TINTED MOISTURIZER SPF 20 BISQUE- octinoxate ,avobenzone cream

Tinted Moisturizer SPF 20 Bisque by

Drug Labeling and Warnings

Tinted Moisturizer SPF 20 Bisque by is a Otc medication manufactured, distributed, or labeled by Gurwitch Products, L.L.C., Beautymanuracuting Solutions Corperation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate (7.5%) , Avobenzone (2.0%)

WARNINGS

WARNINGS : FOR EXTERNAL USE ONLY.AVOID CONTACT WITH EYES. IF CONTACT OCCURS. RINSE THOROUGH WITH WATER.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

Direction for use : Apply to clean skin with fingertips. Layer for additional coverage.

 

INACTIVE INGREDIENT

Other Ingredients : Water ,Cetearyl Alcohol , PEG-40 Castor Oil ,Dimethicone , Polyglyceryl-4 Isostearate , Cyclomethicone , Potassium Cetyl Phosphate , Hexyl Laurate , Dromiceius Oil ,Tocopheryl Acetate ,Cetyl PEG/PPG-10/1 Dimethicone ,Polysorbate 60 ,Hydrogenated Polyisobutene , PEG-15 Cocamine , Phenoxyethanol ,Sodium Dehydroacetate ,Sodium Hyaluronate ,Allantoin ,Carbomer ,

 Aminomethyl Propanol ,  Methylparaben ,Magenesium Aluminu Silicate, Sodium Ascorbate , Isopropylparaben , Isobutylparaben , Butylpraben ,Propylparaben ,

(+/-) : CI 77891 ( Titanium Dioxide ) , CI 77492 ( Iron Oxide) , CI 77491 (Iron Oxide) , CI 77499 (Iron Oxide) , CI 77019 ( Mica )

PRINCIPAL DISPLAY PANEL

 

INGREDIENTS AND APPEARANCE

TINTED MOISTURIZER SPF 20 BISQUE  
octinoxate ,avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65342-1390
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	3 mL  in 40 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.8 mL  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dimethicone (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM ASCORBATE (UNII: S033EH8359)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ISOPROPYLPARABEN (UNII: A6EOX47QK0)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65342-1390-0	40 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/29/2010

Labeler - Gurwitch Products, L.L.C. (884875246)

Registrant - Beautymanuracuting Solutions Corperation (783200723)

Establishment
Name	Address	ID/FEI	Business Operations
Beautymanuracuting Solutions Corperation		783200723	manufacture