SOFT DERM INTENSIVE DEFENSE 8 SPF - octinoxate, titanium dioxide cream 
LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA

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.

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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.


Image of Carton


SOFT DERM INTENSIVE DEFENSE 8 SPF 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75870-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE10 mL  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE7.045 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)  
PEG-6 STEARATE (UNII: 8LQC57C6B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAPER BERRY (UNII: 7G4C45EE8C)  
CAPSOSIPHON FULVESCENS (UNII: C59NK6GFJH)  
CETETH-20 (UNII: I835H2IHHX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
STEARETH-20 (UNII: L0Q8IK9E08)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALLANTOIN (UNII: 344S277G0Z)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
WATER (UNII: 059QF0KO0R)  
ULVA COMPRESSA PROTEIN (ACID HYDROLYZED, 300-5000 MW) (UNII: Q04O53779D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75870-002-021 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/FEIBusiness Operations
LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA467582193manufacture

Revised: 6/2011
Document Id: debf540c-ac04-4732-8ea1-9b1f1c2793e4
Set id: a4b9580d-f44d-4fa6-ac59-95da3965326f
Version: 4
Effective Time: 20110615
 
LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA