Tinted Moisturizer SPF-20 Caramel

Dosage form: cream
Ingredients: Octinoxate 3mL in 40mL, Avobenzone 0.8mL in 40mL
Labeler: Gurwitch Products, L.L.C.
NDC Code: 65342-1391

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.

Octinoxate (7.5%) , Avobenzone (2.0%)


WARNINGS : FOR EXTERNAL USE ONLY.AVOID CONTACT WITH EYES. IF CONTACT OCCURS. RINSE THOROUGH WITH WATER.

Keep out of reach of children.

Direction for use : Apply to clean skin with fingertips. Layer for additional coverage.

 

Other Ingredients : Water ,Cetearyl Alcohol , PEG-40 Castor Oil ,Dimethicone , Polyglyceryl-4 Isostearate , Cyclomethicone , Potassium Cetyl Phosphate , Hexyl Laurate , Dromiceius Oil ,Tocopheryl Acetate ,Cetyl PEG/PPG-10/1 Dimethicone ,Polysorbate 60 ,Hydrogenated Polyisobutene , PEG-15 Cocamine , Phenoxyethanol ,Sodium Dehydroacetate ,Sodium Hyaluronate ,Allantoin ,Carbomer ,

 Aminomethyl Propanol ,  Methylparaben ,Magenesium Aluminu Silicate, Sodium Ascorbate , Isopropylparaben , Isobutylparaben , Butylpraben ,Propylparaben ,

(+/-) : CI 77891 ( Titanium Dioxide ) , CI 77492 ( Iron Oxide) , CI 77491 (Iron Oxide) , CI 77499 (Iron Oxide) , CI 77019 ( Mica )



 

TINTED MOISTURIZER SPF-20 CARAMEL 
octinoxate ,avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65342-1391
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate3 mL  in 40 mL
Avobenzone (Avobenzone) Avobenzone0.8 mL  in 40 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Dimethicone 
CYCLOMETHICONE 5  
POLYGLYCERYL-4 ISOSTEARATE 
CETOSTEARYL ALCOHOL 
HEXYL LAURATE 
.ALPHA.-TOCOPHEROL ACETATE, D- 
SODIUM DEHYDROACETATE 
HYALURONATE SODIUM 
ALLANTOIN 
SODIUM ASCORBATE 
POLYSORBATE 60 
PHENOXYETHANOL 
METHYLPARABEN 
PROPYLPARABEN 
BUTYLPARABEN 
ISOPROPYLPARABEN 
ISOBUTYLPARABEN 
AMINOMETHYLPROPANOL 
LINALOOL, (+/-)-  
Packaging
#Item CodePackage Description
1NDC:65342-1391-040 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/29/2010
Labeler - Gurwitch Products, L.L.C. (884875246)
Registrant - Beautymanuracuting Solutions Corperation (783200723)
Establishment
NameAddressID/FEIOperations
Beautymanuracuting Solutions Corperation783200723manufacture

Revised: 05/2011
 
Gurwitch Products, L.L.C.

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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