R2

Dosage form: lotion
Ingredients: Avobenzone 3g in 100mL, Homosalate 7.5g in 100mL, Octinoxate 5g in 100mL, Octocrylene 2.7g in 100mL
Labeler: Water-Jel Technologies
NDC Code: 59898-120

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.

R2

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 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

800-275-3433  info@waterjel.com

www.waterjel.com

Principal Display Panel

R2 
avobenzone, homosalate, octinoxate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-120
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone3 g  in 100 mL
Homosalate (Homosalate) Homosalate7.5 g  in 100 mL
Octinoxate (Octinoxate) Octinoxate5 g  in 100 mL
Octocrylene (Octocrylene) Octocrylene2.7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE 
GLYCERYL STEARATE CITRATE 
EDETATE DISODIUM 
POLYOXYL 20 CETOSTEARYL ETHER 
C12-15 ALKYL BENZOATE 
PHENOXYETHANOL 
ETHYLHEXYLGLYCERIN 
CASEIN 
CETOSTEARYL ALCOHOL 
CAPRYL METHICONE 
SILICON DIOXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:59898-120-261 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
1177 mL in 1 BOTTLE, PLASTIC
2NDC:59898-120-3066 PACKET (PACKET) in 1 BOTTLE, UNIT-DOSE
23 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/14/2010
Labeler - Water-Jel Technologies (155522589)
Registrant - Water-Jel Technologies (155522589)
Establishment
NameAddressID/FEIOperations
Water-Jel Technologies155522589manufacture

Revised: 02/2011
 
Water-Jel Technologies

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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