CALM DYNAMICS GENTLE HYDRATING DAY SPF 15

Dosage form: cream
Ingredients: OCTINOXATE 7g in 100mL, OCTISALATE 4g in 100mL, OXYBENZONE 2g in 100mL
Labeler: JAFRA COSMETICS INTERNATIONAL
NDC Code: 68828-155

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.

CALM DYNAMICS GENTLE HYDRATING DAY CREAM SPF 15

SUNSCREEN ACTIVE INGREDIENT (SPF 15):
OCTINOXATE/ETHYLHEXYL METHOXYCINNAMATE, OCTISALATE/ETHYLHEXYL SALICYLATE, OXYBENZONE/BENZOPHENONE-3

PURPOSE: SUNSCREEN

OTHER INGREDIENTS: WATER/AQUA, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, SQUALANE, POLYSORBATE 60, TRIDECYL NEOPENTANOATE, ALUMINUM STARCH OCTENYLSUCCINATE, SACCHARIDE ISOMERATE, BUTYLENE GLYCOL, AVENA SATIVA (OAT) KERNEL EXTRACT, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LURETH-7, HEMIDESMUS INDICUS EXTRACT, PHYLLANTHUS EMBLICA EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) EXTRACT, DMDM HYDANTOIN, BIOSACCHARIDE GUM-4, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, PANTHENOL, TOCOPHERYL ACETATE, DIMETHICONE, PUERARIA LOBATA ROOT EXTRACT, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, TRISODIUM EDTA, PENTYLENE GLYCOL, PROPAMIDOBENZOIC ACID.

GENTLE HYDRATING DAY CREAM SPF 15

TO USE: IN THE MORNING AFTER CLEANSING, SMOOTH OVER FACE AND THROAT.

DISCONTINUE USE IF IRRITATION OCCURS.

KEEP OUT OF REACH OF CHILDREN.

JAFRA

CALMING DYNAMICS

GENTLE HYDRATING DAY CREAM SPF 15



  


CALM DYNAMICS GENTLE HYDRATING DAY  SPF 15
octinoxate octisalate oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-155
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE4 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) 
SQUALANE 
POLYSORBATE 60 
TRIDECYL NEOPENTANOATE 
ALUMINUM STARCH OCTENYLSUCCINATE 
SACCHARIDE ISOMERATE 
OAT 
POLYACRYLAMIDE (10000 MW) 
C13-14 ISOPARAFFIN 
LAURETH-7 
HEMIDESMUS INDICUS ROOT 
BIOSACCHARIDE GUM-1 
PHYLLANTHUS EMBLICA FRUIT 
GLYCYRRHIZA GLABRA 
IODOPROPYNYL BUTYLCARBAMATE 
DMDM HYDANTOIN 
PUERARIA MONTANA VAR. LOBATA ROOT 
CHONDRUS CRISPUS 
PANTHENOL 
.ALPHA.-TOCOPHEROL ACETATE 
PENTYLENE GLYCOL 
HYDROXYPHENYL PROPAMIDOBENZOIC ACID 
PEG-4 LAURATE 
Packaging
#Item CodePackage Description
1NDC:68828-155-121 JAR (JAR) in 1 BOX
1NDC:68828-155-6250 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/24/2012
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
NameAddressID/FEIOperations
Jafra Manufacturing, S.A. de C.V.814732061manufacture

Revised: 05/2012
 
JAFRA COSMETICS INTERNATIONAL

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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