Over-the-counter drug · OTC MONOGRAPH DRUG
Cream (Zinc oxide) NDC 78518-006
Zinc oxide 18.8 mg/100mg · Cream · Topical · MONAT GLOBAL CORP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78518-006-01 | 78518000601 | 1 TUBE in 1 CARTON (78518-006-01) / 35 mg in 1 TUBEMarketed from Sep 12, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cream
- Generic name (nonproprietary)
- zinc oxide
- Active ingredients
- Zinc oxide — 18.8 mg/100mg
- Dosage form
- Cream
- Route
- Topical
- Labeler
- MONAT GLOBAL CORPNDC labeler code 78518
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 020
- Marketing start
- Listing expires
- Identifiers
- Product ID 78518-006_46e05579-7673-e42b-e063-6294a90acd3cSPL ID 46e05579-7673-e42b-e063-6294a90acd3cSPL set ID e922d89c-4232-77d8-e053-2995a90a85e5UNII SOI2LOH54Z
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N478518000601followed by a unit qualifier and the quantityPackage 78518-0006-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
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.
Excerpt only. Read the full label for complete information.
About NDC 78518-006
- What is NDC 78518-006?
- 78518-006 is the product NDC for Cream (zinc oxide), Zinc oxide 18.8 mg/100mg cream, listed with the FDA by MONAT GLOBAL CORP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cream (Zinc oxide).
- What is the active ingredient?
- Zinc oxide.
- Who is the labeler?
- MONAT GLOBAL CORP, NDC labeler code 78518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cream?
- 3 other product NDCs are listed under this name. See all Cream NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cream products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Creamzinc oxide | Zinc oxide 21.76 mg/100mg | CreamTopical | Oxygen Development LLC | 61354-115 | 61354-0115-02 |
| Creamzinc oxide | Zinc oxide 18.8 mg/100mg | CreamTopical | MONAT GLOBAL CORP | 78518-003 | 78518-0003-01 |
| Creamzinc oxide | Zinc oxide 18.8 mg/100mg | CreamTopical | MONAT GLOBAL CORP | 78518-007 | 78518-0007-01 |
Other NDCs under M 020
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| (Re) Setting 100% mineral Powder Deep Broad Spectrum SPF 35zinc oxide | Zinc oxide 24.7 g/100g | PowderTopical | Supergoop, LLC | 75936-168 |
| (Re) Setting 100% mineral Powder Light Broad Spectrum SPF 35zinc oxide | Zinc oxide 24.7 g/100g | PowderTopical | Supergoop, LLC | 75936-166 |
| (RE) Setting 100% Mineral Powder Medium Broad Spectrum Sunscreen SPF 35zinc oxide | Zinc oxide 24.7 g/100g | PowderTopical | Supergoop, LLC | 75936-167 |
| (RE) Setting 100% Mineral Powder Translucent Broad Spectrum Sunscreen SPF 35zinc oxide | Zinc oxide 24.7 g/100g | PowderTopical | Supergoop, LLC | 75936-169 |
| (Re)Setting Refreshing Mist SPF 40avobenzone, homosalate, octisalate, octocrylene | Avobenzone 2.9 g/100mL + 3 more ingredients | SprayTopical | Supergoop, LLC | 75936-361 |
| (S)Undercover SPF 50zinc oxide | Zinc oxide 12 g/100mL | LotionTopical | TUBBY TODD | 73088-106 |
| 10 Armani Prima Control Glow Moisturizer SBS SPF 35octinoxate, titanium dioxide | Octinoxate 50 mg/mL; Titanium dioxide 19 mg/mL | CreamTopical | BPS 60 | 70581-019 |
| 100% Mineral Broad Spectrum Sunscreen SPF 30titanium dioxide, zinc oxide | Zinc oxide 16 g/100mL | LotionTopical | Supergoop LLC | 75936-363 |
| 100% Mineral Broad Spectrum Sunscreen SPF 50titanium dioxide, zinc oxide | Titanium dioxide 2.3 g/100mL; Zinc oxide 17.9 g/100mL | LotionTopical | Supergoop LLC | 75936-362 |
| 100% Mineral Sunscreen | Zinc oxide 15 g/100mL; Titanium dioxide 10 g/100mL | CreamCutaneous | Guangzhou Pallas Cosmetics Co.,Ltd. | 84484-001 |
| 1000 Roses CC Color plus Correct Sheer Beige SPF 30zinc oxide | Zinc oxide 200 mg/mL | LotionTopical | Andalou naturals | 55560-0110 |
| 1000 Roses CC Color Plus Correct Sheer Tan SPF 30zinc oxide | Zinc oxide 200 mg/mL | LotionTopical | Andalou naturals | 55560-0106 |
| 1000 Roses Daily Shade Facial SPF 18octisalate, octocrylene, and avobenzone | Octisalate 50 mg/mL + 2 more ingredients | LotionTopical | Andalou naturals | 55560-0103 |
| 111 Skin Sunscreen SPF 50zinc oxide | Zinc oxide 19.5 g/100mL | SolutionTopical | Bentley Laboratories, LLC | 54111-190 |
| 1177, 1178 Sunscreen | Octinoxate 7.5 g/100g + 3 more ingredients | CreamTopical | Dynarex | 67777-177 |
| 12 Days of Derm-Loved Skincareoctinoxate, zinc oxide, oatmeal, benzoyl peroxide, avobenzone, octisalate, octocrylene | — | KitTopical | Rodan & Fields | 14222-7000 |
| 20 Zinc Oxide Non-Tinted Mineral Sunscreenzinc oxide | Zinc oxide 200 mg/g | CreamTopical | AGELESS SKINCARE INC | 85621-205 |
| 20 Zinc Oxide Tinted Mineral Sunscreenzinc oxide | Zinc oxide 200 mg/g | CreamTopical | AGELESS SKINCARE INC | 85621-204 |
| 2000Dl-Cl30Tspf30 bs tropical | Octocrylene 2.34 g/30mL; Avobenzone .9 g/30mL | LotionTopical | Epic Laboratories, LLC | 58418-004 |
| 2000Dl-Cl30Vspf30 bs original | Octocrylene 2.34 g/30mL; Avobenzone .9 g/30mL | LotionTopical | Epic Laboratories, LLC | 58418-000 |
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