COVER YOUR MOUTH SPF 8 LIP PROTECTOR- titanium dioxide lipstick

COVER YOUR MOUTH by

Drug Labeling and Warnings

COVER YOUR MOUTH by is a Otc medication manufactured, distributed, or labeled by ORIGINS NATURAL RESOURCES INC., ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER N.V., Len-Ron Manufacturing Division of Aramis Inc., Aramis Inc., Northtec Bristol, Northtec Keystone, Estee Lauder Pennsylvania Distribution Center 2, Estee Lauder Cosmetics, Ltd., Estee Lauder Cosmetics, Ltd, Estee Lauder Cosmetics Distribution Center, Estee Lauder Kabushiki Kaisha, Whitman Laboratories Ltd., Aveda Corporation, PRIVALE LABEL SELECT LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

active ingredient: titanium dioxide 1.80%

INACTIVE INGREDIENT

inactive ingredients: canola oil [] beeswax (cera alba) [] lecithin [] mentha piperita (peppermint) essential oil (olea) [] cocos nucifera (coconut) oil [] vanilla planifolia [] aloe barbadensis (aloe) leaf juice [] lauroyl lysine [] tocopherol (vitamin e) [] aluminum stearate [] stearic acid

WARNINGS

warning: stop use if signs of irritation appear and check with doctor.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL


ORIGINS

COVER YOUR MOUTH

LIP PROTECTOR

WITH SPF 8

NT WT 0.15 OZ./ 4.5 G



origins natural resources inc.
new york, ny 10022

INGREDIENTS AND APPEARANCE

COVER YOUR MOUTH  SPF 8 LIP PROTECTOR
titanium dioxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59427-575
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CANOLA OIL (UNII: 331KBJ17RK)
WHITE WAX (UNII: 7G1J5DA97F)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PEPPERMINT OIL (UNII: AV092KU4JH)
COCONUT OIL (UNII: Q9L0O73W7L)
VANILLA (UNII: Q74T35078H)
LAUROYL LYSINE (UNII: 113171Q70B)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59427-575-01	4.5 g in 1 CASE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/1999

Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		205952385	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Len-Ron Manufacturing Division of Aramis Inc.		809771152	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Aramis Inc.		042918826	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Bristol		949264774	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Keystone		618107429	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2		828534516	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd.		255175580	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd		253616536	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Distribution Center		208579636	repack, relabel

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Kabushiki Kaisha		712808195	relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Whitman Laboratories Ltd.		216866277	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
PRIVALE LABEL SELECT LTD		005415463	manufacture