Label: CLINIQUE MOISTURE SURGE CC COMPACT HYDRATING COLOUR CORRECTOR BROAD SPECTRUM SPF 25- octinoxate and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-040-01 - 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 January 6, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
- Warnings
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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
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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:- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age:
ask a doctor
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Inactive ingredients
isotridecyl isononanoate • dimethicone • squalane • dextrin palmitate • dimethicone/vinyl dimethicone crosspolymer • vinyl dimethicone/methicone silsesquioxane crosspolymer • talc • phytosteryl/octyldodecyl lauroyl glutamate • sorbitan sesquiisostearate • alumina • glycerin • salicylic acid • silica dimethyl silylate • tocopherol • sodium hyaluronate • nylon-12 • methyl methacrylate crosspolymer • hdi/trimethylol hexyllactone crosspolymer • stearic acid • triethoxycaprylylsilane • silica • magnesium myristate • tin oxide • dehydroacetic acid • [+/- titanium dioxide (ci 77891) • mica • iron oxides (ci 77499) • iron oxides (ci 77491) • iron oxides (ci 77492)] [iln40504]
- Other information
- PRINCIPAL DISPLAY PANEL - 10 g Tube Carton
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INGREDIENTS AND APPEARANCE
CLINIQUE MOISTURE SURGE CC COMPACT HYDRATING COLOUR CORRECTOR BROAD SPECTRUM SPF 25
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5.5 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.7 g in 100 g Inactive Ingredients Ingredient Name Strength ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT) DIMETHICONE (UNII: 92RU3N3Y1O) SQUALANE (UNII: GW89575KF9) TALC (UNII: 7SEV7J4R1U) ALUMINUM OXIDE (UNII: LMI26O6933) GLYCERIN (UNII: PDC6A3C0OX) SALICYLIC ACID (UNII: O414PZ4LPZ) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) TOCOPHEROL (UNII: R0ZB2556P8) HYALURONATE SODIUM (UNII: YSE9PPT4TH) NYLON-12 (UNII: 446U8J075B) STEARIC ACID (UNII: 4ELV7Z65AP) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM MYRISTATE (UNII: Z1917F0578) STANNIC OXIDE (UNII: KM7N50LOS6) DEHYDROACETIC ACID (UNII: 2KAG279R6R) MICA (UNII: V8A1AW0880) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-040-01 1 in 1 CARTON 1 10 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 11/01/2013 Labeler - CLINIQUE LABORATORIES INC. (173047747) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(49527-040) , REPACK(49527-040) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(49527-040) , RELABEL(49527-040) , REPACK(49527-040) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(49527-040) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(49527-040) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(49527-040) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(49527-040) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(49527-040) , RELABEL(49527-040) , REPACK(49527-040) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(49527-040) , RELABEL(49527-040) , REPACK(49527-040) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(49527-040) , RELABEL(49527-040) , REPACK(49527-040) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(49527-040) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(49527-040) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(49527-040) , RELABEL(49527-040) Establishment Name Address ID/FEI Business Operations NIPPON SHIKIZAI 692572936 MANUFACTURE(49527-040)
