![PANAMA JACK BROAD SPECTRUM SPF 100 SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]](https://medic.hrt.org//dailymed/images/67f2d7ad-d646-44c6-e053-2991aa0a8bb9/58443-0257-3.jpg)
| NDC | 58443-0257-3 |
| Set ID | 67f2d7ad-d646-44c6-e053-2991aa0a8bb9 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Prime Enterprises Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Active Ingredients
- Purpose
- Uses
- Warnings
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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 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 ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylphthalimide, Cetyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Fragrance, Isopropylphthalimide, Phenoxyethanol, Phenyl Trimethicone, Polyethylene, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Ubiquinone, Undecylcrylene Dimethicone, Water
- Other information
- Questions or comments?
- 100 Broad Spectrum SPF 100 Panama Jack SPORT Sunscreen Lotion
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INGREDIENTS AND APPEARANCE
PANAMA JACK BROAD SPECTRUM SPF 100 SPORT SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0257 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 38.04 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 28.58 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 47.55 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 26.15 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 142.65 mg in 1 mL Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) UBIDECARENONE (UNII: EJ27X76M46) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) UNDECYLCRYLENE DIMETHICONE (10000 MW) (UNII: HA26P2LA4P) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0257-3 89 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/21/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/21/2018 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0257) , manufacture(58443-0257) , label(58443-0257) , analysis(58443-0257)
