Label: CLINIQUE CX PROTECTIVE BASE SPF 40- octinoxate, octisalate, zinc oxide,titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-953-01, 49527-953-02 - Packager: CLINIQUE LABORATORIES INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 3, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLINIQUE CX PROTECTIVE BASE SPF 40
octinoxate, octisalate, zinc oxide,titanium dioxide creamProduct 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
