DESPIGMEN PROTECTIVE 25- octinoxate, titanium dioxide cream

DESPIGMEN PROTECTIVE 25 by

Drug Labeling and Warnings

DESPIGMEN PROTECTIVE 25 by is a Otc medication manufactured, distributed, or labeled by LABORATORIOS DE COSMETICA SCIENTIFICA AT, LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Protector that provides the latest in scientific cosmetics to prevent dark spots, protecting the skin from sun damage and aging.

Protection against UVA light is due to its state-of-the art "organo-mineral" solar filter.

Protection against UVB light occurs by a highly efficient inorganic filter.

Perfectly protected, the skin appear uniform, luminous, and free from shine.

INSTRUCTIONS FOR USE

Directions:  Gently massage into the skin of the face, neck, decolletage, and hands 30 minutes before sun exposure.

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 6% - sunscreen

TITANIUM DIOXIDE 1.75% - sunscreen

INACTIVE INGREDIENT

OTHER INGREDIENTS:  AQUA, TRIBEHENIN PEG-20 ESTERS, OCTYLDODECYL MYRISTATE, HYDROGENATED POLYDECENE, SIMMONDSIA CHINENSIS OIL, METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL, GLYCERIN, C12-15 ALKYLBENZOATE, CETEARYL ALCOHOL, DECYL GLUCOSIDE, TOPHENYL ACETATE, ALUMINUM STEARATE, POLYHYDROXYSTEARIC ACID, ALUMINIUM OXIDE, DISODIUM EDTA, PROPYLENE GLYCOL, XANTYAN GUM, PHENOXYETHANOL, METHYLPARABEN, BUTYLPARABEN, ETHYLPARABEN, PROPYLPARABEN.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DESPIGMEN PROTECTIVE 25 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75870-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 mL  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	0.88 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)
ABETIMUS SODIUM (UNII: F5Y7739G6U)
JOJOBA OIL (UNII: 724GKU717M)
BISOCTRIZOLE (UNII: 8NT850T0YS)
GLYCERIN (UNII: PDC6A3C0OX)
DODECYL BENZOATE (UNII: N4F51K239A)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)
ALUMINUM OXIDE (UNII: LMI26O6933)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75870-003-02	1 in 1 CARTON
1	NDC: 75870-003-01	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 AT (467582193)

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