CALLYSSEE BEAUTY FACEGUARD SKIN PROTECTING FACIAL BALM (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [EMILIA PERSONAL CARE INC]

CALLYSSEE BEAUTY FACEGUARD SKIN PROTECTING FACIAL BALM (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [EMILIA PERSONAL CARE INC]
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NDC 42421-802-16
Set ID ed9bab86-2ad2-419e-8d38-9ccdea0b00bb
Category HUMAN OTC DRUG LABEL
Packager Emilia Personal Care Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients

    Avobenzone (Butyl Methoxydibenzoylmethane) 3.0%

    Homosalate, 10.0%

    Octisalate, (Ehtylhexyl Salicylate) 5.0%

    Octocrylene, 2.0%

    Oxybenzone (Benzophenone-3) 4.0%

  • PURPOSE

    Purpose

    Sunscreen

    Sunscreen

    Sunscreen

    Sunscreen

    Sunscreen

  • INDICATIONS & USAGE

    Uses

    -helps prevent sunburn

    -if used as directed with other sun protection measures (see

    Directions), decreases the risk of kin cancer and early skin aging

    caused by the sun.

  • WARNINGS

    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.

    Stop use and ask a doctor   -if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children  -If swallowed, get medical help or contact

    a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    -apply liberally 15 minutes before sun exposure

    -reapply at least every two hours

    -use water resistant sunscreen if swimming or sweating

    -children under 6 months of age: ask a doctor

    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 witha Broad Spectrum SPF value 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-sleeved shirts, pants, hats and sunglasses

  • STORAGE AND HANDLING

    Other information - protect the product in this container from

    excessive heat and direct sun

  • INACTIVE INGREDIENT

    Inactive ingredients:  isohexadecane, dimethicone/bis-isobutyl

    PPG-20 crosspolymer, caprylic/capric triglyceride,

    fragrance/parfum, tocopheryl acetate (vitamin E), bisabolol, coffee

    arabica seed extract

  • SPL UNCLASSIFIED SECTION

  • QUESTIONS

    Questions {or comments}?  1-844-331-1224

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CALLYSSEE   BEAUTY FACEGUARD SKIN PROTECTING FACIAL BALM
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42421-802
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 50 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BIS-ISOBUTYLENE PPG-20 (UNII: 5R9772B6IK)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42421-802-1650 mL in 1 TUBE; Type 0: Not a Combination Product12/26/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/26/2016
    Labeler - Emilia Personal Care Inc (965445112)

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