RODAN AND FIELDS ESSENTIALS UVA/UVB - avobenzone, octinoxate, oxybenzone cream 
Cosmetic Enterprises Ltd.

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.

----------

Essentials UVA/UVB SPF 15

Active Ingredients                           Purpose

Avobenzone 2.0%                           Sunscreen

Octinoxate 7.5%                             Sunscreen

Oxybenzone 3.0 %                          Sunscreen

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 rash or irritation develops and lasts

Keep out of of children. If swallowed, get medical help or contact a Poison Control Center right away.

water (aqua purificata) purified, diisopropyl adipate, cyclopentasiloxane, methylpropanediol, lauryl methacrylate/glycol dimethacrylate crosspolymer, glyceryl stearate, peg-100 stearate, cetearyl alcohol, polyacrylamide, glyceryl dilaurate, ascorbyl palmitate, aluminum starch octenylsuccinate, ceteareth-20, laureth-7, sodium salicylate, c13-14 isoparaffin, fragrance (parfum), phenoxyethanol, methylparaben, propylparaben


Questions or Comments

1-888-895-5656


Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

image of back label.jpg

Essential UVA/UVB SPF 15

1.7 fl.oz./50 ml

image of front label

RODAN AND FIELDS  ESSENTIALS UVA/UVB
avobenzone, octinoxate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56152-0815
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.0 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
LAURETH-7 (UNII: Z95S6G8201)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56152-0815-21 in 1 BOX
1NDC:56152-0815-130 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2009
Labeler - Cosmetic Enterprises Ltd. (017701475)
Registrant - Rodan & Fields, LLC. (051659584)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprises Ltd017701475manufacture

Revised: 3/2011
Document Id: 272dbb65-38be-43ca-8b07-19e0786e89f4
Set id: c732ff03-8777-4431-989d-141ba2eca349
Version: 4
Effective Time: 20110328
 
Cosmetic Enterprises Ltd.