TINTED MOISTURIZER SPF-20 GOLDEN RADIANCE- octinoxate ,avobenzone cream

Tinted Moisturizer SPF-20 Golden Radiance by

Drug Labeling and Warnings

Tinted Moisturizer SPF-20 Golden Radiance 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 , Dimethicone , Mica ,Cetearyl Alcohol , Hydrogenated Polyisobutene ,  Xyitilglucoside , PEG-40 Castor Oil ,Polyglyceryl-4 Isostearate , Cyclopentaxiloxane , Potassium Cetyl Phosphate , Hexyl Laurate ,Anhydroxylitol,Sodium Hyaluronate ,Tocopheryl Acetate ,Sodium Ascorbate , Camellia Sinensis Leaf Extract , Hydrogenated Olive Oil ,Butyrospermum Parkii(Shea  Butter) , Xyritol , Copper Gluconate , Allantoin , Dipotassium Glycyrrhizate , Cetyl PEG/PPG-10/1 Dimethicone ,Polysorbate 60 , Phenoxyethanol ,Butylene Glycol ,Tribehenin ,Sodium Dehydroacetate ,Carbomer , Aminomethyl Propanol ,  Tetrasodium EDTA , Magenesium Aluminu Silicate,(+/-) :Titanium Dioxide  , Iron Oxide, Tin Oxide

PRINCIPAL DISPLAY PANEL

 

INGREDIENTS AND APPEARANCE

TINTED MOISTURIZER SPF-20 GOLDEN RADIANCE 
octinoxate ,avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65342-1393
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65342-1393-0	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