Over-the-counter drug · OTC MONOGRAPH DRUG
Australian Gold SPF 15 Lip Balm NDC 84061-128
octinoxate, octocrylene, oxybenzone, octisalate, petroleum jelly · Octinoxate 7.5 mg/g + 4 more ingredients · Stick · Topical · Australian Gold
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84061-128-01 | 8406101280184061012801 | 1 g in 1 CONTAINER (84061-128-01)Marketed from Jan 1, 2025 |
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)
- Australian Gold SPF 15 Lip Balm
- Generic name (nonproprietary)
- octinoxate, octocrylene, oxybenzone, octisalate, petroleum jelly
- Active ingredients
- Octinoxate — 7.5 mg/gOxybenzone — 5 mg/gPetrolatum — 30 mg/gOctocrylene — 7 mg/gOctisalate — 5 mg/g
- Dosage form
- Stick
- Route
- Topical
- Labeler
- Australian GoldNDC labeler code 84061
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 020
- Marketing start
- Listing expires
- Identifiers
- Product ID 84061-128_49020aaa-0208-4943-e063-6394a90abaefSPL ID 49020aaa-0208-4943-e063-6394a90abaefSPL set ID 92966c2d-b61a-4f8b-a5c1-8dfb6352c82fUNII 4Y5P7MUD51, 95OOS7VE0Y, 4T6H12BN9U, 5A68WGF6WM, 4X49Y0596W
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
N484061012801followed by a unit qualifier and the quantityPackage 84061-0128-01. 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 Prevents Sunburns
Excerpt only. Read the full label for complete information.
About NDC 84061-128
- What is NDC 84061-128?
- 84061-128 is the product NDC for Australian Gold SPF 15 Lip Balm, Octinoxate 7.5 mg/g + 4 more ingredients stick, listed with the FDA by Australian Gold. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Australian Gold SPF 15 Lip Balm (Octinoxate, Octocrylene, Oxybenzone, Octisalate, Petroleum Jelly).
- What is the active ingredient?
- Octinoxate, Oxybenzone, Petrolatum, Octocrylene, Octisalate.
- Who is the labeler?
- Australian Gold, NDC labeler code 84061. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Australian Gold SPF 15 Lip Balm?
- 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 |
|---|---|---|---|---|
| bareMinerals Original Foundation Broad Spectrum SPF 15 Light 08titanium dioxide and zinc oxide | Titanium dioxide 1440 mg/8g; Zinc oxide 1760 mg/8g | PowderTopical | Orveon Global US LLC | 98132-010 |
| BelleJoss BROAD SPECTRUM SPF 50broad spectrum spf 50 | Ethylhexyl methoxycinnamate 7.4925 mg/100mg | CreamTopical | Guangzhou Liyan Cosmetics Technology Co., Ltd. | 87770-002 |
| Mineral Based Foam Sunscreen Non-Tintedtitanium dioxide, zinc oxide | Titanium dioxide 30 mg/g; Zinc oxide 100 mg/g | Aerosol, FoamTopical | KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION | 81679-211 |
| COOLA Classic Body SPF 50 Guava Mangoavobenzone, homosalate, octisalate, octocrylene | Avobenzone 2.9 g/100mL + 3 more ingredients | SprayTopical | COOLA, LLC | 79753-059 |
| Golden Rose Glow Kiss Tinted Lip Balm Vanilla Latteavobenzone, octinoxate | Avobenzone 2.7 g/100g; Octinoxate 6 g/100g | LipstickTopical | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 82715-109 |
| Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tintedzinc oxide | Zinc oxide 160 mg/g | CreamTopical | NY BEAUTY PALACE LLC | 85404-208 |
| Tinted Mineral Sunscreentitanium dioxide, zinc oxide | Titanium dioxide 80 mg/g; Zinc oxide 38 mg/g | CreamTopical | The Essential Brazilian Spa LLC | 85492-203 |
| Tinted Sunscreentitanium dioxide, zinc oxide | Titanium dioxide 80 mg/g; Zinc oxide 38 mg/g | CreamTopical | Scottsdale Skin Boutique and Dermatology Pllc | 85331-203 |
| First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30zinc oxide | Zinc oxide 22 g/100mL | LiquidTopical | The Procter & Gamble Manufacturing Company | 84126-214 |
| the beach people SPF 15zinc oxide | Zinc oxide 12 g/100mL | LotionTopical | The Beach People United LLC | 84530-100 |
| Tinted Sunscreen Broad SPF30 | Zinc oxide 7.5 g/100g; Titanium dioxide 3.2 g/100g | CreamTopical | DOSCHER FAMILY HEALTH NP P.C. | 84608-0651 |
| Flawless Future SPF 30octinoxate, octisalate, oxybenzone, avaobenzone | Octinoxate 7.14 mg/g + 3 more ingredients | EmulsionTopical | REVLON | 10967-683 |
| Lbel Forever Matte Base Control Brillo Y Larga Duracion 48H Fps 15 Control And Longwear Foundation 48H SPF 15 Latte 180-Foctinoxate, zinc oxide | Octinoxate 50 mg/g; Zinc oxide 49 mg/g | EmulsionTopical | BEL STAR S.A. | 14141-342 |
| Pro-Tect Sports Sunscreenmeradimate, octinoxate, octisalate, oxybenzone | Octinoxate 75 mg/g + 3 more ingredients | LotionCutaneous | Bio-Medical & Pharmaceutical Manufacturing Corporation | 37945-862 |
| ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30titanium dioxide and zinc oxide | Titanium dioxide 10 mg/mL; Zinc oxide 200 mg/mL | CreamTopical | ZO Skin Health, Inc. | 42851-060 |
| Artistry Exact Fit Longwearing Foundation Shade Golden L4N1titanium dioxide | Titanium dioxide 40.25 mg/mL | CreamTopical | Amway Corp | 50390-205 |
| Derma B Everyday Fit Sunscreen SPF 50avobezone, homosalate, octisalate, octocrylene | Avobenzone 30 mg/mL + 3 more ingredients | LotionTopical | NeoPharm Co., Ltd. | 51141-0701 |
| Cell Fusion C Laser UV Defense Sunscreen Broad Spectrum SPF 50homosalate, octisalate, octocrylene, zinc oxide | Homosalate 6 g/50mL + 3 more ingredients | CreamTopical | CMS LAB Inc. | 52554-9062 |
| SPF 30 Sunscreenavobenzone, homosalate, octisalate, octocrylene | Avobenzone 30 mg/g + 3 more ingredients | Aerosol, SprayTopical | DEMOULAS SUPER MARKETS, INC | 53942-002 |
| Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Ivorytitanium dioxide and zinc oxide | Titanium dioxide 50 mg/mL; Zinc oxide 50 mg/mL | CreamTopical | PML NYC, LLC | 59735-900 |
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