![R2 SYSTEM (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE) LOTION [WATER-JEL TECHNOLOGIES]](https://medic.hrt.org//dailymed/images/76ce5c61-5b25-4d9b-9d2b-23cbf473759e/MM1.jpg)
| NDC | 59898-130-26, 59898-130-30 |
| Set ID | 76ce5c61-5b25-4d9b-9d2b-23cbf473759e |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Water-Jel Technologies |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Active ingredients
- PURPOSE
- Uses
- helps prevent sunburn
- higher SPF gives more sunburn protection
- moderate protection against sunburn
- Warnings
For external use only
CloseKeep 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
- 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
Close - QUESTIONS
- Principal Display Panel
- INGREDIENTS AND APPEARANCE
R2 SYSTEM
avobenzone, homosalate, octinoxate, octocrylene lotionProduct 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) CloseEstablishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(59898-130)
