CYANTIFIC PROTECTING DAILY BROAD SPECTRUM SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, HOMOSALATE, OCTOCRYLENE) CREAM [BEAGLE BIOPRODUCTS INC.]

CYANTIFIC PROTECTING DAILY BROAD SPECTRUM SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, HOMOSALATE, OCTOCRYLENE) CREAM [BEAGLE BIOPRODUCTS INC.]
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NDC 70820-751-01
Set ID c4503650-242c-43bf-8d55-f240120a9215
Category HUMAN OTC DRUG LABEL
Packager Beagle Bioproducts Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • DRUG FACTS

  • ACTIVE INGREDIENTS

    Butyl Methoxydibenzoylmethane 2%

    Ethylhexyl Methexycinnamate 1%

    Ethylhexyl Salicylate 4%

    Homosalate 7%

    Octocrylene 7%

    PURPOSE

    Sunscreen

  • USES

    • helps prevent sunburn

  • WARNINGS

    • For external use only

    Do not use

    on damaged or broken skin

    When using this product

    keep out of eyes

    Stop use and ask a doctor

    if rash occurs

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • apply liberally 15 minutes before sun exposure • reapply at least every 2 hours • use water resistant sunscreen if swimming or sweating • 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 with a broad spectrum SPF value of 15 or higher and other sun protection measures including • limit the time in the sun, especially between 10 a.m.–2 p.m. • wear long sleeve shirts, pants, hats and sunglasses • children under the age of 6 months: ask a doctor

  • OTHER INFORMATION

    • protect this product from excessive heat and direct sun

  • INACTIVE INGREDIENTS

    Water, Caprylic/Capric Triglycerides, Tridecyl Neopentanoate, Cyclopentasiloxane, Niacinamide, Anabaena Flosaquae/Aphanizomenon
    Flosaquae/Coelosphaerium Kuetzingianum/Microcytis Aeruginosa/Oscillatoria Princeps Extract, Astrocaryum Murumuru Seed Butter, Glycerin, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, C12-15 Alkyl Benzoate, Dimethicone Crosspolymer, Cetearyl Alcohol, Ceteth-20, Glyceryl Stearate, Tapioca Starch Polymethylsilsesquioxane, Sodium Polyacrylate, Laureth-7, Crambe Abyssinica Seed Oil, Sorbitan Oleate, Behenyl Alcohol, Palmitic Acid, Stearic Acid, Lecithin, Lauryl Alcohol, Myristyl Alcohol, Cetyl Alcohol, Glyceryl Dilaurate, Dimethiconol, C13–C16 Isoparaffin, C12–C14 Isoparaffin, C13–C15 Alkane, Tocopheryl Acetate (Vitamin E), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate Crosspolymer-11, Phenoxyethanol, Caprylyl Glycol, Sodium PCA, Potassium Hydroxide, Fragrance.

  • Questions?

    Comments? Visit www.cyantificskincare.com

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    CYANTIFIC PROTECTING DAILY BROAD SPECTRUM SPF 30 
    avobenzone, octinoxate, octisalate, homosalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70820-751
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE10 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE70 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 (UNII: I835H2IHHX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LAURYL ALCOHOL (UNII: 178A96NLP2)  
    TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)  
    C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
    C12-14 ISOPARAFFIN (UNII: WP37Z9V66A)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70820-751-011 in 1 BOX07/08/2016
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/08/2016
    Labeler - Beagle Bioproducts Inc. (078463068)

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