![PANAMA JACK SPF 85 SPORT DRY TOUCH SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES INC.]](https://medic.hrt.org//dailymed/images/2913eb8a-3cb0-21d4-e054-00144ff88e88/58443-0221-3.jpg)
| NDC | 58443-0221-3 |
| Set ID | 2913eb8a-3cb0-21d4-e054-00144ff88e88 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Prime Enterprises Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Active Ingredients
- Purpose
- Uses
- WARNINGS
-
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
-
INACTIVE INGREDIENT
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylphthalimide, Cetyl Alcohol, Disodium EDTA, Fragrance, 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
- Other Information
- Questions or Comments?
- Panama Jack Sport SPF 85 Dry Touch Sunscreen
-
INGREDIENTS AND APPEARANCE
PANAMA JACK SPF 85 SPORT DRY TOUCH SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0221 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 38.8 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29.1 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 121.25 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 48.5 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 26.68 mg in 1 mL Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LICORICE (UNII: 61ZBX54883) EDETATE DISODIUM (UNII: 7FLD91C86K) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) UBIQUINONE Q2 (UNII: I7T5V2W47R) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E) METHYLPARABEN (UNII: A2I8C7HI9T) (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0221-3 89 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/30/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/30/2011 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0221) , manufacture(58443-0221) , label(58443-0221) , analysis(58443-0221)
