Label: EVERY MAN JACK SPF 30 SUNSCREEN- octisalate, avobenzone, homosalate, octocrylene lotion

  • 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 September 21, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active Ingredients

    Avobenzone 3%

    Octocrylene 5%

    Homosalate 7.5%

    Octisalate 5%

  • INACTIVE INGREDIENTS

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Carbomer, Ethylhexylglycerin, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Tetrasodium Glutamate Diacetate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water

  • Uses

    • helps prevent sunburn
      • if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

    Do not use on damaged or broken skin.

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Purpose

    Sunscreen

  • 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 value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10am-2pm
    • wear long sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Other Information

    • protect this product from excesive heat and direct sun
  • Questions or Comments?

    877-875-5225, 9-5 PST weekdays.

  • Every Man Jack SPF 30 Fragrance Free Sun Protection Lotion

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    EVERY MAN JACK  SPF 30 SUNSCREEN
    octisalate, avobenzone, homosalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0360
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE75.75 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50.5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.3 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    Product Characteristics
    Colorwhite (Off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0360-4200 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/04/2020
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0360) , manufacture(58443-0360) , label(58443-0360) , analysis(58443-0360)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!