MATTE MOISTURIZER SPF 15 (OCTINOXATE OCTISALATE AVOBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]

MATTE MOISTURIZER SPF 15 (OCTINOXATE OCTISALATE AVOBENZONE) CREAM [KAMINS DERMATOLOGICS INC.]
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NDC 63550-191-03
Set ID 472f0b84-422e-4dd9-8c14-c335956be30c
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%

  • PURPOSE

    Purpose:

    Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • INDICATIONS & USAGE

    A light, comforting, daytime moisturizer, free of oil and fragrance to help delicately hydrate and protect oily skin. Contains our exclusive Bio-Maple compound, a complex humectant to help condition and hydrate skin. Also contains SPF 15 sunscreens to help protect skin from harmful UVA/UVB sunrays. May be used alone or as a base for oil-free makeup.

    Uses
    ■ Helps prevent sunburn.

    ■ Higher SPF gives more sunburn protection.

    ■ Provides high 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.

    Other information

    Sun alert: Limiting sun exposure, wearing 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.

    ■ Children under 6 months of ask: ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients:

    alcohol denat., ethyl macadamiate, tocopherol, malic acid, diethylhexyl 2,6-naphthalate, PPG-5-ceteth-20, acrylates/octylacrylamide copolymer, ethylene brassylate, lauryl PCA, tocopheryl acetate, acer saccharum (maple isolate), punica granatum (pomegranate) extract, propylene glycol, water, euterpe oleracea (acai) oil, retinyl palmitate, magnesium ascorbyl phosphate.

  • PRINCIPAL DISPLAY PANEL

    B. KAMINS

    MATTE MOISTURIZER SPF15

    50mL / 1.7 fl.oz

    DIN 02274345 Matte Moisturizer SPF front panel image

  • INGREDIENTS AND APPEARANCE
    MATTE MOISTURIZER SPF 15 
    octinoxate octisalate avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-191
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ACER SACCHARUM SAP (UNII: 75UOH57984)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    OCTOCRYLENE (UNII: 5A68WGF6WM)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    QUADROSILAN (UNII: C5KT601WPM)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63550-191-0350 mL in 1 BOX; Type 0: Not a Combination Product10/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/01/2010
    Labeler - Kamins Dermatologics Inc. (254050784)
    Registrant - Kamins Dermatologics Inc. (254050784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Odan Laboratories Ltd208585604manufacture(63550-191) , pack(63550-191)

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