Over-the-counter drug · OTC MONOGRAPH NOT FINAL
Age Renewal Firming NDC 68634-063
octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide · Octinoxate 60 mg/g + 4 more ingredients · Lotion · Topical · AMCOL Health & Beauty Solutions, Inc. DBA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68634-063-01 | 68634006301 | 1 BOTTLE in 1 CARTON (68634-063-01) / 51 g in 1 BOTTLEMarketed from Oct 1, 2014 |
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)
- Age Renewal Firming
- Generic name (nonproprietary)
- octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide
- Active ingredients
- Octinoxate — 60 mg/gOctisalate — 50 mg/gOxybenzone — 40 mg/gTitanium dioxide — 39 mg/gZinc oxide — 20 mg/g
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- AMCOL Health & Beauty Solutions, Inc. DBANDC labeler code 68634
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (not final)Application part352
- Marketing start
- Listing expires
- Identifiers
- Product ID 68634-063_13aca11f-558b-4916-b2fa-6c87d34c5abbSPL ID 13aca11f-558b-4916-b2fa-6c87d34c5abbSPL set ID 6cb27f87-40a3-4049-aded-eb788509c575UNII 4Y5P7MUD51, 4X49Y0596W, 95OOS7VE0Y, 15FIX9V2JP, 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
N468634006301followed by a unit qualifier and the quantityPackage 68634-0063-01. 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 cause by the sun.
Excerpt only. Read the full label for complete information.
About NDC 68634-063
- What is NDC 68634-063?
- 68634-063 is the product NDC for Age Renewal Firming, Octinoxate 60 mg/g + 4 more ingredients lotion, listed with the FDA by AMCOL Health & Beauty Solutions, Inc. DBA. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Age Renewal Firming (Octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide).
- What is the active ingredient?
- Octinoxate, Octisalate, Oxybenzone, Titanium dioxide, Zinc oxide.
- Who is the labeler?
- AMCOL Health & Beauty Solutions, Inc. DBA, NDC labeler code 68634. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Age Renewal Firming?
- 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 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 Mediumtitanium dioxide, octinoxate, octisalate | Octinoxate 2.1 mg/30mL + 2 more ingredients | CreamTopical | KW ABSC, INC. | 69231-025 |
| 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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