SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredients
Homosalate 0.10mL / 1mL
Octinoxate 0.075mL / 1mL
Octisalate 0.05mL / 1mL
Octocrylene 0.05mL / 1mL
Avobenzone 0.03mL / 1mL
Drug Facts
Active Ingredients
Homosalate 0.10mL / 1mL
Octinoxate 0.075mL / 1mL
Octisalate 0.05mL / 1mL
Octocrylene 0.05mL / 1mL
Avobenzone 0.03mL / 1mL
Aplíque generosamente o libremente media hora antes de la exposición al sol y como sea necesario. Para mantener la protección, repita cada dos horas al transpirar, bañarse, o secarse. Es necesario reiterar la aplicación para mantener la efectividad del producto.
Para uso externo. Puede causar irritación a los ojos. Suspenda su empleo si se presentan signos de irritación o salpullido. No exponer lactantes y niños menores a radiación solar. Para niños menores de seis (6) meses consulte al médico. La exposición excesiva al sol es un peligro importante para la salud. Inflamable. No pulverizar cerca de llama. No perforar ni incinerar. No exponer al sol ni a temperaturas superiores a 50° C. Proteger los ojos durante la aplicación. Mantener fuera del alcance de los niños.
Aqua, Isohexadecane, Homosalate, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Octocrylene, Cetyl PEG/PPG-10/1 Dimethicone, Butyl Methoxydibenzoylmethane, Bis-ethylhexyloxyphenol Methoxyphenyl Triazine, PEG-8, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Caprylyl Glycol, Glucose, Sodium Chloride, Glycerin, Sodium Citrate, Disodium EDTA, Caprylic/Capric Triglycerides, Stearlkonium Hectorite, Propylene Carbonate, Lactoperoxidase, Glucose Oxidase, Aloe Barbadensis, Tocopheryl Acetate, Retinyl Palmitate, Tocopherol, Sodium Ascorbyl Phosphate
Agua, isohexadecano, homosalato, metoxicinamato de etilo, salicilato de etilo, octocrileno, cetil PEG/PPG-10/1 dimeticona, butil metoxidibenzoilmetano, bis-etilhexiloxifenol metoxifenil triazina, PEG-8, copolímero de MA/olefin C30-38/maleato de isopropilo, caprilil glicol, glucosa, cloruro de sodio, glicerina, citrato de sodio, ácido etilendiaminotetraacético disódico (EDTA), triglicerido caprilico / cáprico, hectorita de estearalconio, carbonato de propileno, lactoperoxidasa, glucose oxidasa, Aloe barbadensis, acetato de tocoferilo, palmitato de retinilo, tocoferol, ascorbil fosfato de sodio
HECHO EN E.U.A.
Importado y distribuido por: EVEREADY DE MÉXICO, S.A. de C.V. Jaime Balmes No. 11, Torre A, Piso 3, Col. Los Morales Polanco, C.P. 11510 México, D.F., R.F.C. EME-861014-J90. Tels. Atención al Consumidor: De Provincia al 01 800 7039900. En el D.F. al 91382057. SCHICK & ENERGIZER PERÚ, S.A. Av. Baquíjano y Carrillo (Ex-Jorge Chávez) N° 336, Miraflores. Lima 18 – Perú. Telif. 2429600. RUC: 20506285586. EVEREADY ECUADOR, C.A. Avda. Interoceánica Km. 4-1/2 (Vía Cumbaya-Miravalle) P.O. Box 17-17-1764, Quito-Ecuador, Telf. (593-2) 2899450. EVEREADY DE COLOMBIA, S.A. Transv. 18 No. 96 – 41 P i s o 8 B o g o t á - C o l omb i a . ENERGIZER ARGENTINA, S.A. Tucumán 540, Piso 22 "A" C.A.B.A. L e g a j o N o . 2 7 0 5 P r o d u c t o Cosmé t i co. Aprobado s e gún Resolución 155/98 Tel. At. al Cons. (011) 4742 - 8193.
©2010 Sun Pharmaceuticals, LLC
Manufactured by: Accra Pac, Inc (dba KIK Custom Products)
Ultra
MistTM
BANANA
BOATTM
Kids
Sin Lágrimas
Protector Solar con Fotoprotección
Avanzada UVA y UVB
FPS 60
AvoTriplexTM
Alta protección UVA
Probado en el sol
y laboratorio
Aplicación Rápida y Uniforme
Hipoalergénico
Resitente al agua
Sin Fragancia
Contenido neto 175 ml
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17630-2045-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f84b-f424-e053-dadaa90a57ce | Banana Boat Ultra Mist Kids FPS 60 LATAM |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17630-2045-1 | Banana Boat Ultra Mist Kids FPS 60 LATAM | 175 mL in 1 CAN | SPRAY | 175 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17630-2045 | BANANA BOAT ULTRA MIST KIDS FPS 60 LATAM (HOMOSALATE AND OCTINOXATE AND OCTISALATE AND OCTOCRYLENE AND OXYBENZONE AND AVOBENZONE) SPRAY [ACCRA-PAC, INC.] | 2 | Legacy NDC, 1 package rows | 20100423_3aa6550e-d1ed-4064-bf58-e694705669a8.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 2 | |
| HOMOSALATE | ACTIVE INGREDIENT | V06SV4M95S | 2 | |
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 2 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 2 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 2 | |
| HOMOSALATE | ACTIVE MOIETY | V06SV4M95S | 2 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 2 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 2 | |
| .ALPHA.-TOCOPHEROL ACETATE, D- | INACTIVE INGREDIENT | A7E6112E4N | 2 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 2 | |
| BEMOTRIZINOL | INACTIVE INGREDIENT | PWZ1720CBH | 2 | |
| CAPRYLYL GLYCOL | INACTIVE INGREDIENT | 00YIU5438U | 2 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 2 | |
| GLUCOSE OXIDASE | INACTIVE INGREDIENT | 0T8392U5N1 | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 2 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 2 | |
| PROPYLENE CARBONATE | INACTIVE INGREDIENT | 8D08K3S51E | 2 | |
| SODIUM ASCORBYL PHOSPHATE | INACTIVE INGREDIENT | 836SJG51DR | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 2 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 2 | |
| VITAMIN A PALMITATE | INACTIVE INGREDIENT | 1D1K0N0VVC | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 17630-2045 | 17630-2045-1 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LIQUID / NASAL | 2 mg/1ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / AURICULAR (OTIC) | 0.01 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL | 226 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SOLUTION / OPHTHALMIC | 0.9 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SYSTEM / TOPICAL | 3.1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / NASAL | 7.4 mg/1ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL | 1.35 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAMUSCULAR | 1486 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / OPHTHALMIC | 4 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRASYNOVIAL | 0.9 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / AURICULAR (OTIC) | 0.05 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRATUMOR | 1.2 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LIQUID / ORAL | 0.5 mg/1ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / OPHTHALMIC | 55 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / ORAL | 432 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR | 0.86 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACAUDAL | 210 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRA-ARTERIAL | 278 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / ORAL | 30 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAPERITONEAL | 0.54 %w/v | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, EXTENDED RELEASE / ORAL | 60 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / TOPICAL | 0.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION/ DROPS / OPHTHALMIC | 0.13 %w/v | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | TABLET / ORAL | 2 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | OINTMENT / TOPICAL | 1950 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, DELAYED RELEASE / ORAL | 97 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GRANULE, FOR SUSPENSION / ORAL | 162 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GEL / VAGINAL | 10 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / RETROBULBAR | 648 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / INTRA-ARTICULAR | 1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / RESPIRATORY (INHALATION) | 43 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | GEL / VAGINAL | 1250 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, EMULSION / INTRAVENOUS | 59 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, ORALLY DISINTEGRATING / ORAL | 3 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED / ORAL | 20 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / TOPICAL | 0.32 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / TOPICAL | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / SOFT TISSUE | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / RESPIRATORY (INHALATION) | 0.01 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO, SUSPENSION / TOPICAL | 1 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER / TOPICAL | NA | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | LOTION / TOPICAL | 5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | POWDER / SUBLINGUAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PARENTERAL | 584 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 289b4459-15ba-45f6-b571-51559b4b2d2e | 3aa6550e-d1ed-4064-bf58-e694705669a8 | 2010-04-24 | 289b4459-15ba-45f6-b571-51559b4b2d2e 3aa6550e-d1ed-4064-bf58-e694705669a8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.