DAY C (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]

DAY C (AVOBENZONE OCTINOXATE OXYBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]
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NDC 63550-120-03
Set ID 505b59f9-9203-467c-af39-95f7087c9288
Category HUMAN OTC DRUG LABEL
Packager Kamins Dermatologics Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients:


    AVOBENZONE 2 %



    OCTINOXATE 7 %


    OXYBENZONE 5 %

  • PURPOSE

    Purpose: Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • INDICATIONS & USAGE

    This light weight, non-greasy day cream preserves your skin with a healthier protective shield, essential nutrients and continuous moisture release suited to a multitude of daytime environmental conditions. Our Bio-maple technology helps fight the look of wrinkles, moisturizes and provides radiance throuhout the day. A perfect primer for mak-up. For maximum benefits, may be reapplied over make-up as often as needed. Also useful for soothing post-microdermabrasion skin.


    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.



    Sun alert: limiting sun exposure, earing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.





  • DOSAGE & ADMINISTRATION

    Directions

    Apply liberally and evenly each morning to cleansed face and neck, before sun exposure and as needed. reapply after swimming, washing/towel drying or perspiring heavily.

    Children under 6 months of age: ask a doctor.




  • INACTIVE INGREDIENT

    Inactive ingredients:

    aqua/water/eau, glyceryl stearate SE, soluble collagen, butylene glycol, acer saccharum (maple isolate), cetyl alcohol, ceteareth-12, coco-caprylate/caprate, squalane, magnesium aluminum silicate, cyclotetrasiloxane, cyclopentasiloxane, PEG/PPG-18/18 dimethicone, PEG-16 soy sterol, dimethicone, polysorbate 80, prunus armeniaca (apricot) kernel oil, retinyl palmitate, tocopheryl acetate, sodium hydroxide, citric acid, phenoxyethanol, caprylyl glycol, sorbic acid, parfum/fragrance. Contains oxybenzone

  • PRINCIPAL DISPLAY PANEL

    B. KAMINS

    DAY CREAM SPF15

    50mL / 1.7 fl.oz

    DIN 0246708

    Day Cream SPF15 front panel image

  • INGREDIENTS AND APPEARANCE
    DAY C 
    avobenzone octinoxate oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    SQUALANE (UNII: GW89575KF9)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63550-120-0350 g in 1 BOX; Type 0: Not a Combination Product10/01/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/01/2003
    Labeler - Kamins Dermatologics Inc. (254050784)
    Registrant - Kamins Dermatologics Inc. (254050784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Odan Laboratories Ltd208585604manufacture(63550-120) , pack(63550-120)

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