Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Sunforgettable Total Protection Sheet Matte Sunscreen SPF 30 Zinc Oxide 225 mg/g Powder, 1 tube — NDC 68078-036-01 (Billing 68078-0036-01)
by Colorescience · 1 TUBE, WITH APPLICATOR in 1 CARTON / 4.3 g in 1 TUBE, WITH APPLICATOR
This is a package of 1 tube of Sunforgettable Total Protection Sheet Matte Sunscreen SPF 30 Zinc Oxide 225 mg/g Powder from Colorescience, marketed since Jul 2020 and currently FDA-listed. It is this product's only package size.
NDC 68078-0036-01
🏷️ FDA NDC (as labeled)
68078-036-01
billing pads the product segment with a zero
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 68078-036-01 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 68078 labeler · 036 product · 01 package
- Package marketed since
- Jul 20, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 6807803601 8
- FDA record last changed
- Jul 24, 2026
⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
68078-036-01
Product NDC
68078-036
11-digit billing NDC
68078003601
UNII
SOI2LOH54Z
Application #
M020
SPL Set ID
5b6f906e-6620-48b0-9c39-0eb1c8dc1c63
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2020-07-20
Route
TOPICAL
Dosage form
POWDER
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 68078-036-01 — 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 → 68078-0036-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
🧪 What is this product?
Sunforgettable Total Protection Sheet Matte Sunscreen SPF 30 is a powder applied to the skin that contains zinc oxide as its active ingredient. Zinc oxide is a mineral sunscreen agent that works by sitting on the skin surface to reflect and scatter ultraviolet (UV) radiation. This product is marketed as an over-the-counter sunscreen under FDA's monograph rules for sunscreen drugs and is intended to help protect skin from sun exposure when applied as directed.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
💬 Questions about Zinc Oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per g | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 6, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 68078-0036-01 You're viewing this Main listing | 1 TUBE, WITH APPLICATOR in 1 CARTON / 4.3 g in 1 TUBE, WITH APPLICATOR | 2020-07-20 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sunforgettable Total Protection Sheet Matte Sunscreen SPF 30 225 mg/gthis 68078-0036-01 | Colorescience | 1 tube | — | — | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2020
On the market since
Jul 2020
📍
2026
Currently FDA-listed
6 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.
- FDA Orange Book · refreshed Oct 3, 2026
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 H895X08VNQ
A silicone-based polymer that forms small, hard particles. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
-
UNII 9KB5R958PB
A silicone-based polymer that forms a protective barrier on skin or mucous membranes. Used in topical formulations as an emollient, water-repellent coating, and skin protectant to reduce moisture loss and irritation.
-
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 PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII W2ZU1RY8B0
A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
-
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 VYT2JA85NH
A plant extract from cogon grass roots used in some formulations. It may serve as a natural filler, thickening agent, or ingredient to help bind tablet components together.
-
UNII 1K92T9919H
A synthetic surfactant derived from cetyl alcohol and ethylene oxide. It helps dissolve and mix oils with water in formulations, acting as an emulsifier and solubilizer to create uniform medicines.
-
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 6777U11MKT
A silicone-based lubricant and anti-foaming agent used to reduce surface tension and prevent foam formation during manufacturing and storage of the medication.
-
UNII V8A1AW0880
Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
-
UNII 1VPU26JZZ4
Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
-
UNII 2JFK226947
A plant extract from oak tree bark used as a natural binding and thickening agent in medicines. It helps hold ingredients together and may add astringent properties to the formulation.
-
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 OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
-
UNII 3W1JG795YI
Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
-
UNII WL3883U2PO
A natural resin derived from the caesalpinia spinosa plant, used as a binder and film-forming agent to help hold tablet ingredients together and create a protective coating on the medicine's surface.
-
UNII LDC331P08E
A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
-
UNII C34U15ICXA
A plant extract from grape seeds that acts as an antioxidant and preservative in medications. It helps protect the active ingredients from degrading and extends the product's shelf life.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
22 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesMica, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol/Propylsilsequioxane/Silicate Crosspolymer, Methicone, Maltodextrin, Silica, Glycerin, Club Moss (Lycopodium Clavatum) Extract, Sodium Hyaluronate, Grape (Vitis Vinifera) Seed Extract, Green Tea (Camellia Sinensis) Leaf Extract, Oak (Quercus Robur) Wood Extract, Cogon Grass (Imperata Cylindrica) Root Extract, Water, Tara (Caesalpinia Spinosa) Fruit Pod Extract, Sunflower (Helianthus Annuus) Sprout Extract, Isoceteth-10, Triethoxycaprylylsilane, Sodium Benzoate, Potassium Sorbate, Iron Oxides (CI77491, CI 77492, CI 77499).
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerColorescience
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code68078
First marketedJul 2020
Product typeHuman Otc Drug
Portfolio35 products on file
More NDCs from Colorescience labeler code 68078
- Total Eye 3-In-1 Renewal Therapy SPF 35 Titanium Dioxide and Zinc Oxide 79 mg/mL; 67 mg/mL Liquid NDC 68078-024-01
- Sunforgettable Total Protection Brush-On Shield SPF 50 Titanium Dioxide and Zinc Oxide 225 mg/g; 225 mg/g Powder NDC 68078-027-01
- Lip Shine SPF35 Sunscreen Zinc Oxide 66 mg/mL Liquid NDC 68078-028-01
- Sunforgettable Total Protection Color Balm (Berry) Zinc Oxide 125 mg/g Stick NDC 68078-033-02
- Sunforgettable Total Protection Color Balm (Blush) Zinc Oxide 125 mg/g Stick NDC 68078-034-02
- Sunforgettable Total Protection Color Balm (Bronze) Zinc Oxide 125 mg/g Stick NDC 68078-035-02
- Brightening Primer SPF 20 titanium dioxide and zinc oxide 50 mg/mL; 4.5 mg/mL Liquid NDC 68078-037-01
- Sunforgettable Total Protection Face Shield Matte Zinc Oxide 135.6 mg/mL Lotion NDC 68078-038-02
- Mattifying Primer SPF 20 Titanium Dioxide and Zinc Oxide 50 mg/mL; 4.5 mg/mL Liquid NDC 68078-039-01
- Calming Primer SPF 20 Titanium Dioxide and Zinc Oxide 54 mg/mL; 54 mg/mL Liquid NDC 68078-040-01
- Sunforgettable Total Protection Face Shield Glow Zinc Oxide 135.6 mg/mL Lotion NDC 68078-041-02
- Sunforgettable Total Protection Face Shield Flex Zinc Oxide 135.6 mg/mL Lotion NDC 68078-042-02
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Do Not Use
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
⏱️ Dosage and Administration ▾
Directions Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.
Children under 6 months of age: Ask a doctor. Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m.– 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses.
⚠️ Warnings ▾
Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information Protect this product from excessive heat and direct sun.
🧪 Active Ingredient ▾
Active ingredients Zinc Oxide 22.5%
🧪 Inactive Ingredients ▾
Inactive ingredients Mica, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol/Propylsilsequioxane/Silicate Crosspolymer, Methicone, Maltodextrin, Silica, Glycerin, Club Moss (Lycopodium Clavatum) Extract, Sodium Hyaluronate, Grape (Vitis Vinifera) Seed Extract, Green Tea (Camellia Sinensis) Leaf Extract, Oak (Quercus Robur) Wood Extract, Cogon Grass (Imperata Cylindrica) Root Extract, Water, Tara (Caesalpinia Spinosa) Fruit Pod Extract, Sunflower (Helianthus Annuus) Sprout Extract, Isoceteth-10, Triethoxycaprylylsilane, Sodium Benzoate, Potassium Sorbate, Iron Oxides (CI77491, CI 77492, CI 77499).
🎯 Purpose ▾
Purpose Sunscreen
📄 Do Not Use ▾
Do not use on damaged or broken skin.
📄 When Using This Product ▾
When using this product keep out of eyes. Rinse with water to remove.
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if rash occurs.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions or comments? Call toll free 866.426.5673
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 4.3 g Tube Carton colorescience ® SUNFORGETTABLE ® TOTAL PROTECTION™ SHEER MATTE SUNSCREEN + Protects from UVA/UVB, pollution, blue light, IR + Absorbs excess oil, mattifies + Mess-free application 30 Broad Spectrum SPF 30 Sunscreen PA+++ CHEMICAL-FREE ACTIVES | 100% MINERAL Net Wt. 4.3 g / 0.15 oz. Principal Display Panel - 4.3 g Tube Carton
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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 Colorescience. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Colorescience 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.
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.