CLINIQUE CX PROTECTIVE BASE SPF 40- octinoxate, octisalate, zinc oxide,titanium dioxide cream

CLINIQUE CX by

Drug Labeling and Warnings

CLINIQUE CX 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: octinoxate 7.50% [] octisalate 5.00% [] zinc oxide 4.60% [] titanium dioxide 1.70%

INACTIVE INGREDIENT

inactive ingredients: water (aqua purificata) purified [] butylene glycol [] c12-15 alkyl benzoate [] dimethicone [] jojoba esters [] caprylic/capric triglyceride [] cetearyl alcohol [] silica [] micrococcus lysate [] gentiana lutea (gentian) root extract [] coffea robusta seed extract [] helianthus annuus (sunflower) seedcake [] cucumis sativus (cucumber) fruit extract [] sea whip extract [] cholesterol [] astrocaryum murumuru butter [] hordeum vulgare (barley) extract [] linoleic acid [] butyrospermum parkii (shea butter) [] caffeine [] salvia sclarea (clary) extract [] sodium rna [] sodium hyaluronate [] phytosphingosine [] tocopheryl acetate [] sodium dna [] cetearyl glucoside [] zeolite [] stearic acid [] chamomilla recutita (matricaria) [] sucrose [] peg-100 stearate [] lecithin [] trehalose [] hydrogenated lecithin [] hexylene glycol [] propylene glycol dicaprate [] tricaprylin [] polyhydroxystearic acid [] polyethylene [] methyl gluceth-20 [] ethylhexyl stearate [] carbomer [] behenyl alcohol [] alumina [] ethylhexyl palmitate [] caprylyl glycol [] cetyl alcohol [] triethoxycaprylylsilane [] xanthan gum [] aluminum stearate [] disodium edta [] bht [] phenoxyethanol [] mica [] titanium dioxide (ci 77891) [] 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 chidren

PRINCIPAL DISPLAY PANEL

principal display panel:

CLINIQUE CX

PROTECTIVE BASE

SPF 40

• daily protection for easily stressed skin
• calms and comforts

CLINIQUE LABORATORIES

1.7 fl oz/50 ml


clinique laboratories, distr.
new york, ny
10022

clinique.com

INGREDIENTS AND APPEARANCE

CLINIQUE CX  PROTECTIVE BASE SPF 40
octinoxate, octisalate, zinc oxide,titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-953
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.6 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.7 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-953-01	1 in 1 CARTON
1	NDC: 49527-953-02	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	05/01/2005

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