Label: RODAN AND FIELDS ESSENTIALS UVA/UVB- avobenzone, octinoxate, oxybenzone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated March 28, 2011

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    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

  • PRINCIPAL DISPLAY PANEL

    Essential UVA/UVB SPF 15

    1.7 fl.oz./50 ml

    image of front label

  • INGREDIENTS AND APPEARANCE
    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
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!