Over-the-counter drug · OTC MONOGRAPH DRUG
SPF 101 Lightly Tinted (Zinc oxide) NDC 85415-208
Zinc oxide 160 mg/g · Cream · Topical · The Acne Lab LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)85415-208Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85415-0208Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85415-208-15 | 85415020815 | 15 g in 1 PACKET (85415-208-15)Marketed from Jul 15, 2024 · Sample package |
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)
- SPF 101 Lightly Tinted
- Generic name (nonproprietary)
- zinc oxide
- Active ingredients
- Zinc oxide — 160 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- The Acne Lab LLCNDC labeler code 85415
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 020
- Marketing start
- Listing expires
- Identifiers
- Product ID 85415-208_4573f0fc-d57d-3f16-e063-6394a90ae433SPL ID 4573f0fc-d57d-3f16-e063-6394a90ae433SPL set ID 334d694a-f9e4-ae86-e063-6394a90abfe1UNII 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
N485415020815followed by a unit qualifier and the quantityPackage 85415-0208-15. 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 .
About NDC 85415-208
- What is NDC 85415-208?
- 85415-208 is the product NDC for SPF 101 Lightly Tinted (zinc oxide), Zinc oxide 160 mg/g cream, listed with the FDA by The Acne Lab LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- SPF 101 Lightly Tinted (Zinc Oxide).
- What is the active ingredient?
- Zinc oxide.
- Who is the labeler?
- The Acne Lab LLC, NDC labeler code 85415. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for SPF 101 Lightly Tinted?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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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