ALMOST POWDER MAKEUP SPF 15- titanium dioxide, octinoxate powder

ALMOST POWDER MAKEUP by

Drug Labeling and Warnings

ALMOST POWDER MAKEUP by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES 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, ASANUMA CORP LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

active ingredients: titanium dioxide 13.00% [] octinoxate 2.00%

INACTIVE INGREDIENT

inactive ingredients: talc [] dimethicone [] nylon-12 [] silica [] squalane [] boron nitride [] vinyl dimethicone/methicone silsesquioxane crosspolymer [] cetyl caprylate [] diisostearyl malate [] phytosteryl/isostearyl/cetyl/stearyl/behenyl  dimer dilinoleate [] methicone [] aluminum hydroxide [] glycerin [] sodium hyaluronate [] magnesium palmitoyl glutamate [] sodium palmitoyl sarcosinate [] palmitoyl proline [] alumina [] tocopherol [] palmitic acid [] 1,2-hexanediol [] ascorbyl tetraisopalmitate [] tin oxide [] sodium dehydroacetate []  [+/- iron oxides (ci 77499, ci 77492, ci 77491) [] mica [] titanium dioxide (ci 77891)]

WARNINGS

warning: keep out of eyes. stop use if irritation occurs. keep out of reach of children.

PRINCIPAL DISPLAY PANEL

principal display panel:

CLINIQUE

ALMOST POWDER MAKEUP

SPF 15

NT WT. 0.35 OZ/ 10 g


clinique laboratories dist.
new york, ny 10022

INGREDIENTS AND APPEARANCE

ALMOST POWDER MAKEUP  SPF 15
titanium dioxide, octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-800
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	13.0 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SQUALANE (UNII: GW89575KF9)
BORON NITRIDE (UNII: 2U4T60A6YD)
CETYL OCTANOATE (UNII: 418Q5V6PLJ)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM PALMITOYL GLUTAMATE (UNII: KVF4175O54)
ALUMINUM OXIDE (UNII: LMI26O6933)
TOCOPHEROL (UNII: R0ZB2556P8)
PALMITIC ACID (UNII: 2V16EO95H1)
HEXANEDIOL (UNII: ZIA319275I)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TIN (UNII: 387GMG9FH5)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-800-01	1 in 1 CELLO PACK
1	NDC: 49527-800-02	10 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2007

Labeler - CLINIQUE LABORATORIES INC (173047747)

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
ASANUMA CORP LTD		700717762	manufacture