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R2 (Water-Jel Technologies)

Available Formats

Dosage Form Package Information Links
LOTION 1 BOTTLE, PLASTIC in 1 CARTON (59898-120-26) > 177 mL in 1 BOTTLE, PLASTIC Label Information
LOTION 66 PACKET in 1 BOTTLE, UNIT-DOSE (59898-120-30) > 3 mL in 1 PACKET Label Information

Complete R2 Information

  • Active ingredients

    Avobenzone 3.0%

    Homosalate 7.5%

    Octinoxate 5.0%

    Octocrylene 2.7%


  • PURPOSE

    Sunscreen

    Sunscreen

    Sunscreen

    Sunscreen


  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • moderate protection against sunburn

  • Warnings

    For external use only

    When using this product
    • keep out of eyes
    • rinse with water to remove

    Stop use and ask a doctor if
    • skin rash or irritation develops and lasts

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.


  • Directions

    • apply to skin a minimum of 3 times a day and at bedtime
    • apply generously and evenly before sun exposure
    • reapply after towel drying, swimming or sweating
    • children under 6 months of age: consult a doctor

  • Other information

    • ensure skin is free of lotion immediately before medical treatment

  • Inactive ingredients

    Enter section text here purified water, C12-15 alkyl benzoate, milk protein, caprylyl methicone, ethylhexyl methoxycrylene, ceteareth 20, cetearyl alcohol, silica, ammonium acryloyldimethyltaurate VP copolymer, glyceryl monostearate, glyceryl stearate citrate, phenoxyethanol, edetate disodium, ethylhexylglycerin, glyceryl stearate


  • QUESTIONS

    800-275-3433  info@waterjel.com

    www.waterjel.com


  • Principal Display Panel

    Image of PDP

  • INGREDIENTS AND APPEARANCE
    R2 
    avobenzone, homosalate, octinoxate, octocrylene lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59898-120
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7.5 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.7 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CASEIN (UNII: 48268V50D5)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MYRISTYL TRISILOXANE (UNII: J7960S4R1T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59898-120-26 1 in 1 CARTON 08/14/2010
    1 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:59898-120-30 66 in 1 BOTTLE, UNIT-DOSE 08/14/2010
    2 3 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 08/14/2010
    Labeler - Water-Jel Technologies (155522589)
    Registrant - Water-Jel Technologies (155522589)
    Establishment
    Name Address ID/FEI Business Operations
    Water-Jel Technologies 155522589 manufacture(59898-120)