SOFT DERM INTENSIVE DEFENSE 8 SPF- octinoxate, titanium dioxide cream

SOFT DERM INTENSIVE DEFENSE 8 SPF by

Drug Labeling and Warnings

SOFT DERM INTENSIVE DEFENSE 8 SPF by is a Otc medication manufactured, distributed, or labeled by LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

CALMING FACIAL EMULSION DAY

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

INSTRUCTIONS FOR USE

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

WARNINGS

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 INGREDIENT

ACTIVE INGREDIENTS:

OCTINOXATE 20% - sunscreen

TITANIUM DIOXIDE 14% - sunscreen

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOFT DERM INTENSIVE DEFENSE 8 SPF 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75870-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	10 mL  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	7.045 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75870-002-02	1 in 1 CARTON
1	NDC: 75870-002-01	50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2007

Labeler - LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA (467582193)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA		467582193	manufacture