Label: CLINIQUE SKIN SUPPLIES FOR MEN AGE DEFENSE HYDRATOR BROAD SPECTRUM SPF 15- avobenzone, octinoxate, and octisalate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-035-01 - 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 June 5, 2013
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 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
water\aqua\eau • octyldodecyl neopentanoate • hdi/trimethylol hexyllactone crosspolymer • neopentyl glycol diheptanoate • dimethicone • silica • steareth-21 • butylene glycol • pentylene glycol • sigesbeckia orientalis (st. paul's wort) extract • rosmarinus officinalis (rosemary) extract • polyethylene • coffea robusta seed extract • polygonum cuspidatum root extract • laurdimonium hydroxypropyl hydrolyzed soy protein • saccharomyces lysate extract • steareth-2 • astrocaryum murumuru seed butter • glycerin • hydrogenated lecithin • ethylhexyl stearate • polysilicone-11 • sucrose • pvp/hexadecene copolymer • acetyl glucosamine • isohexadecane • ethylhexylglycerin • caffeine • trimethylsiloxysilicate • glyceryl polymethacrylate • acrylates/c10-30 alkyl acrylate crosspolymer • linoleic acid • cholesterol • polysorbate 80 • palmitoyl oligopeptide • ethylhexyl palmitate • tromethamine • tetrahexyldecyl ascorbate • adenosine phosphate • peg-8 • lecithin • sodium dna • arginine ferulate • acetyl hexapeptide-8 • sodium hyaluronate • phytantriol • caprylyl glycol • xanthan gum • ascorbyl tocopheryl maleate • phytosphingosine • propylene glycol dicaprate • acrylamide/sodium acryloyldimethyltaurate copolymer • hexylene glycol • nordihydroguaiaretic acid • potassium sulfate • sodium carbomer • disodium edta • sorbic acid • chlorphenesin • potassium sorbate • phenoxyethanol [iln34202]
- Other information
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
CLINIQUE SKIN SUPPLIES FOR MEN AGE DEFENSE HYDRATOR BROAD SPECTRUM SPF 15
avobenzone, octinoxate, and octisalate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.0203 g in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.076 g in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.0507 g in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) octyldodecyl neopentanoate (UNII: X8725R883T) neopentyl glycol diheptanoate (UNII: 5LKW3C543X) dimethicone (UNII: 92RU3N3Y1O) silicon dioxide (UNII: ETJ7Z6XBU4) steareth-21 (UNII: 53J3F32P58) butylene glycol (UNII: 3XUS85K0RA) pentylene glycol (UNII: 50C1307PZG) rosemary (UNII: IJ67X351P9) high density polyethylene (UNII: UG00KM4WR7) robusta coffee bean (UNII: V5032728L7) polygonum cuspidatum root (UNII: 7TRV45YZF7) saccharomyces lysate (UNII: R85W246Z1C) steareth-2 (UNII: V56DFE46J5) astrocaryum murumuru seed butter (UNII: 12V64UPU6R) glycerin (UNII: PDC6A3C0OX) ethylhexyl stearate (UNII: EG3PA2K3K5) sucrose (UNII: C151H8M554) n-acetylglucosamine (UNII: V956696549) isohexadecane (UNII: 918X1OUF1E) ethylhexylglycerin (UNII: 147D247K3P) caffeine (UNII: 3G6A5W338E) linoleic acid (UNII: 9KJL21T0QJ) cholesterol (UNII: 97C5T2UQ7J) polysorbate 80 (UNII: 6OZP39ZG8H) palmitoyl oligopeptide (UNII: HO4ZT5S86C) ethylhexyl palmitate (UNII: 2865993309) tromethamine (UNII: 023C2WHX2V) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) adenosine phosphate (UNII: 415SHH325A) polyethylene glycol 400 (UNII: B697894SGQ) acetyl hexapeptide-8 (UNII: L4EL31FWIL) hyaluronate sodium (UNII: YSE9PPT4TH) phytantriol (UNII: 8LVI07A72W) caprylyl glycol (UNII: 00YIU5438U) xanthan gum (UNII: TTV12P4NEE) ascorbyl tocopheryl maleate (UNII: D2G6259XR5) phytosphingosine (UNII: GIN46U9Q2Q) propylene glycol dicaprate (UNII: U783H9JHWY) hexylene glycol (UNII: KEH0A3F75J) masoprocol (UNII: 7BO8G1BYQU) potassium sulfate (UNII: 1K573LC5TV) edetate disodium (UNII: 7FLD91C86K) sorbic acid (UNII: X045WJ989B) chlorphenesin (UNII: I670DAL4SZ) potassium sorbate (UNII: 1VPU26JZZ4) phenoxyethanol (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-035-01 1 in 1 CARTON 1 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 07/14/2010 Labeler - CLINIQUE LABORATORIES INC. (173047747) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(49527-035) , REPACK(49527-035) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(49527-035) , RELABEL(49527-035) , REPACK(49527-035) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(49527-035) , RELABEL(49527-035) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(49527-035) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(49527-035) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(49527-035) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(49527-035) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(49527-035) , RELABEL(49527-035) , REPACK(49527-035) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(49527-035) , RELABEL(49527-035) , REPACK(49527-035) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(49527-035) , RELABEL(49527-035) , REPACK(49527-035) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(49527-035) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(49527-035) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(49527-035) , RELABEL(49527-035)
