Over-the-counter drug · OTC MONOGRAPH NOT FINAL
CLE CCC Warm Medium (Titanium dioxide, octinoxate, octisalate) NDC 69231-025
Octinoxate 2.1 mg/30mL + 2 more ingredients · Cream · Topical · KW ABSC, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69231-025-02 | 69231002502 | 1 CONTAINER in 1 PACKAGE (69231-025-02) / 30 mL in 1 CONTAINER (69231-025-01)Marketed from Nov 27, 2018 |
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)
- CLE CCC Warm Medium
- Generic name (nonproprietary)
- titanium dioxide, octinoxate, octisalate
- Active ingredients
- Octinoxate — 2.1 mg/30mLOctisalate — .9 mg/30mLTitanium dioxide — 2.52846 mg/30mL
- Dosage form
- Cream
- Route
- Topical
- Labeler
- KW ABSC, INC.NDC labeler code 69231
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (not final)Application part352
- Marketing start
- Listing expires
- Identifiers
- Product ID 69231-025_7baea303-1384-5a69-e053-2991aa0a5f54SPL ID 7baea303-1384-5a69-e053-2991aa0a5f54SPL set ID b585f216-4234-47c5-9a6b-8b133ef48aaeUNII 4Y5P7MUD51, 4X49Y0596W, 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
N469231002502followed by a unit qualifier and the quantityPackage 69231-0025-02. 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)
Helps prevent sunburn
Excerpt only. Read the full label for complete information.
About NDC 69231-025
- What is NDC 69231-025?
- 69231-025 is the product NDC for CLE CCC Warm Medium, Octinoxate 2.1 mg/30mL + 2 more ingredients cream, listed with the FDA by KW ABSC, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CLE CCC Warm Medium (Titanium Dioxide, Octinoxate, Octisalate).
- What is the active ingredient?
- Octinoxate, Octisalate, Titanium dioxide.
- Who is the labeler?
- KW ABSC, INC., NDC labeler code 69231. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CLE CCC Warm Medium?
- 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 |
|---|---|---|---|---|
| 100% Pure Yerba Mate MIst SPF 30zinc oxide | Zinc oxide 120 mg/mL | Aerosol, SprayTopical | Purity Cosmetics | 52667-006 |
| Academy SPF 50avobenzone, homosalate, octisalate, octocrylene, oxybenzone | Avobenzone 1.5 g/100g + 4 more ingredients | LotionTopical | ACADEMY, LTD | 59054-880 |
| Advanced Anti-Wrinkle Therapy Cicatricureavobenxone 3%, octinoxate 7.5%, octisalate 5%, octocrylene 2.7%, oxybenzone 4% | Avobenzone 3 g/100g + 4 more ingredients | CreamTopical | Genomma Lab | 50066-021 |
| Age Renewal Firmingoctinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide | Octinoxate 60 mg/g + 4 more ingredients | LotionTopical | AMCOL Health & Beauty Solutions, Inc. DBA | 68634-063 |
| Age Renewal Firming and Hydrating Moisturizer SPF 30octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide | Octinoxate 60 mg/g + 4 more ingredients | LotionTopical | CVS Health | 69842-067 |
| All Weather SPF 15 Lip Balmzinc oxide | Zinc oxide 11 g/100g | StickTopical | Burt's Bees | 26052-036 |
| Amish Origins SPF 15 Lip Balmoctinoxate, octocrylene, oxybenzone | Octinoxate 7.5 mg/g + 2 more ingredients | StickTopical | Amish Origins | 62212-350 |
| Beauty 360 Accelerated Wrinkle Repair Moisturizerhomosalate, octisalate, avobenzone, octocrylene | Homosalate 40 g/2mL + 3 more ingredients | LiquidTopical | AMCOL Health & Beauty Solutions, Inc. DBA | 68634-054 |
| Beauty 360 Accelerated Wrinkle Repair Moisturizerhomosalate, octisalate, avobenzone, octocrylene | Homosalate 40 mg/mL + 3 more ingredients | LiquidTopical | CVS Health | 69842-080 |
| Broad Spectrum SPF 30 for Face and Bodyzinc oxide | Zinc oxide 186 mg/g | CreamTopical | Allure Labs Inc | 62742-4116 |
| CLE CCC Golden Medium Deeptitanium dioxide, octinoxate, octisalate | Octinoxate 2.1 mg/30mL + 2 more ingredients | CreamTopical | KW ABSC, INC. | 69231-027 |
| CLE CCC Warm Lighttitanium dioxide, octinoxate, octisalate | Octinoxate 2.1 mg/30mL + 2 more ingredients | CreamTopical | KW ABSC, INC. | 69231-023 |
| CLE CCC Warm Medium Deeptitanium dioxide, octinoxate, octisalate | Octinoxate 2.1 mg/30mL + 2 more ingredients | CreamTopical | KW ABSC, INC. | 69231-026 |
| CLE CCC Warm Medium Lighttitanium dioxide, octinoxate, octisalate | Octinoxate 2.1 mg/30mL + 2 more ingredients | CreamTopical | KW ABSC, INC. | 69231-024 |
| 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 |
| 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 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 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 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 Taupezinc oxide and titanium dioxide | Zinc oxide 85 mg/mL; Titanium dioxide 65 mg/mL | CreamTopical | Allure Labs, Inc | 62742-4124 |
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