screen Tinted 80 mg/g; 38 mg/g 85644-0203-50 Skin 53 g — — FDA listed —
Day Defense 80 mg/g; 38 mg/g 85695-0202-50 THE 53 g — — FDA listed —
Non-Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85302-0202-50 Face 50 g — — FDA listed —
Shaded 80 mg/g; 38 mg/g 85319-0201-85 Potency 85 g — — FDA listed —
Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85329-0203-50 Lily 53 g — — FDA listed —
Tinted Sunscreen 80 mg/g; 38 mg/g 85331-0203-15 Scottsdale 15 g — — FDA listed —
Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85359-0203-50 R. 53 g — — FDA listed —
Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85372-0203-50 Glow 53 g — — FDA listed —
Prevention 80 mg/g; 38 mg/g 85463-0203-50 Noble 53 g — — FDA listed —
ProtectME Tinted Mineral SPF 40 80 mg/g; 38 mg/g 85470-0203-50 PUREFECTION 53 g — — FDA listed —
Mattifying Skin Primer 80 mg/g; 38 mg/g 85552-0202-50 SKIN 53 g — — FDA listed —
Mattifying Mineral SPF40 Tinted 80 mg/g; 38 mg/g 85555-0203-50 ELIZA 53 g — — FDA listed —
Mineral Sunscreen Non-Tinted 80 mg/g; 38 mg/g 85558-0202-50 LOTUS 53 g — — FDA listed —
UV Shade tinted matte mineral SPF 40 80 mg/g; 38 mg/g 85632-0201-85 Joyce 85 g — — FDA listed —
Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85696-0203-50 SCIENCE 53 g — — FDA listed —
Tinted Sunscreen Face Primer 80 mg/g; 38 mg/g 85698-0203-50 LIV 53 g — — FDA listed —
Sheer Tinted Sunscreen SPF40 80 mg/g; 38 mg/g 85706-0203-50 SIMPLICITY 53 g — — FDA listed —
Daily Shade Matte Tinted 80 mg/g; 38 mg/g 85712-0203-50 BLISS 53 g — — FDA listed —
Tinted Primer Mineral Sunscreen 80 mg/g; 38 mg/g 85715-0203-50 CECILIA 53 g — — FDA listed —
UV Protection Veil Mineral Sunscreen, tinted 80 mg/g; 38 mg/g 85926-0203-15 ATHENA 15 g — — FDA listed —
Emme Diane Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 81377-0203-50 Emme 53 g — — FDA listed —
Clove Hill Tinted Mineral Sunscreen SPF 40 80 mg/g; 38 mg/g 82746-0203-50 Clove 53 g — — FDA listed —
Non-Tinted Matte Mineral Sunscreen 80 mg/g; 38 mg/g 85330-0202-50 Skin 53 g — — FDA listed —
Florida Babe Sport Tinted Mineral Sunscreen 80 mg/g; 38 mg/g 85337-0203-15 Tichy 1.5 g — — FDA listed —
Mineral Sunscreen Dry Touch NT 80 mg/g; 38 mg/g 85431-0202-50 Cutis 53 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

🏛️
2019
On the market since
Jul 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

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

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

Inactive Ingredients / Excipients

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

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

  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII XHK3U310BA
    Cyclohexasiloxane is a silicon-based liquid that acts as a solvent and conditioning agent in medicines. It helps dissolve or carry other ingredients and improves how the product spreads or feels on the skin.
  • UNII 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • 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 UF7620L1W6
    A synthetic silicone polymer that acts as a thickener and absorbent in medicines. It helps create the right texture, improves how the product feels on skin or in the mouth, and can absorb excess moisture or oil in formulations.
  • UNII 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • UNII T74O12AN6Y
    A silicone oil that reduces foam and prevents clumping. It's used as an anti-foaming agent and lubricant in tablets and capsules to improve how the medicine flows during manufacturing.
  • UNII 12Z59IF64N
    Hydrogen dimethicone is a silicone-based fluid that acts as a lubricant and anti-foaming agent in medicines. It helps the product flow smoothly during manufacturing and prevents excess air bubbles from forming.
  • UNII ZJ5S27D9NX
    A silicone-based substance that combines polymers with lauryl (a fatty compound). It acts as an emulsifier and surfactant to help mix oil and water ingredients and improve how the medicine feels when applied or swallowed.
  • UNII 8PR7V1SVM0
    A silicone-based lubricant combined with polyethylene glycol. It reduces friction and helps the medicine flow smoothly during manufacturing and improves how the product feels when applied or swallowed.
  • UNII 9LBV3F07AZ
    A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during storage.

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

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

LabelerSPOTLESS SKIN STUDIO
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code85607
First marketedJul 2019
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.

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.
📄 FDA label
📄 FDA label 9 words ▾

No readable label sections were found for this product.

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 Titanium Dioxide, Zinc Oxide — the ingredient across all brands.

Top reported reactions

Exposure To Toxic Agent7
Product Contamination Chemical5
Acute Myeloid Leukaemia4
Malignant Melanoma4
Neoplasm Malignant4
Sunburn4
Application Site Rash3

Age at onset

Child1
Adolescent1
Adult7
Elderly2

Reporter sex

44 reports
Male · 24%
Female · 76%

Serious outcomes

Hospitalization7
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 11 1
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by SPOTLESS SKIN STUDIO. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SPOTLESS SKIN STUDIO is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.