Over-the-counter drug · OTC MONOGRAPH DRUG
Alpha-H Total Eclipse (Titanium dioxide, zinc oxide) NDC 55528-400
Zinc oxide 9.7 mg/mL; Titanium dioxide 19.4 mg/mL · Lotion · Topical · Alpha-H
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55528-400-02 | 55528040002 | 1 TUBE in 1 CARTON (55528-400-02) / 40 mL in 1 TUBE (55528-400-01)Marketed from May 5, 2023 |
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)
- Alpha-H Total Eclipse
- Generic name (nonproprietary)
- titanium dioxide, zinc oxide
- Active ingredients
- Zinc oxide — 9.7 mg/mLTitanium dioxide — 19.4 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Alpha-HNDC labeler code 55528
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 020
- Marketing start
- Listing expires
- Identifiers
- Product ID 55528-400_43908af3-3a7d-4e13-e063-6394a90a47c2SPL ID 43908af3-3a7d-4e13-e063-6394a90a47c2SPL set ID fc8a4efe-7d5e-5f44-e053-6394a90a80aaUNII 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
N455528040002followed by a unit qualifier and the quantityPackage 55528-0400-02. 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)
Alpha-H Total Eclipse Indications & usage
Excerpt only. Read the full label for complete information.
About NDC 55528-400
- What is NDC 55528-400?
- 55528-400 is the product NDC for Alpha-H Total Eclipse, Zinc oxide 9.7 mg/mL; Titanium dioxide 19.4 mg/mL lotion, listed with the FDA by Alpha-H. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alpha-H Total Eclipse (Titanium dioxide, Zinc Oxide).
- What is the active ingredient?
- Zinc oxide, Titanium dioxide.
- Who is the labeler?
- Alpha-H, NDC labeler code 55528. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alpha-H Total Eclipse?
- 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 |
|---|---|---|---|---|
| Naturium Phyto-Glow Lip Balm SPF 45-Getawayavobenzone, homosalate, octisalate | Avobenzone 30 mg/mL + 2 more ingredients | CreamTopical | e.l.f. Cosmetics, Inc. | 76354-136 |
| Laura Mercier Tinted Moisturizer Natural Skin Perfector Broad Spectrum SPF 30 Sunscreen 2N1 Nudeavobenzone, octinoxate, octocrylene, and oxybenzone | Avobenzone 1.25 g/50mL + 3 more ingredients | CreamTopical | Laura Mercier US Buyer LLC | 82761-037 |
| Black Girl Sunscreen SPF 45avobenzone, homosalate, octisalate, octocrylene | Homosalate 79 mg/mL + 3 more ingredients | GelTopical | Black Girl Sunscreen, LLC | 84204-0005 |
| Rms Suncoverup Super Tint SPF 50 Honeyzinc oxide | Zinc oxide 120 mg/mL | LotionTopical | Rms organics LLC | 83249-008 |
| Basin Peach Apricot SPF 15 Broad Spectrum Sunscreen Lip Balmavobenzone, octinoxate, octisalate, octocrylene | Octinoxate 7.5 g/100g + 3 more ingredients | StickTopical | Retail Concepts of Minnesota, Inc. | 84603-120 |
| Linozinc oxide | Zinc oxide 24 g/100g | CreamTopical | Lino Cosmetics LLC | 84749-001 |
| Ultimate Physical Sunscreenzinc oxide | Zinc oxide 200 mg/g | CreamTopical | HALEM DERMATOLOGY PLLC | 85413-205 |
| Mineral Lip Sunscreentitanium dioxide, zinc oxide | Titanium dioxide 40 mg/g; Zinc oxide 38 mg/g | StickTopical | CAPE COD SKIN CARE CO. INC. | 85627-212 |
| UV Defense Mineral Sunscreen Tintedtitanium dioxide, zinc oxide | Zinc oxide 38 mg/g; Titanium dioxide 80 mg/g | CreamTopical | CCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC | 85495-203 |
| Broad Spectrum SPF 50 Sunscreenzinc oxide | Zinc oxide 235 mg/mL | LotionTopical | SKIN DAMAGE INC. | 87693-001 |
| bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Tan 18titanium dioxide and zinc oxide | Titanium dioxide 688 mg/8g; Zinc oxide 2000 mg/8g | PowderTopical | Orveon Global US LLC | 98132-011 |
| Radiant Defense Perfecting Liquid Broad Spectrum SPF 30 - Sandtitanium dioxide, zinc oxide | Titanium dioxide 3.44 g/100mL; Zinc oxide 4 g/100mL | LotionTopical | Rodan & Fields | 14222-2033 |
| Artistry Exact Fit Longwearing Foundation Shade Natural L2N2titanium dioxide | Titanium dioxide 40.25 mg/mL | CreamTopical | Amway Corp | 50390-213 |
| Shiseido Benefiance Wrinkle Smoothing Dayavobenzone, homosalate, octisalate, and octocrylene | Avobenzone 1.295 g/50mL + 3 more ingredients | CreamTopical | Shiseido Americas Corporation | 58411-017 |
| Shiseido Revitalessence Skin Glow Foundation 360octinoxate | Octinoxate 2.30805 g/30mL | EmulsionTopical | SHISEIDO AMERICAS CORPORATION | 58411-876 |
| Sei Bella Tinted BB Moisturizing Cream410 n | Titanium dioxide 1.5 g/30mL; Zinc oxide 1.5 g/30mL | LotionTopical | PML NYC, LLC | 59735-892 |
| glo Skin Beauty C-Shield Anti-Pollution Moisture Tint Broad Spectrum SPF 30 | Avobenzone 3 g/100g + 2 more ingredients | CreamTopical | Hayden Caleel LLC | 60541-2000 |
| Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1CR Cool Fosyoctisalate, titanium dioxide | Octisalate 45 mg/mL; Titanium dioxide 42.3 mg/mL | EmulsionTopical | Parfums Christian Dior | 61957-3209 |
| BB Bronze 30 BS SPF30zinc oxide and titanium dioxide | Titanium dioxide 6.8 g/100g; Zinc oxide 8.5 g/100g | CreamTopical | Allure Labs | 62742-4248 |
| Bath and Body Works SPF Waikiki Beach Coconutavobenzone,homosalate,octisalate,octocrylene | Octocrylene 10 mg/100mg + 3 more ingredients | SprayTopical | Bath & Body Works, Inc. | 62670-6689 |
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