NDC | 49527-708-01, 49527-708-02 |
Set ID | e5069e15-09c0-4eb1-8030-bbe65e5a4a76 |
Category | HUMAN OTC DRUG LABEL |
Packager | CLINIQUE LABORATORIES INC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
inactive ingredients: water [] dimethicone [] petrolatum [] butylene glycol [] butyloctyl salicylate [] polyglyceryl-2 triisostearate [] caprylic/capric/myristic/stearic triglyceride [] polyester-8 [] glyceryl stearate [] peg-100 stearate [] coffea robusta seed extract [] echinacea pallida (coneflower) extract [] rosmarinus officinalis (rosemary) extract [] sea whip extract [] isopropyl ppg-2-isodeceth-7 carboxylate [] padina pavonica (thallus) extract [] micrococcus lysate [] disodium nadh [] trehalose [] creatine [] sodium rna [] caffeine [] nordihydroguaiaretic acid [] sodium dna [] astrocaryum murumuru seed butter [] phytosphingosine [] linoleic acid [] cholesterol [] ascorbyl tocopheryl maleate [] algae extract [] sodium hyaluronate [] aminopropyl ascorbyl phosphate [] tocopheryl acetate [] adenosine phosphate [] laurdimonium hydroxypropyl hydrolyzed soy protein [] chamomilla recutita (matricaria) [] decarboxy carnosine hcl [] ethylhexyl stearate [] caprylyl glycol [] isohexadecane [] polyethylene [] zeolite [] lecithin [] behenyl alcohol [] xanthan gum [] potassium sulfate [] polysorbate 80 [] steareth-21 [] acrylamide/sodium acryloyldimethyltaurate copolymer [] ammonium acryloyldimethyltaurate/vp copolymer [] sucrose [] tromethamine [] carbomer [] glycerin [] ethylhexyl palmitate [] arginine ferulate [] propylene glycol dicaprate [] hexylene glycol [] disodium edta [] phenoxyethanol - WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUPER DEFENSE SUPERDEFENSE AGE DEFENSE MOISTURIZER SPF 25 VERY DRY SKIN
oxybenzone, octisalate, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-708 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5.0 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 mL in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) PETROLATUM (UNII: 4T6H12BN9U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) ROBUSTA COFFEE BEAN (UNII: V5032728L7) ECHINACEA PALLIDA (UNII: 904CK3270L) ROSEMARY (UNII: IJ67X351P9) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) TREHALOSE (UNII: B8WCK70T7I) CREATINE (UNII: MU72812GK0) CAFFEINE (UNII: 3G6A5W338E) MASOPROCOL (UNII: 7BO8G1BYQU) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) LINOLEIC ACID (UNII: 9KJL21T0QJ) CHOLESTEROL (UNII: 97C5T2UQ7J) LAMINARIA DIGITATA (UNII: 15E7C67EE8) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ADENOSINE PHOSPHATE DISODIUM (UNII: T1WZ11DSRN) MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ISOHEXADECANE (UNII: 918X1OUF1E) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) DOCOSANOL (UNII: 9G1OE216XY) XANTHAN GUM (UNII: TTV12P4NEE) POTASSIUM SULFATE (UNII: 1K573LC5TV) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STEARETH-21 (UNII: 53J3F32P58) SUCROSE (UNII: C151H8M554) TROMETHAMINE (UNII: 023C2WHX2V) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYL PALMITATE (UNII: 2865993309) PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY) HEXYLENE GLYCOL (UNII: KEH0A3F75J) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-708-01 1 in 1 CARTON 1 NDC:49527-708-02 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 04/01/2008 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