Label: BROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS- avobenzone, homosalate, ocinoxate, octisalate, octocrylene, oxybenzone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 18, 2014

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  • ACTIVE INGREDIENT

    Active ingredients               Purpose

    Avobenzone 3.0%              Sunscreen
    Homosalate 10%                Sunscreen

    Octinoxate 7.0%                 Sunscreen

    Octisalate 5.0%                  Sunscreen

    Oxybenzone 6.0%              Sunscreen

    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

    Keep out of reach of children. If product is swallowed, get medical help or
    contact a Poison Control Center right away.

    Stop use and ask a doctor if rash occurs

    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.

    Directions
    · Apply liberally 15 minutes before sun exposure
    · Use a water resistant sunscreen if swimming or sweating

    · Reapply at least every 2 hours
    · 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 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

    Acrylates/C10-30 Alyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice powder, Angelica  Polymorpha Sinensis (Dong Quai) Root Extract, Ascorbyl Palmitate, Butylene Glycol, Centella Asiatica (Gotu Kola) Extract, Cetyl Dimethicone, Chamomille Recutita (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nastartium Officiniale (Watercress) Extract, Panax Ginseng (Ginseng) Root Extract, Phenoxyethanol, Phospholipids, Retinyl Palmitate, Rhus Glabra (Sumac) Extract, Steareth-2, Steareth-21, Tocopheryl Acetate, Triethanolamine, Water (Aqua, Eau)

  • PRINCIPAL DISPLAY PANEL

    secondary

    jar

    Bioelements

    Used in Professional Facials

    SPF 50 FaceScreen

    Broad Spectrum

    SPF 50 Sunscreen

    Daily antioxidant moisturizer

    Decreases the risk of skin cancer and early skin aging caused by the sun when used as directed

    68 mL/ 2.3 Fl. Oz.

  • INGREDIENTS AND APPEARANCE
    BROAD SPECTRUM SPF 50 SUNSCREEN  BIOELEMENTS
    avobenzone, homosalate, ocinoxate, octisalate, octocrylene, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-133
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    1,3-BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    RHUS GLABRA BARK (UNII: 7XC0E9WP6U)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49825-133-021 in 1 BOX
    1NDC:49825-133-0168 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/11/2013
    Labeler - Bioelements (174813923)
    Registrant - Bioelements (174813923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Enterprises017701475manufacture(49825-133)
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