Label: EVERYMAN JACK SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 58443-0364-3
- Packager: Prime Enterprises
- Category: HUMAN OTC DRUG LABEL
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 October 7, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
-
Directions
Apply liberally 15 minutes before sun exposure.
Reapply: After 80 minutes of swimming and 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 the risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10 a.m. to 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: ask a doctor.
-
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Cetyl Alcohol, Cetyl Phosphate, Ethylhexylglycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, PEG-100 Stearate, Phenoxyethanol, Phenyl Trimethicone, Polyethylene, Propylene Glycol, Silica, Sodium Hydroxide, Stearyl Alcohol, Tetrasodium Glutamate Diacetate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water
- Ohter Information
- Questions or Comments
- Every Man Jack Face Shield Sun Protection Lotion SPF 50
-
INGREDIENTS AND APPEARANCE
EVERYMAN JACK SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0364 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 49.9 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 29.94 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 49.9 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 99.8 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) ALOE VERA LEAF (UNII: ZY81Z83H0X) SHEA BUTTER (UNII: K49155WL9Y) CETYL ALCOHOL (UNII: 936JST6JCN) COCOA BUTTER (UNII: 512OYT1CRR) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETYL PHOSPHATE (UNII: VT07D6X67O) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) Product Characteristics Color white (off white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0364-3 95 mL in 1 TUBE; Type 0: Not a Combination Product 06/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/30/2020 Labeler - Prime Enterprises (101946028) Registrant - Prime Enterprises (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises 101946028 label(58443-0364) , manufacture(58443-0364) , analysis(58443-0364) , pack(58443-0364)
