Label: PANAMA JACK BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 58443-0328-3
- 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 May 12, 2020
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- 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, Cetyl Alcohol, Cetyl Phosphate, Disodium EDTA, Ethylhexylglycerin, Fragrance, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, PEG-100 Stearate, Phenoxyethanol, Phenyl Trimethicone, Polyethylene, Propylene Glycol, Silica, Sodium Hydroxide, Stearyl Alcohol, Tocopheryl Acetate, Ubiquinone, Water
- Other information
- Questions or comments?
- Panama Jack Sport Broad Spectrum SPF 50 Sunscreen Lotion
-
INGREDIENTS AND APPEARANCE
PANAMA JACK BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0328 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29.73 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 49.55 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 49.55 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 99.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) CETYL PHOSPHATE (UNII: VT07D6X67O) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CETYL ALCOHOL (UNII: 936JST6JCN) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) UBIDECARENONE (UNII: EJ27X76M46) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETATE DISODIUM (UNII: 7FLD91C86K) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0328-3 89 mL in 1 TUBE; Type 0: Not a Combination Product 03/28/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/28/2019 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0328) , manufacture(58443-0328) , label(58443-0328) , analysis(58443-0328)
