Label: AGE PERFECTING SPF 15 SUNSCREEN DAYLOGIC- ensulizole 1.70% octinoxate 7.50% 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 January 2, 2018

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  • Active ingredients                                 Purpose


    Ensulizole - 1.70%                                   Sunscreen
    Octinoxate - 7.50%                                  Sunscreen

  • PURPOSE

  • INDICATIONS & USAGE

    - helps prevent sunburn
    - if used as directed with other sun protection messures (see Directions) decreases the risk of skin cancer and early skin aging caused by sun.

  • Warnings

    For external use only
    Do not use on damaged or broken skin
    When using this product keep out of eyes. Rinse with water to remove.
    Stop use and ask a doctor if rash occurs
    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    apply liberally 15 minutes before sun exposure
    • reapply: • after 80 minutes of swimming or sweating
    • immediately after towel drying • at least every 2 hours
    • 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 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-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor

  • Inactive ingredients

    Water
    Glycerin
    Cyclopentasiloxane
    Butylene Glycol
    Caprylic/Capric Triglyceride
    Cetyl Alcohol
    Glyceryl Stearate
    PEG-100 Stearate
    Isopropyl Palmitate
    Stearic Acid
    C12-15 Alkyl Benzoate
    Propylene Glycol
    Triethanolamine
    Sorbitan Olivate
    Octadecenedioic Acid
    Phenoxyethanol
    Sorbitan Laurate
    Ceteareth-25
    Acetyl Hexapeptide-8
    Behenic Acid
    Cholesterol
    Ceramide NP
    Ceramide NS
    Ceramide EOS
    Ceramide EOP
    Ceramide AP
    Caprooyl Phytosphingosine
    Caprooyl Sphingosine
    Potassium Sorbate
    Xanthan Gum
    PEG-12 Dimethicone
    Ethyl Macadamiate
    1,2-Hexanediol
    Caprylyl Glycol
    Hydroxyethylcellulose
    Acetyl Dipeptide-1 Cetyl Ester

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    AGE PERFECTING SPF 15 SUNSCREEN   DAYLOGIC
    ensulizole 1.70% octinoxate 7.50% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-2222
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1.7 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    OCTADECENEDIOIC ACID (UNII: 565ZMT5QRG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    BEHENIC ACID (UNII: H390488X0A)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    CERAMIDE EOS (UNII: CR0J8RN66K)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-2222-31 in 1 CARTON08/30/2016
    170 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/30/2016
    Labeler - Rite Aid (014578892)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(11822-2222) , label(11822-2222)
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