MOISTURE SURGE TINTED MOISTURIZER SPF 15- titanium dioxide, octisalate, octinoxate lotion

MOISTURE SURGE by

Drug Labeling and Warnings

MOISTURE SURGE 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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

active ingredients: titanium dioxide 6.80% [] octisalate 5.00% [] octinoxate 2.80%

INACTIVE INGREDIENT

inactive ingredients: water\aqua\eau [] methyl trimethicone [] butylene glycol [] glycerin [] trimethylsiloxysilicate [] peg-10 dimethicone [] octyldodecyl neopentanoate [] lauryl peg-9 polydimethylsiloxyethyl dimethicone [] betula alba (birch) bark extract [] saccharomyces lysate extract [] aloe barbadensis leaf water [] ethylhexylglycerin [] dimethicone [] trehalose [] sorbitol [] sodium hyaluronate [] menthol [] trihydroxystearin [] hydroxyapatite [] tocopheryl acetate [] lecithin [] triethoxycaprylylsilane [] laureth-7 [] magnesium aluminum silicate [] cetrimonium chloride [] pvp [] dimethicone/peg-10/15 crosspolymer [] stearic acid [] aluminum hydroxide [] silica [] sodium chloride [] xanthan gum [] dipropylene glycol [] disodium edta [] sodium citrate [] sodium dehydroacetate [] chlorphenesin [] phenoxyethanol []  [+/- mica [] titanium dioxide (ci 77891) [] zinc oxide (ci 77947) [] iron oxides (ci 77491, ci 77492, ci 77499)

WARNINGS

warning: Keep out of eyes. stop use if irritation occurs.

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children

PRINCIPAL DISPLAY PANEL

principal display panel:

CLINIQUE

MOISTURE SURGE

TINTED MOISTURIZER

SPF 15

1 FL OZ LIQ/ 30 ML

CLINIQUE LABS DIST

NY NY 10022

INGREDIENTS AND APPEARANCE

MOISTURE SURGE  TINTED MOISTURIZER SPF 15
titanium dioxide, octisalate, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.8 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.8 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-007-01	1 in 1 CARTON
1	NDC: 49527-007-02	30 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2010

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