DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40- octinoxate, titanium dioxide, octisalate cream

DERMA WHITE by

Drug Labeling and Warnings

DERMA WHITE by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABS 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: octinoxate 7.50% [] titanium dioxide 5.20% [] octisalate 2.00%

INACTIVE INGREDIENT

inactive ingredients: water [] butylene glycol [] c12-15 alkyl benzoate [] cetyl alcohol [] laureth-4 [] chamomilla recutita (matricaria) extract [] saccharomyces cerevisiae extract [] rosmarinus officinalis (rosemary) leaf extract [] chamomilla recutita (matricaria) flower extract [] gentiana lutea (gentian) root extract [] yeast extract\faex\extrait de levure [] oryza sativa (rice) bran extract [] polyethylene [] hordeum vulgare (barley) extract\extrait d'orge [] salicornia herbacea extract [] rosa roxburghii fruit extract [] peg-100 stearate [] citrus unshiu peel extract [] cucumis sativus (cucumber) fruit extract [] plankton extract [] pantethine [] porphyra yezoensis (algae) extract [] helianthus annuus (sunflower) seedcake [] hydrogenated lecithin [] caffeine [] polyglyceryl-3 beeswax [] acetyl glucosamine [] pvp/hexadecene copolymer [] squalane [] polyhydroxystearic acid [] tocopheryl acetate [] isohexadecane [] methicone [] propylene glycol dicaprate [] dipotassium glycyrrhizate [] zeolite [] nylon-12 [] magnesium ascorbyl phosphate [] polysorbate 80 [] hexylene glycol [] caprylyl glycol [] acrylamide/sodium acryloyldimethyltaurate copolymer [] isostearic acid [] calcium chloride [] xanthan gum [] alumina [] disodium edta [] bht [] phenoxyethanol [] 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

DERMA WHITE

CITY BLOCK

ANTI-POLLUTION SPF 40


ALL SKIN TYPES


1 FL OZ LIQ / 30 ML


CLINIQUE LABS DISTR.
NEW YORK, NY 10022


 

 

INGREDIENTS AND APPEARANCE

DERMA WHITE  CITY BLOCK ANTI-POLLUTION SPF40
octinoxate, titanium dioxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.2 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.0 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SQUALANE (UNII: GW89575KF9)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-008-01	1 in 1 CARTON
1	NDC: 49527-008-02	30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2010

Labeler - CLINIQUE LABS 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