R2 SYSTEM- avobenzone, homosalate, octinoxate, octocrylene lotion 
Water-Jel Technologies

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.

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Radiaderm System

Active ingredients

Avobenzone 3.0%

Homosalate 7.5%

Octinoxate 5.0%

Octocrylene 2.7%

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 4 hours before medical treatment

Inactive ingredients

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

800-275-3433  info@waterjel.com

www.waterjel.com

Principal Display Panel

Image of PDP
R2 SYSTEM 
avobenzone, homosalate, octinoxate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-130
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-130-261 in 1 CARTON08/14/201008/01/2018
1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:59898-130-3066 in 1 BOX, UNIT-DOSE08/14/201008/01/2018
23 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/14/201008/01/2018
Labeler - Water-Jel Technologies (155522589)
Registrant - Water-Jel Technologies (155522589)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(59898-130)

Revised: 12/2020
Document Id: b6d5152f-f1d6-1913-e053-2995a90adb44
Set id: 76ce5c61-5b25-4d9b-9d2b-23cbf473759e
Version: 19
Effective Time: 20201219
 
Water-Jel Technologies