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DAY L (Kamins Dermatologics Inc.)

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LOTION 50 mL in 1 BOX (63550-122-03) Label Information

Complete DAY L Information

  • ACTIVE INGREDIENT

    Active ingredients:

    AVOBENZONE 2.5 %

    OCTINOXATE 7.5 %

    OCTISALATE 4.0 %

     
  • PURPOSE

    Purpose: Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of children’s reach.

  • INDICATIONS & USAGE

    A LIGHT, SILKY LOTION THAT DIFFUSES A BLEND OF MOISTURIZERS, ANTI-OXYDANT VOTMINS INTO THE SKIN TO ENHANCE DAY LONG COMFORT AND HYDRATION. THE SKIN'S OUTER LAYERS ARE COVERED WITH A PROTECTIVE SHIELD, PRODUCING A HEALTHY, LUMINESCENT GLOW. 

    Uses

    â–  Helps prevent sunburn.

    â–  Higher SPF gives more sunburn protection.

    â–  Provides moderate protection against sunburn.


  • WARNINGS

    Warnings

    For external use only.

    When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.

    Stop use and ask a doctor if rash or irritation develops and lasts.

    If swallowed, seek medical assistance or contact a Poison Control Center immediately.






  • DOSAGE & ADMINISTRATION

    Directions

    Apply liberally and evenly each morning to cleansed face and neck, before sun exposure and as needed.
    Children under 6 months of age: ask a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients:  aqua/water/eau, acer saccharum (maple isolate), butylene glycol, hydrolyzed collagen, hydrolyzed elastin, octocrylene, cetyl alcohol, glyceryl stearate SE, ceteareth-12, cyclotetrasiloxane, cyclopentasiloxane, PEG/PPG-18/18 dimethicone, coco- caprylate/caprate, polysorbate-80, carbomer, tocopheryl acetate, retinyl palmitate, sodium hydroxide, phenoxyethanol, caprylyl glycol, sorbic acid, parfum/fragrance

  • PRINCIPAL DISPLAY PANEL

    B. KAMINS

    DAY LOTION SPF15

    50mL / 1.7 fl.oz

    DIN 02248016


    Day Lotion front panel image


  • INGREDIENTS AND APPEARANCE
    DAY L 
    avobenzone octisalate octinoxate lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63550-122
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 25 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 40 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ACER SACCHARUM SAP (UNII: 75UOH57984)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) (UNII: ZR28QKN0WT)  
    OCTOCRYLENE (UNII: 5A68WGF6WM)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARBOMER 934 (UNII: Z135WT9208)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63550-122-03 50 mL in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 03/07/2012
    Labeler - Kamins Dermatologics Inc. (254050784)
    Registrant - Kamins Dermatologics Inc. (254050784)
    Establishment
    Name Address ID/FEI Business Operations
    Kamins Dermatologics Inc. 254050784 manufacture, pack, label