R2 SYSTEM- avobenzone, homosalate, octinoxate, octocrylene lotion

R2 System by

Drug Labeling and Warnings

R2 System by is a Otc medication manufactured, distributed, or labeled by Water-Jel Technologies. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

QUESTIONS

800-275-3433  info@waterjel.com

www.waterjel.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

R2 SYSTEM 
avobenzone, homosalate, octinoxate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59898-130
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: 59898-130-26	1 in 1 CARTON	08/14/2010	08/01/2018
1		177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 59898-130-30	66 in 1 BOX, UNIT-DOSE	08/14/2010	08/01/2018
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(59898-130)