Label: CITY BASE COMPACT FOUNDATION SPF 15- titanium dioxide paste
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-015-01, 49527-015-02 - 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 June 19, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS:
- PURPOSE
- USE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- SPL UNCLASSIFIED SECTION
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DIRECTIONS
For sunscreen use:
* apply liberally 15 minutes before sun exposure
* reapply at least every two hours
* use a water resistant sunscreen if swimming or sweating
* Sun Protection Measures.
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
o limit time in the sun, especially from 10 a.m.–2 p.m.
o wear long-sleeved shirts, pants, hats and sunglasses
* children under 6 months of age: ask a doctor -
INACTIVE INGREDIENTS
ingredients: propylene glycol dicaprylate/dicaprate [] nylon-12 [] coco-caprylate/caprate [] dimethicone [] polyethylene [] copernicia cerifera (carnauba) wax\cera carnauba\cire de carnauba [] cetyl ricinoleate [] polysilicone-11 [] barium sulfate [] hydrogenated coco-glycerides [] tribehenin [] aluminum starch octenylsuccinate [] euphorbia cerifera (candelilla) wax\candelilla cera\cire de candelilla [] magnesium myristate [] bht [] [+/- mica [] iron oxides (ci 77491, ci 77492, ci 77499) [] titanium dioxide (ci 77891)]
- OTHER INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CITY BASE COMPACT FOUNDATION SPF 15
titanium dioxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.8 g in 100 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) DIMETHICONE (UNII: 92RU3N3Y1O) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CARNAUBA WAX (UNII: R12CBM0EIZ) CETYL RICINOLEATE (UNII: 1P677500YD) BARIUM SULFATE (UNII: 25BB7EKE2E) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) TRIBEHENIN (UNII: 8OC9U7TQZ0) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) CANDELILLA WAX (UNII: WL0328HX19) MAGNESIUM MYRISTATE (UNII: Z1917F0578) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-015-01 1 in 1 CARTON 1 NDC:49527-015-02 14 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/1998 Labeler - CLINIQUE LABORATORIES INC. (173047747) Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Inc 042918826 manufacture Establishment Name Address ID/FEI Business Operations Northtec Keystone 949264774 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Bristol 959338336 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Keystone 943871157 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. 205952385 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd. 244669714 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 Centre 208579636 repack, relabel Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 manufacture 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 Pennsylvania Logistics Center (PALC) 078364654 repack, relabel