Label: PHELITYL DAY SPF 15 cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 3, 2024

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

  • ACTIVE INGREDIENTS

    Avobenzone 2%,

    Octinoxate 5%

  • Purpose

    Sunscreen

  • Uses

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

    • Apply liberally 15 minutes before sun exposure
    • reapply: after 40 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, Glyceryl Stearate, Butylene Glycol, Cetyl Alcohol, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Silica, Butyrospermum Parkii (Shea) Butter, Emu Oil, Glycerin, PEG-100 Stearate, Polyglyceryl-3 Laurate, Taraktogenos Kurzii Seed Oil, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Extract, Camellia Sinensis Leaf Extract, Panax Ginseng Root Extract, Allantoin, Carbomer, Ceteth-20, Disodium EDTA, Ethylhexylglycerin, O-Cymen-5-Ol, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Fragrance, Steareth-2, Steareth-20, Triethanolamine, Phenoxyethanol.

  • Other information

    • protect this product from excessive heat and direct sun
  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Product label

    PHELITYL DAY SPF 15

  • INGREDIENTS AND APPEARANCE
    PHELITYL DAY SPF 15 
    phelityl day spf 15 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59735-475
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    EMU OIL (UNII: 344821WD61)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CETETH-20 (UNII: I835H2IHHX)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYDNOCARPUS KURZII SEED OIL (UNII: N757YEZ18Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    STEARETH-2 (UNII: V56DFE46J5)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59735-475-011 in 1 CARTON04/10/2013
    190 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/10/2013
    Labeler - MANA PRODUCTS, INC. (078870292)
    Establishment
    NameAddressID/FEIBusiness Operations
    MANA PRODUCTS, INC032870270manufacture(59735-475)
    Establishment
    NameAddressID/FEIBusiness Operations
    MANA PRODUCTS, INC.078870292manufacture(59735-475)