Label: CLINIQUE SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25- avobenzone, octisalate, octocrylene, and oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-709-01 - 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 March 5, 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
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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
water • dimethicone • butylene glycol • butyloctyl salicylate • isononyl isononanoate • polyester-8 • silica • glycerin • polysilicone-11 • triticum vulgare (wheat bran) extract • algae extract • laminaria saccharina extract • olea europaea (olive) fruit extract • coffea robusta seed extract • echinacea pallida (coneflower) extract • rosmarinus officinalis (rosemary) extract • sea whip extract • astrocaryum murumuru seed butter • adenosine phosphate • trehalose • disodium nadh • padina pavonica (thallus) extract • creatine • sodium rna • caffeine • micrococcus lysate • nordihydroguaiaretic acid • sodium dna • phytosphingosine • linoleic acid • cholesterol • ascorbyl tocopheryl maleate • sodium hyaluronate • aminopropyl ascorbyl phosphate • tocopheryl acetate • trisiloxane • sucrose • laurdimonium hydroxypropyl hydrolyzed soy protein • lecithin • hexylene glycol • ethylhexyl stearate • ethylhexyl palmitate • decarboxy carnosine hcl • propylene glycol dicaprate • chamomilla recutita (matricaria) • zeolite • caprylyl glycol • polyethylene • xanthan gum • laureth-4 • laureth-23 • polysorbate 20 • ammonium acryloyldimethyltaurate/vp copolymer • acrylic acid/vp crosspolymer • arginine ferulate • tromethamine • disodium edta • phenoxyethanol [iln37043]
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
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INGREDIENTS AND APPEARANCE
CLINIQUE SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25
avobenzone, octisalate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-709 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mL in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.3 mL in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) WHEAT BRAN (UNII: 6L966A1IMR) saccharina latissima thallus (UNII: 68CMP2MB55) BLACK OLIVE (UNII: 2M6QWV94OC) ROBUSTA COFFEE BEAN (UNII: V5032728L7) ECHINACEA PALLIDA (UNII: 904CK3270L) ROSEMARY (UNII: IJ67X351P9) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) ADENOSINE PHOSPHATE (UNII: 415SHH325A) TREHALOSE (UNII: B8WCK70T7I) PADINA PAVONICA (UNII: 177U06NHZI) CREATINE (UNII: MU72812GK0) CAFFEINE (UNII: 3G6A5W338E) MASOPROCOL (UNII: 7BO8G1BYQU) LINOLEIC ACID (UNII: 9KJL21T0QJ) CHOLESTEROL (UNII: 97C5T2UQ7J) HYALURONATE SODIUM (UNII: YSE9PPT4TH) AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRISILOXANE (UNII: 9G1ZW13R0G) SUCROSE (UNII: C151H8M554) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) ETHYLHEXYL PALMITATE (UNII: 2865993309) PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY) MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) XANTHAN GUM (UNII: TTV12P4NEE) LAURETH-4 (UNII: 6HQ855798J) LAURETH-23 (UNII: N72LMW566G) POLYSORBATE 20 (UNII: 7T1F30V5YH) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) TROMETHAMINE (UNII: 023C2WHX2V) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-709-01 1 in 1 CARTON 1 50 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 04/01/2004 Labeler - CLINIQUE LABORATORIES INC (173047747) Establishment Name Address ID/FEI Business Operations ELGC Kabushiki Kaisha 712808195 RELABEL(49527-709) , REPACK(49527-709) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(49527-709) , RELABEL(49527-709) , REPACK(49527-709) Establishment Name Address ID/FEI Business Operations ARAMIS, INC 042918826 MANUFACTURE(49527-709) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(49527-709) , RELABEL(49527-709) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(49527-709) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(49527-709) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(49527-709) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(49527-709) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(49527-709) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 787336577 MANUFACTURE(49527-709) , RELABEL(49527-709) , REPACK(49527-709) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 949264774 MANUFACTURE(49527-709) , RELABEL(49527-709) , REPACK(49527-709) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 618107429 MANUFACTURE(49527-709) , RELABEL(49527-709) , REPACK(49527-709) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(49527-709) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(49527-709)
