MAYBELLINE NEW YORK BABY LIPS MOISTURIZING LIP BALM SPF 20- octinoxate octisalate lipstick

Maybelline New York by

Drug Labeling and Warnings

Maybelline New York by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 7.5%

Octisalate 3%

Uses

HELPS PREVENT SUNBURN.

HIGHER SPF GIVES MORE SUNBURN PROTECTION

Directions

APPLY BEFORE SUN EXPOSURE.

Warnings

STOP USE AND ASK A DOCTOR IF SKIN RASH OR IRRITATION DEVELOPS AND LASTS.

Inactive ingredients

polybutene, octyldodecanol, isopropyl myristate, petrolatum, polyethylene, ozokerite, butyrospermum park II (shea) butter, diisostearyl malate, euphorbia cerifera (candelilla) wax, vp/hexadecene copolymer, silica dimethyl silylate, fragrance, calcium aluminum borosilicate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, tocopherol, tocopheryl acetate, alumina, flavor, silica, isopropyl palmitate, pentaerythrityl tetraisostearate, limonene, synthetic fluorphlogopite, calcium sodium borosilicate, benzyl benzoate, centella asiatica extract, aluminum hydroxide, citral, linalool, hexyl cinnamal, tin oxide, geraniol, eugenol, aloe barbadensis leaf extract, calcium pantothenate, honey, ascorbic acid, dimethicone, sodium chondroitin sulfate, atelocollagen; may contain: titanium dioxide, mica, red 28 lake, iron oxides, red 7, red 22 lake, yellow 5 lake, blue 1 lake, yellow 6 lake, carmine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAYBELLINE NEW YORK  BABY LIPS MOISTURIZING LIP BALM SPF 20
octinoxate octisalate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-452
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.33 g  in 4.4 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.132 g  in 4.4 g

Inactive Ingredients
Ingredient Name	Strength
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-452-01	1 in 1 BLISTER PACK	08/01/2011
1		4.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2011

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products Inc		624244349	manufacture(49967-452)