Over-the-counter drug · OTC MONOGRAPH DRUG
Coral Isle SPF 50 Mineral Sunscreen (Titanium dioxide, zinc oxide) NDC 49757-114
Titanium dioxide 4.5 g/100g; Zinc oxide 4 g/100g · Lotion · Topical · Rocky Mountain
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49757-114-02 | 4975701140249757011402 | 57 g in 1 BOTTLE (49757-114-02)Marketed from Jan 2, 2024 | |
| 49757-114-06 | 4975701140649757011406 | 170 g in 1 BOTTLE (49757-114-06)Marketed from Jan 2, 2024 |
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)
- Coral Isle SPF 50 Mineral Sunscreen
- Generic name (nonproprietary)
- titanium dioxide, zinc oxide
- Active ingredients
- Titanium dioxide — 4.5 g/100gZinc oxide — 4 g/100g
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Rocky MountainNDC labeler code 49757
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 020
- Marketing start
- Listing expires
- Identifiers
- Product ID 49757-114_5515f562-62da-c6ee-e063-6294a90a9ea6SPL ID 5515f562-62da-c6ee-e063-6294a90a9ea6SPL set ID 5515f562-62d9-c6ee-e063-6294a90a9ea6UNII 15FIX9V2JP, SOI2LOH54ZUPC 0754018850606, 0754018850200
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
N449757011402followed by a unit qualifier and the quantityPackage 49757-0114-02. 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)
Directions Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun protection measures: spending time n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including: limit time in the sun, especially from 10 am to 2 pm wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: ask a doctor.
Excerpt only. Read the full label for complete information.
About NDC 49757-114
- What is NDC 49757-114?
- 49757-114 is the product NDC for Coral Isle SPF 50 Mineral Sunscreen, Titanium dioxide 4.5 g/100g; Zinc oxide 4 g/100g lotion, listed with the FDA by Rocky Mountain. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Coral Isle SPF 50 Mineral Sunscreen (Titanium Dioxide, Zinc Oxide).
- What is the active ingredient?
- Titanium dioxide, Zinc oxide.
- Who is the labeler?
- Rocky Mountain, NDC labeler code 49757. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Coral Isle SPF 50 Mineral Sunscreen?
- 1 other product NDC are listed under this name. See all Coral Isle SPF 50 Mineral Sunscreen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Coral Isle SPF 50 Mineral Sunscreen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Coral Isle SPF 50 Mineral Sunscreentitanium dioxide, zinc oxide | Titanium dioxide 4.5 g/100g; Zinc oxide 4 g/100g | LotionTopical | Derma Care Research Labs, LLC | 72839-114 | 72839-0114-0272839-0114-0672839-0114-12+1 more |
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 |
|---|---|---|---|---|
| Walgreens Daily Facial Moisturizer with Broad Spectrum SPF 30 Sunscreenavobenzone, octisalate, octocrylene | Avobenzone 30 mg/mL + 2 more ingredients | LotionTopical | WALGREEN COMPANY | 0363-0172 |
| Walgreens 100 Sheer Broad Spectrum SPF 100avobenzone, homosalate, octisalate, octocrylene | Avobenzone 30 mg/mL + 3 more ingredients | LotionTopical | WALGREEN COMPANY | 0363-0228 |
| Radiance Foundation Broad Spectrum SPF 20 - Cappuccinooctinoxate, zinc oxide | Octinoxate 3 g/100mL; Zinc oxide 6.8 g/100mL | LiquidTopical | Distribuidora Comercial Jafra, S.A. de C.V. | 68828-735 |
| Sun Bum High Performance Sunscreen Signature Clear 50 Newoctocrylene, octisalate, zinc oxide | Octisalate 50 mg/mL + 2 more ingredients | LotionTopical | Sun Bum, LLC | 69039-708 |
| Scentual Aroma Beauty Sun Veil SPF30titanium dioxide, zinc oxide | Titanium dioxide 2 g/100g; Zinc oxide 18.4 g/100g | CreamTopical | LABORATOIRES DRUIDE INC | 71447-056 |
| Crunchi Sunlight Tinted Sunscreen SPF 30 Mediumzinc oxide | Zinc oxide 940 mg/mL | LiquidTopical | Crunchi, LLC. | 72444-0204 |
| Farmasi BB Beauty Balm Cream SPF 15- 01 Lighttitanium dioxide | Titanium dioxide 35 mg/mL | CreamTopical | Farmasi US LLC | 74690-040 |
| Hydrating Glow Mist SPF 50avobenzone, octisalate, octocrylene | Avobenzone 3 g/100mL + 3 more ingredients | SprayTopical | NAKED SUNDAYS PTY LTD | 81104-102 |
| COOLA SunBlur Makeup Mist SPF 50avobenzone, homosalate, octisalate, octocrylene | Octocrylene 80 mg/mL + 3 more ingredients | SprayTopical | COOLA LLC | 79753-107 |
| spf 50 mineral powder sunscreentitanium dioxide, zinc oxide | Titanium dioxide 23.9 g/100g; Zinc oxide 24.1 g/100g | PowderTopical | Smalls Brand LLC DBA Roe Wellness | 83369-001 |
| Odacite Nourishing Lip Serum - Jazzy Berryzinc oxide | Zinc oxide 132 mg/mL | LotionTopical | Odacite | 82088-876 |
| Visor Clear Body Oil-Free Sunscreen SPF 50avobenzone, homosalate, octisalate, octocrylene | Avobenzone 30 mg/mL + 3 more ingredients | GelTopical | VISOR SKINCARE LLC | 85335-589 |
| Non Tinted Mineral Sunscreen Sticktitanium dioxide, zinc oxide | Titanium dioxide 40 mg/g; Zinc oxide 55 mg/g | StickTopical | Hirschman, Kristina | 85414-219 |
| Headhunter Surf Screen SPF 50 Sunscreenzinc oxide,titanium dioxide | Titanium dioxide 5.6 mg/100mL; Zinc oxide 11 mg/100mL | CreamTopical | Guangzhou Tata Biotechnology Co., Ltd. | 84066-107 |
| Olay Complete plus Facial Moisturizer with Sunscreen Broad Spectrum SPF 40 Sensitiveavobenzone, homosalate, octisalate, and octocrylene | Avobenzone 3 g/100mL + 3 more ingredients | LotionTopical | The Procter & Gamble Manufacturing Company | 84126-232 |
| Orlaskin Hydrating Sunscreen SPF 50octocrylene ethylhexyl methoxycinnamate ethylhexyl salicylate avobenzone | Octocrylene 10 g/100mL + 3 more ingredients | SprayTopical | Guangzhou Yapheon Health Industry Co., Ltd. | 87582-004 |
| Luxe Gloss Hydrating Lip Gloss SPF 35-ICED OUToctocrylene 8%, octisalate 5%, titanium dioxide 6%, zinc oxide 8% | Octocrylene .08 g/mL + 3 more ingredients | CreamTopical | Lale Cosmetics LLC | 87911-003 |
| 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 |
| Reunited Lipgloss SPF 30 - WALKING ON SUNSHINEhomosalate, octocrylene, octisalate | Homosalate 8 g/100mL + 2 more ingredients | LiquidTopical | Princeville Productions, LLC, DBA Reunited Beauty | 87326-002 |
| Banana Boat Baby Mineral Enriched Sunscreen UVA/UVB Protection Broad Spectrum SPF 50PLUShomosalate,octisalate,octocrylene,zinc oxide | Octocrylene 6 g/100g + 3 more ingredients | LotionTopical | Edgewell Personal Care Brands LLC | 63354-682 |
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