Label: PREMIUM AGE PROTECTOR- ethylhexyl methoxyci nnamate cream cream

  • 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 February 5, 2022

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Active Ingredients: ethylhexyl methoxy­cinnamate and octocrylene

  • Inactive Ingredients

    Other Ingredients: Aqua [water], propylheptyl caprylate, octocrylene, butylene glycol, methyl glucose sesquistearate, hydrogenated polyisobutene, sodium potassium aluminum silicate, gly­cerin, steareth-21, BIS-ethylhexyloxyphenol, methoxyphenyl triazine, ethylhexyl triazone, cetearyl alcohol, glyceryl stearate, phenyl trimethi­cone, sigesbeckia orientalis extract, rabdosia rubescens extract, tomes officinalis (mushroom] extract, retinyl palmitate, helianthus annuus [sunflower] seed oil, faex extract [yeast extract], aluminum hydroxide, soy isoflavones, lepidium sativum sprout extract, PEG-40 hydrogenated castor oil, polysorbate 80, lecithin, silica, hydrogen dimethicone, sodium levulinate, levulinic acid, titanium dioxide (nano), ascorbyl sodium levulinate, levulinic acid, titanium dioxide (nano), ascorbyl palmitate, tocopherol, BHT, disodium EDTA, alcohol, ethylhexyl-1) glycerin, citric acid, parfum [fragrance], phenoxyethanol, sodium benzoate, sodium dehydroacetate, methyl benzoate, Cl 77 891 [titanium dioxide], Cl 15 985 [yellow 6]

  • Principlay Panel

    4129 Premium Age Protector SPF30

    Disclaimer: Most OTC drugs are not review and approved by FDA; however, they are marketed if they comply with applicable and policies

    Active Ingredients: ethylhexyl methoxy­cinnamate and octocrylene

    Other Ingredients: Aqua [water], propylheptyl caprylate, octocrylene, butylene glycol, methyl glucose sesquistearate, hydrogenated polyisobutene, sodium potassium aluminum silicate, gly­cerin, steareth-21, BIS-ethylhexyloxyphenol, methoxyphenyl triazine, ethylhexyl triazone, cetearyl alcohol, glyceryl stearate, phenyl trimethi­cone, sigesbeckia orientalis extract, rabdosia rubescens extract, tomes officinalis (mushroom] extract, retinyl palmitate, helianthus annuus [sunflower] seed oil, faex extract [yeast extract], aluminum hydroxide, soy isoflavones, lepidium sativum sprout extract, PEG-40 hydrogenated castor oil, polysorbate 80, lecithin, silica, hydrogen dimethicone, sodium levulinate, levulinic acid, titanium dioxide (nano), ascorbyl sodium levulinate, levulinic acid, titanium dioxide (nano), ascorbyl palmitate, tocopherol, BHT, disodium EDTA, alcohol, ethylhexyl-1) glycerin, citric acid, parfum [fragrance], phenoxyethanol, sodium benzoate, sodium dehydroacetate, methyl benzoate, Cl 77 891 [titanium dioxide], Cl 15 985 [yellow 6]

    Direction: Every morning, after cleansing evenly spread a small amount of cream over you face, neck and the area above your neckline and gently rub it in. Avoid the skin around your eyes

    4129 Premium Age Protector SPF30

    4129 Premium Age Protector SPF30

  • INGREDIENTS AND APPEARANCE
    PREMIUM AGE PROTECTOR 
    ethylhexyl methoxyci nnamate cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70493-429
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.49 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    SIGESBECKIA ORIENTALIS FLOWERING TOP (UNII: 6UL878YAR7)  
    POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)  
    STEARETH-21 (UNII: 53J3F32P58)  
    BEMOTRIZINOL (UNII: PWZ1720CBH)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
    YEAST (UNII: 3NY3SM6B8U)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SOY ISOFLAVONES (UNII: 71B37NR06D)  
    GARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
    WATER (UNII: 059QF0KO0R)  
    METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)  
    ISODON RUBESCENS TOP (UNII: 03NNJ0PH79)  
    LARICIFOMES OFFICINALIS FRUITING BODY (UNII: 7IFM8431X3)  
    LEVULINIC ACID (UNII: RYX5QG61EI)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    METHYL BENZOATE (UNII: 6618K1VJ9T)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70493-429-011 in 1 BOX02/16/2022
    150 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/16/2022
    Labeler - Inspira: Cosmetics GmbH (329455898)
    Registrant - Inspira: Cosmetics GmbH (329455898)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspira: Cosmetics GmbH329455898manufacture(70493-429)