Label: ALGENIST- avobenzone, homosalate, octisalate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 8, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Avobenzone 3.0%

    Homosalate 8.0%

    Octisalate 5.0%

  • Purpose

    Sunscreen

    Sunscreen

    Suncreen

  • Uses

    Helps prevent sunburn

    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • 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 consult a doctor if rash occurs

    • Keep out of reach of children
    • If swallowed, get medical help or contact a poison control center right away.
  • Directions

    Apply liberally to the entire face, neck, and chest area in the morning or 15 minutes prior to sun exposure.

    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • Children under 6 months: 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 with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses.
  • Inactive Ingredients

    Water/Aqua/Eau, Silica, Butylene Glycol, Pentylene Glycol, Caprylic/Capric Triglyceride, Glycerin, PEG-100 Stearate, Glyceryl Stearate, Butyrospermum Parkii (Shea Butter), Di-C12-15 Alkyl Fumarate, Cetearyl Alcohol, Cetyl Phosphate, Algae Exopolysaccharides, Malus Domestica Fruit (Apple) Cell Culture Extract, Bambusa Vulgaris (Bamboo) Leaf/Stem Extract, Tetrapeptide-21, Pisum Sativum (Pea) Extract, Enantia Chlorantha Bark Extract, Alaria Esculenta Extract, Sodium Ascorbyl Phosphate, Biotin, Glucosamine HCL, Eucalyptus Globulus Leaf Oil, Ergothioneine, Oleanolic Acid, Stearic Acid, Carbomer, Xanthan Gum, Lecithin, Mannitol, Disodium EDTA, Caprylyl Glycol, Ethylhexylglycerin, Aminomethyl Propanol, Hexylene Glycol, Phenoxyethanol.

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Questions Call toll free 1-877-650-1837

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Carton Label

    ANTI-WRINKLE / ANTI-RIDES

    Regenerative
    Anti-Aging Moisturizer | SPF 20

    Soin Régénérant Anti-âge | FPS 20

    Broad Sprectrum | Ecran Solaire Large Spectre

    ALGENIST

    formulated with Algurinic Aciod

    Biotechnology from San Francisco

    2 US fl. oz / 60 mL

    Principal Display Panel – Carton Label
  • INGREDIENTS AND APPEARANCE
    ALGENIST 
    avobenzone, homosalate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53407-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate80 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    glycerin (UNII: PDC6A3C0OX)  
    Peg-100 Stearate (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Cetyl Phosphate (UNII: VT07D6X67O)  
    APPLE (UNII: B423VGH5S9)  
    Tetrapeptide-21 (UNII: 179JUC43HU)  
    ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)  
    ALARIA ESCULENTA (UNII: EJ9JK8J58D)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    Biotin (UNII: 6SO6U10H04)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    stearic acid (UNII: 4ELV7Z65AP)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    caprylyl glycol (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    mannitol (UNII: 3OWL53L36A)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    hexylene glycol (UNII: KEH0A3F75J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53407-104-601 in 1 BOX
    11 in 1 CARTON
    160 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2012
    Labeler - Solazyme, Inc. (145862012)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhytogenX,Inc010297942MANUFACTURE(53407-104)
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