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Rodan and Fields Essentials UVA/UVB

Dosage form: cream
Ingredients: AVOBENZONE 2.0mL in 100mL, OCTINOXATE 7.5mL in 100mL, OXYBENZONE 3.0mL in 100mL
Labeler: Cosmetic Enterprises Ltd.
NDC Code: 56152-0815

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.

Essential UVA/UVB SPF 15

1.7 fl.oz./50 ml

RODAN AND FIELDS  ESSENTIALS UVA/UVB
avobenzone, octinoxate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56152-0815
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE2.0 mL  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE3.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL ADIPATE 
CYCLOMETHICONE 5 
METHYLPROPANEDIOL 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
CETOSTEARYL ALCOHOL 
ASCORBYL PALMITATE 
ALUMINUM STARCH OCTENYLSUCCINATE 
POLYOXYL 20 CETOSTEARYL ETHER 
LAURETH-7 
SODIUM SALICYLATE 
C13-14 ISOPARAFFIN 
PHENOXYETHANOL 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:56152-0815-21 JAR (JAR) 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/FEIOperations
Cosmetic Enterprises Ltd017701475manufacture

Revised: 03/2011
 
Cosmetic Enterprises Ltd.

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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