Label: PANAMA JACK BROAD SPECTRUM SPF 15 SPORT- avobenzone, octisalate, and octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0159-3 - 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
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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 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 Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylphthalimide, C12-15 Alkyl Benzoate, Cetyl Alcohol, Disodium EDTA, Fragrance (Parfum), Glycyrrhiza Glabra (Licorice) Root Extract, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Phenyl Trimethicone, Polyethylene, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Propylparaben, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Ubiquinone, Undecylcrylene Dimethicone, Water (Aqua)
- Other Information
- Questions or comments?
- Panama Jack Broad Spectrum SPF 15 Sunscreen
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INGREDIENTS AND APPEARANCE
PANAMA JACK BROAD SPECTRUM SPF 15 SPORT
avobenzone, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0159 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 19.6 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 49 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 18.13 mg in 1 mL Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) CETYL ALCOHOL (UNII: 936JST6JCN) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) LICORICE (UNII: 61ZBX54883) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E) UBIQUINONE Q2 (UNII: I7T5V2W47R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0159-3 89 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/11/2000 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/11/2000 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0159) , manufacture(58443-0159) , label(58443-0159) , analysis(58443-0159)
