SOFT DERM INTENSIVE DEFENSE 8 SPF

Dosage form: cream
Ingredients: OCTINOXATE 10mL in 50mL, TITANIUM DIOXIDE 7.045mL in 50mL
Labeler: LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA
NDC Code: 75870-002

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.

SOFT DERM INTENSIVE DEFENSE 8 SPF

CALMING FACIAL EMULSION DAY

Balanced facial emulsion.  Specifically created for the care of sensitive skin, with effects that are relaxing, cleaning, restoring, and protective.

Directions:  After cleansing and toning the skin, gently massage into the skin until fully absorbed.


Warnings:  For external use only.  Keep out of reach of children.  Avoid contact with eyes.  Discontinue use if signs of irritation or rash appear.


ACTIVE INGREDIENTS:

OCTINOXATE 20% - sunscreen

TITANIUM DIOXIDE 14% - sunscreen

OTHER INGREDIENTS:  AQUA (THERMAL WATER), ICTYLDODECYL MYRISTATE, PEG-6 STEARATE, GLYCERIN, C12-15 ALKYL BENZOATE, CETYL ALCOHOL, DIMETHICONE, ALOE BARBADENSIS GEL 10:1, CAPPARIS SPINOSA FRUIT EXTRACT, HYDROLYZED ENTEROMORPHA COMPRESSA EXTRACT, CETETH-20, GLYCERYL STEARATE, STEARETH-20, XANTUAN GUM, ALLANTOIN, BUTYLENE GLYCOL, ALUMINUM STEARATE, POLYHYDROXYSTEARIC ACID, ALUMINUM OXIDE, DISODIUM EDTA, PHENOXYETANOL, METHYLPARABEN, BUTYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN, DIMENTICONE CROSSPOLYMER, BHT, PERFUM.



SOFT DERM INTENSIVE DEFENSE 8 SPF 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75870-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE10 mL  in 50 mL
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE7.045 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
OCTYLDODECYL MYRISTATE 
PEG-6 STEARATE 
GLYCERIN 
ALKYL (C12-15) BENZOATE 
CETYL ALCOHOL 
DIMETHICONE 
ALOE VERA LEAF 
CAPER BERRY 
CAPSOSIPHON FULVESCENS 
CETETH-20 
GLYCERYL MONOSTEARATE 
STEARETH-20 
XANTHAN GUM 
ALLANTOIN 
BUTYLENE GLYCOL 
ALUMINUM STEARATE 
HYDROXYSTEARIC ACID 
ALUMINUM OXIDE 
EDETATE DISODIUM 
PHENOXYETHANOL 
METHYLPARABEN 
BUTYLPARABEN 
ETHYLPARABEN 
PROPYLPARABEN 
ISOBUTYLPARABEN 
BUTYLATED HYDROXYTOLUENE 
WATER 
ULVA COMPRESSA PROTEIN (ACID HYDROLYZED, 300-5000 MW) 
Packaging
#Item CodePackage Description
1NDC:75870-002-021 TUBE (TUBE) in 1 CARTON
1NDC:75870-002-0150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/2007
Labeler - LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA (467582193)
Establishment
NameAddressID/FEIOperations
LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA467582193manufacture

Revised: 06/2011
 
LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA

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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