![PANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC (OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE) LOTION [PRIME ENTERPRISES, INC.]](https://medic.hrt.org//dailymed/images/82c56c45-1f18-418d-946b-d320b9369258/58443-0179-3.jpg)
| NDC | 58443-0179-3 |
| Set ID | 82c56c45-1f18-418d-946b-d320b9369258 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Prime Enterprises, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Purpose
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Warnings • For external use only • Do not use on damaged or broken skin • When using this productkeep out of eyes. Rinse with water to remove. • Stop use and ask a doctorif rash occurs. • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
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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 in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: •limit time in the sun, especially from 10 a.m. - 2 p.m. •wear long-sleeve shirts, pants, hats, and sunglasses •children under 6 months: Ask a doctor.
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Inactive Ingrediets
Aluminium Starch Octenylsuccinate, Bis-PEG-12 Dimethicone Beeswax, Cetyl PEG/PPG-10/1 Dimethicone, Decyl Glucoside, Diazolidinyl Urea, Diisodecyl Adipate, Disodium EDTA, Glycerin, Hexyl Laurate, Hydrogenated Castor Oil, Methylparaben, Mineral Oil, Polyethylene, Polyglyceryl-4 Isostearate, Propylene Glycol, Propylparaben, Silica, Sodium Chloride, Tocopheryl Acetate, Triethoxycaprylysilane, Water
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL - 30mL Bottle Label
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INGREDIENTS AND APPEARANCE
PANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC
octinoxate, octisalate, octocrylene, and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0179 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 49.35 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 49.35 in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 19.74 in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 29.61 mg in 1 mL Inactive Ingredients Ingredient Name Strength HEXYL LAURATE (UNII: 4CG9F9W01Q) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) BIS-PEG-10 DIMETHICONE/DIMER DILINOLEATE COPOLYMER (UNII: CF5W1YCX11) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) DIISODECYL ADIPATE (UNII: 3V0Q382O0P) GLYCERIN (UNII: PDC6A3C0OX) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) MINERAL OIL (UNII: T5L8T28FGP) EDETATE DISODIUM (UNII: 7FLD91C86K) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0179-3 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/29/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/29/2011 Labeler - Prime Enterprises, Inc. (101946028) Registrant - Prime Enterprises, Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 label(58443-0179) , pack(58443-0179) , manufacture(58443-0179) , analysis(58443-0179)
