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Facescreen (Bioelements)

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LIQUID 1 JAR in 1 CARTON (49825-122-02) > 68 mL in 1 JAR (49825-122-01) (49825-122-01) Label Information

Complete Facescreen Information

  • ACTIVE INGREDIENT

    Active ingredients            Purpose

    Avobenzone 3.0%            Sunscreen

    Homosalate 10%              Sunscreen

    Octinoxate 7.0%               Sunscreen

    Octisalate 5.0%                Sunscreen

    Octocrylene 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 broken or damaged 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 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

    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, Chamomile Recutita  (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nastartium Officinale (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)



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  • PRINCIPAL DISPLAY PANEL

    Bioelements

    SPF 50 FaceScreen

    Broad Spectrum SPF 50 Sunscreen

    68 mL/ 2.3 Fl. Oz.





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  • INGREDIENTS AND APPEARANCE
    FACESCREEN  SPF 50
    avobenzone, homosalate, octinoxate, octisalate, octocrylene,oxybenzone liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49825-122
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 mL  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 mL  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.0 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 mL  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5.0 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49825-122-02 1 in 1 CARTON
    1 NDC:49825-122-01 68 mL in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 03/23/2012
    Labeler - Bioelements (174813923)
    Registrant - Bioelements (174813923)
    Establishment
    Name Address ID/FEI Business Operations
    Cosmetic Enterprises 017701475 manufacture