DAY L (AVOBENZONE OCTISALATE OCTINOXATE) LOTION [KAMINS DERMATOLOGICS INC.]

DAY L (AVOBENZONE OCTISALATE OCTINOXATE) LOTION [KAMINS DERMATOLOGICS INC.]
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NDC 63550-122-03
Set ID a70592cb-b4d4-4e65-9281-6b0a0461a2ba
Category HUMAN OTC DRUG LABEL
Packager Kamins Dermatologics Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • 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 the reach of children.

  • 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

    ■ Helps prevent sunburn.

    ■ Higher SPF gives more sunburn protection.

    ■ 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    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 GLYCOL 1000 (UNII: U076Q6Q621)  
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63550-122-0350 mL in 1 BOX; Type 0: Not a Combination Product03/01/2004
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/01/2004
    Labeler - Kamins Dermatologics Inc. (254050784)
    Registrant - Kamins Dermatologics Inc. (254050784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Odan Laboratories Ltd208585604manufacture(63550-122) , pack(63550-122)

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