Label: PANAMA JACK BROAD SPECTRUM SPF 100 SPORT SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0257-3 - Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 17, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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)
