Over-the-counter drug · OTC MONOGRAPH DRUG
SPF 30 Sunscreen (Zinc oxide, titanium dioxide) NDC 83294-101
Zinc oxide 9 g/100mL; Titanium dioxide 4.51 g/100mL · Lotion · Topical · CLEURE
NDC codes
FDA NDC DirectoryProduct NDC (as listed)83294-101Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83294-0101Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83294-101-18 | 83294010118 | 118 mL in 1 TUBE (83294-101-18)Marketed from Aug 22, 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)
- SPF 30 Sunscreen
- Generic name (nonproprietary)
- zinc oxide, titanium dioxide
- Active ingredients
- Zinc oxide — 9 g/100mLTitanium dioxide — 4.51 g/100mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- CLEURENDC labeler code 83294
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 020
- Marketing start
- Listing expires
- Identifiers
- Product ID 83294-101_471ab663-50b0-9e95-e063-6294a90a6115SPL ID 471ab663-50b0-9e95-e063-6294a90a6115SPL set ID f5512f34-08ee-b0f6-e053-2a95a90ab5bdUNII SOI2LOH54Z, 15FIX9V2JP
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
N483294010118followed by a unit qualifier and the quantityPackage 83294-0101-18. 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 measutes 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 83294-101
- What is NDC 83294-101?
- 83294-101 is the product NDC for SPF 30 Sunscreen, Zinc oxide 9 g/100mL; Titanium dioxide 4.51 g/100mL lotion, listed with the FDA by CLEURE. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- SPF 30 Sunscreen (Zinc Oxide, Titanium Dioxide).
- What is the active ingredient?
- Zinc oxide, Titanium dioxide.
- Who is the labeler?
- CLEURE, NDC labeler code 83294. 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 30 Sunscreen?
- 5 other product NDCs are listed under this name. See all SPF 30 Sunscreen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other SPF 30 Sunscreen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| SPF 30 Sunscreenhomosalate 10% octisalate 5% avobenzone 3% | Homosalate 10 g/100mL + 2 more ingredients | SprayTopical | Coconut Caliente Costa Rica LLC | 85033-005 | 85033-0005-04 |
| SPF 30 Sunscreenhomosalate 10% octisalate 5% avobenzone 3% | Homosalate 10 g/100mL + 2 more ingredients | SprayTopical | Coconut Caliente Costa Rica LLC | 85033-003 | 85033-0003-04 |
| SPF 30 Sunscreenavobenzone, homosalate, octocrylene, octisalate | Avobenzone 30 mg/mL + 3 more ingredients | LotionTopical | Tekweld Solutions, Inc. | 71160-331 | 71160-0331-3071160-0331-3171160-0331-32+1 more |
| SPF 30 Sunscreenavobenzone, homosalate, octocrylene, octisalate | Avobenzone 30 mg/mL + 3 more ingredients | LotionTopical | Tekweld Solutions, Inc. | 71160-338 | 71160-0338-10 |
| SPF 30 Sunscreenavobenzone, homosalate, octisalate, octocrylene | Homosalate 15 g/100g + 3 more ingredients | SprayTopical | Derma Care Research Labs, LLC | 72839-165 | 72839-0165-0672839-0165-1672839-0165-26+1 more |
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 |
|---|---|---|---|---|
| Vacation Superavobenzone homosalate octisalate octocrylene | Octocrylene 8.6 g/100g + 3 more ingredients | StickTopical | Vacation Inc. | 80641-017 |
| Naturium UV Reflect Antioxidant SPF 50homosalate, octisalate, avobenzone | Avobenzone 30 mg/mL + 2 more ingredients | LotionTopical | e.l.f. Cosmetics, Inc | 76354-125 |
| Ilia Super Serum Skin Tint (St17.5 Perissa)zinc oxide | Zinc oxide 132 mg/mL | LotionTopical | Ilia, Inc. | 81110-059 |
| Sunscreen for Face SPF50non nano zinc oxide | Zinc oxide 10.4 g/40mL | CreamTopical | SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI | 82123-016 |
| Cay Skin MoBay Mineral Sunscreen Drops SPF 30zinc oxide | Zinc oxide 94 mg/mL | LotionTopical | Cay Skin, Inc. | 82657-008 |
| Laura Mercier Tinted Moisturizer Light Revealer Natural Skin Illuminator Broad Spectrum SPF 25 Sunscreen 3W1 Bisqueavobenzone, homosalate, octisalate, and octocrylene | Avobenzone 1.53 g/50mL + 3 more ingredients | CreamTopical | Laura Mercier US Buyer LLC | 82761-008 |
| SPF30 unseen sunscreen stick 01avobenzone, homosalate, octocrylene, octisalate | Avobenzone 3 g/100g + 3 more ingredients | StickTopical | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 82953-047 |
| Basin Coconut SPF 30 Lip Balm SPF 30avobenzone, octinoxate, octisalate, oxybenzone | Octinoxate 7.5 g/100g + 3 more ingredients | StickTopical | Retail Concepts of Minnesota, Inc. | 84603-172 |
| Rms Suncoverup Super Tint SPF 50 Buffzinc oxide | Zinc oxide 120 mg/mL | LotionTopical | Rms organics LLC | 83249-005 |
| Florida Glow SPF 30avobenzone,octocrylene,octisalate,homosalate | Avobenzone 3 g/100mL + 3 more ingredients | SprayTopical | Southeast Holdings Corp. | 83862-002 |
| Black Girl Sunscreen Sunscreen SPF 30 broad Spectrumavobenzone, homosalate, octisalate, octocrylene | Avobenzone 29.4 mg/mL + 3 more ingredients | LotionTopical | Black Girl Sunscreen, LLC | 84204-0010 |
| Minicell UV Shield Sunscreenavobenzone, homosalate, octisalate, octocrylene | Octocrylene 3 g/50g + 3 more ingredients | CreamTopical | CELINA CO., LTD. | 87287-150 |
| Vitaran Rejuvena Suncareallantoin, avobenzone, homosalate, octisalate | Homosalate 13.5 g/100g + 3 more ingredients | CreamTopical | BR PHARM CO. , Ltd. | 87435-1000 |
| Haruharu Wonder - Centella Calm Cloud SPFavobenzone, homosalate, octisalate, octocrylene | Octisalate 4.5 g/100g + 3 more ingredients | CreamTopical | DFS Company | 87557-002 |
| Florida Babe Sport Tinted Mineral Sunscreentitanium dioxide, zinc oxide | Zinc oxide 38 mg/g; Titanium dioxide 80 mg/g | CreamTopical | Tichy Anesthesia PA | 85337-203 |
| SPF 101 Non-Tintedzinc oxide | Zinc oxide 160 mg/g | CreamTopical | The Acne Lab LLC | 85415-226 |
| Replenishing Daily Protection Tintedzinc oxide | Zinc oxide 160 mg/g | CreamTopical | YUMA ACNE CLINIC, L.L.C. | 87003-208 |
| Sunscreenbroad spectrum spf 30 | Octocrylene 5 g/100g + 2 more ingredients | SprayTopical | Charleston Dermatology, P.C. | 87901-3019 |
| NARS PURE RADIANT TINTED MOISTURIZER Marrakeshoctinoxate, titanium dioxide | Octinoxate 4.044 g/50mL; Titanium dioxide 3.996 g/50mL | CreamTopical | NARS Cosmetics | 13734-188 |
| Lbel Solutions Pro-Hialuron Base Serum Efecto Relleno De Arrugas Fps 15 Wrinkle Filler Effect Serum Foundation SPF 15 Champagne 170-Noctinoxate, zinc oxide | Zinc oxide 29.4 mg/mL; Octinoxate 45 mg/mL | EmulsionTopical | BEL STAR S.A. | 14141-599 |
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