MINERAL TINTED MOISTURIZER- titanium dioxide lotion

MINERAL TINTED MOISTURIZER by

Drug Labeling and Warnings

MINERAL TINTED MOISTURIZER by is a Otc medication manufactured, distributed, or labeled by Aveda Corporation, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER N.V., Len-Ron Manufacturing Division of Aramis Inc., Aramis Inc., Northtec Bristol, Northtec Keystone, PADC 1, 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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

MINERAL TINTED MOISTURIZER SPF 15
OIL FREE LOTION

1.7 FL . OZ/ 50 ML

AVEDA CORPORATION DISTR.
MINNEAPOLIS, MN  54499 7106

ACTIVE INGREDIENT: TITANIUM DIOXIDE, 4.3%

TO USE: APPLY LIBERALLY AS OFTEN AS POSSIBLE BEFORE SUN EXPOSURE

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. IF IRRITATION PERSISTS CONSULT A HEALTH CARE PRACTITIONER. KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL TINTED MOISTURIZER   SPF 15
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57677-057
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.30 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57677-057-01	1 in 1 CARTON
1	NDC: 57677-057-02	50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2003

Labeler - Aveda Corporation (071352058)

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
PADC 1		110482184	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	manufacture, label, 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