Over-the-counter drug · OTC MONOGRAPH DRUG
Xbalm Extreme Orange (Octinoxate and oxybenzone) NDC 10827-2004
Octinoxate .294 g/4.2g; Oxybenzone .168 g/4.2g · Stick · Topical · Yusef Manufacturing Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10827-2004-1 | 1082720040110827200401 | 4.2 g in 1 TUBE (10827-2004-1)Marketed from Jan 1, 2006 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Xbalm Extreme Orange
- Generic name (nonproprietary)
- octinoxate and oxybenzone
- Active ingredients
- Octinoxate — .294 g/4.2gOxybenzone — .168 g/4.2g
- Dosage form
- Stick
- Route
- Topical
- Labeler
- Yusef Manufacturing LaboratoriesNDC labeler code 10827
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication part352
- Marketing start
- Listing expires
- Identifiers
- Product ID 10827-2004_5f8e2cc3-40a0-f5fa-e063-6394a90ae837SPL ID 5f8e2cc3-40a0-f5fa-e063-6394a90ae837SPL set ID 9d55cab7-5cd6-4c07-abb7-45de8d0d5fb6UNII 4Y5P7MUD51, 95OOS7VE0YUPC 0850523001011
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
N410827200401followed by a unit qualifier and the quantityPackage 10827-2004-01. 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 • Higher SPF gives more sunburn protection.
Excerpt only. Read the full label for complete information.
About NDC 10827-2004
- What is NDC 10827-2004?
- 10827-2004 is the product NDC for Xbalm Extreme Orange, Octinoxate .294 g/4.2g; Oxybenzone .168 g/4.2g stick, listed with the FDA by Yusef Manufacturing Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xbalm Extreme Orange (Octinoxate and oxybenzone).
- What is the active ingredient?
- Octinoxate, Oxybenzone.
- Who is the labeler?
- Yusef Manufacturing Laboratories, NDC labeler code 10827. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xbalm Extreme Orange?
- 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 part352
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 |
|---|---|---|---|---|
| Meijer SPF 8avobenzone, octocrylene, oxybenzone | Avobenzone .9 g/100g + 2 more ingredients | LotionTopical | Meijer Distribution Inc | 41250-360 |
| Meijer Kids Tear Free SPF 50avobenzone, homosalate, octisalate, octocrylene | Avobenzone 3 g/100g + 3 more ingredients | SprayTopical | Meijer Distribution, Inc. | 41250-928 |
| Meijer Sport SPF 30avobenzone, homosalate, octisalate, octocrylene | Avobenzone 3 g/100g + 3 more ingredients | LotionTopical | Meijer Distribution, Inc. | 41250-924 |
| Meijer Sport SPF 50avobenzone, homosalate, octisalate, octocrylene, oxybenzone | Avobenzone 3 g/100g + 4 more ingredients | LotionTopical | Meijer Distribution, Inc. | 41250-925 |
| SheerZinc SPF 30 Tinted - SunKissedzinc oxide | Zinc oxide 186 mg/g | CreamTopical | Allure Labs Inc | 62742-4094 |
| SheerZinc SPF 30 Tinted - Tanzinc oxide | Zinc oxide 186 mg/g | CreamTopical | Allure Labs Inc | 62742-4095 |
| SheerZinc SPF 30 Tinted - Nudezinc oxide | Zinc oxide 186 mg/g | CreamTopical | Allure Labs Inc | 62742-4108 |
| Glossier sun glaze gleaming sunscreen oil broad spectrum SPF 30 Water Resistant 40 Min | Avobenzone 3 g/100g + 3 more ingredients | Aerosol, SprayTopical | Glossier Inc. | 71425-030 |
| Light Tint Clear Zinc Solar Protection SPF 30zinc oxide | Zinc oxide 170 mg/g | CreamTopical | Allure Labs, Inc | 62742-4110 |
| Tinted Clear Zinc Solar Protection SPF 30zinc oxide | Zinc oxide 176.7 mg/g | CreamTopical | Allure Labs, Inc | 62742-4112 |
| Cover Recover SPF 30 Beigezinc oxide and titanium dioxide | Zinc oxide 85 mg/mL; Titanium dioxide 65 mg/mL | CreamTopical | Allure Labs, Inc | 62742-4119 |
| Broad Spectrum SPF 30 for Face and Bodyzinc oxide | Zinc oxide 186 mg/g | CreamTopical | Allure Labs Inc | 62742-4116 |
| SkinPerfect Primer SPF 30titanium dioxide and zinc oxide | Titanium dioxide 40 mg/mL; Zinc oxide 140 mg/mL | LotionTopical | Dermalogica, Inc. | 68479-130 |
| Cover Recover SPF 30 Ivoryzinc oxide and titanium dioxide | Zinc oxide 85 mg/mL; Titanium dioxide 65 mg/mL | CreamTopical | Allure Labs, Inc | 62742-4117 |
| Cover Recover SPF 30 Creamzinc oxide and titanium dioxide | Zinc oxide 85 mg/mL; Titanium dioxide 65 mg/mL | CreamTopical | Allure Labs, Inc | 62742-4118 |
| Cover Recover SPF 30 Sandzinc oxide and titanium dioxide | Zinc oxide 85 mg/mL; Titanium dioxide 65 mg/mL | CreamTopical | Allure Labs, Inc | 62742-4123 |
| Cover Recover SPF 30 Cocoazinc oxide and titanium dioxide | Zinc oxide 85 mg/mL; Titanium dioxide 65 mg/mL | CreamTopical | Allure Labs, Inc | 62742-4120 |
| Cover Recover SPF 30 Tawnyzinc oxide and titanium dioxide | Zinc oxide 85 mg/mL; Titanium dioxide 65 mg/mL | CreamTopical | Allure Labs, Inc | 62742-4121 |
| Cover Recover SPF 30 Warm Beigezinc oxide and titanium dioxide | Zinc oxide 85 mg/mL; Titanium dioxide 65 mg/mL | CreamTopical | Allure Labs, Inc | 62742-4122 |
| Mineral Sunscreen Broad Spectrum SPF 45zinc oxide and titanium dioxide | Zinc oxide 51.4 mg/mL; Titanium dioxide 73.6 mg/mL | CreamTopical | Allure Labs, Inc | 62742-4152 |
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