TINTED MOISTURIZER- octinoxate, octisalate and titanium dioxide cream

Tinted Moisturizer by

Drug Labeling and Warnings

Tinted Moisturizer by is a Otc medication manufactured, distributed, or labeled by Femme Couture International, Inc, Nuworld Corporation, Nu-World Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate 6%
Octisalate 4%
Titanium Dioxide 3%

PURPOSE

Sunscreen

WARNINGS

For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs
Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

a21b2c1b-2116-4fd6-b254-29f4bf1ec23f

INGREDIENTS AND APPEARANCE

TINTED MOISTURIZER   SPF-15
octinoxate, octisalate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76351-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	3.06 g  in 51.03 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	2.04 g  in 51.03 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	1.53 g  in 51.03 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Carbomer 934 (UNII: Z135WT9208)
EDETATE TRISODIUM (UNII: 420IP921MB)
Glycerin (UNII: PDC6A3C0OX)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Dimethicone (UNII: 92RU3N3Y1O)
Dimethicone (UNII: 92RU3N3Y1O)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sorbic Acid (UNII: X045WJ989B)
Caprylyl Glycol (UNII: 00YIU5438U)
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)
Dimethicone (UNII: 92RU3N3Y1O)
HYDROGENATED POLYBUTENE (370 MW) (UNII: V5H8103878)
Hexyl Laurate (UNII: 4CG9F9W01Q)
SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2)
Squalane (UNII: GW89575KF9)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
Trolamine (UNII: 9O3K93S3TK)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
Mica (UNII: V8A1AW0880)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Ferric Oxide Red (UNII: 1K09F3G675)
Ferrosoferric Oxide (UNII: XM0M87F357)
Brown Iron Oxide (UNII: 1N032N7MFO)
Titanium Dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76351-100-01	51.03 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/26/2011

Labeler - Femme Couture International, Inc (010053513)

Establishment
Name	Address	ID/FEI	Business Operations
Nuworld Corporation		628045858	manufacture, pack, label

Establishment
Name	Address	ID/FEI	Business Operations
Nu-World Corporation		968288055	label, pack